Frequently Asked Questions

Get answers to the most commonly asked questions

What is Zendura FLX?

Zendura FLX is engineered specially for fabricating clear aligners and is now widely regarded as far and away the very best commercially available aligner material. A flexible yet highly elastic and crack resistant material, FLX features a unique trilayer construction with an elastomeric inner layer encased in a hard, tough outer shell. That hard outer shell is the secret to FLX’s amazing elasticity and its ability to hug teeth to help effect difficult teeth movements like rotation and extrusion and intrusion.

Compared with competing materials, FLX boasts up to 150% better teeth movement force over a 7-10 day period and a 40% lower insertion force, enhancing patient comfort significantly.

Click here for more information on Zendura FLX.

What is Zendura A?

Zendura A, by comparison, is also referred to as Bay Material’s “classic” or “original” material. The first generation of Zendura A was developed more than a decade ago and today Zendura A is considered the well-established gold standard of retainer materials for its amazing crack resistance and teeth retention properties.

A monolayer material manufactured of a proprietary polyurethane (TPU) resin, many patients with Zendura A retainers have told us their retainers still work as well as the day they were made 5-plus years on from when they were made.

Zendura A is also well suited for retainers for patients who are heavy bruxers. Some customers also use Zendura A for aligners (frequently for multi-thickness aligner systems), for later-stage “finishing” aligners, and for specialty appliances like bite guards.

Click here for more information on Zendura A.

What are the key differences between Zendura FLX and Zendura A?

Zendura FLX is engineered specially for fabricating clear aligners and features a unique trilayer construction with an elastomeric inner layer encased in a hard, tough outer shell. That hard outer shell is the secret to FLX’s amazing elasticity and its ability to hug teeth to help effect difficult teeth movements like rotation and extrusion and intrusion. Compared with competing materials, FLX boasts up to 150% better teeth movement force over a 7-10 day period and a 40% lower insertion force, enhancing patient comfort significantly.

Zendura A, also referred to as Bay Material’s “classic” or “original” material, is a monolayer material manufactured of a proprietary polyurethane (TPU) resin. Developed more than a decade ago, Zendura A today is considered the well-established gold standard of retainer materials for its amazing crack resistance and teeth retention properties. A properly made Zendura A retainer should last from 1 to 5-plus years. Zendura A is also well suited for retainers for patients who are heavy bruxers. Some customers also use Zendura A for aligners (frequently for multi-thickness aligner systems) and for later-stage “finishing” aligners.

Click here for more information on how Zendura FLX compares with Zendura A.

Why is Zendura A named Zendura A?

The letter “A” designates Zendura A as the original or first generation Zendura material. It was first developed more than a decade ago and today is widely considered the gold standard of retainer materials.

Why is polyurethane (TPU) better than polyester (PETG) for making orthodontic thermoplastic materials?

Polyurethane is significantly more elastic, flexible and crack resistant than polyester. It is also significantly more expensive. One pound of the polyurethane resin we developed and use in manufacturing Zendura materials costs about US $18.00, while one pound of the polyester resin used by other material suppliers to make competing orthodontic materials costs only about $1.00.

Polyester is also much easier to work with. Hence the reasons why all of the materials from material suppliers like Essix/Densply, Henry Schein and Keystone are all made of PETG. The PETG they use is a commodity resin and is the same basic resin used to make plastic Coke and Pepsi bottles.

Why does Bay Materials recommend using a “pressure” thermoformer to thermoform Zendura materials?

“Pressure” thermoformers deliver from 30-90 psi of forming pressure, enough to help ensure good adaptation of the material when formed over the teeth model. It also helps ensure good material uniformity throughout the appliance. “Vacuum” thermoformers, by comparison, typically offer only 12-16 psi of forming pressure.

So, achieving good teeth adaptation with a vacuum thermoformer requires more effort and skill. The much higher forming pressure offered by pressure thermoformers also helps to speed thermoforming speed and ensure good continuity from one appliance to the next.

Check the image for a comparison of a poorly and a well thermoformed Zendura appliance.

Why should I thermoform a Zendura sheet within 15 mns of removing it from its moisture barrier foil bag?

All Zendura materials are made using a proprietary polyurethane (TPU) resin we developed that is prone to moisture migration. Hence the reason we recommend you thermoform a sheet of Zendura within 15 mns of removing it from its moisture barrier foil bag.

If you remove a sheet from its foil bag and leave it sitting on your work bench for an hour or so, if there is moisture in the ambient air it may migrate into the plastic and will cause voids (bubbles) to appear in the thermoformed sheet. Those voids are a result of the moisture trapped in the plastic expanding as you heat it during the thermoforming process.

How long should I expect a Zendura A retainer to last?

A properly made and cared for Zendura A retainer should last from 1-5 years. Many of our Zendura A customers have told us that many of their patients using Zendura A retainers have told them their retainers still work as well as the day they were made 5-plus years on from when they were made.

What orthodontic appliances can be fabricated with Zendura A?

Zendura A is the well-established gold standard for retainer materials for its exceptional crack resistance and overall durability. Zendura A is also used for aligners (frequently for multi-thickness aligner systems), for later-stage “finishing” aligners, and for specialty appliances like bite guards.

Is Zendura FLX not suitable for use as a retainer material?

FLX is engineered for aligner use and not for long-term wear usage as a retainer material. The typical wear period for a FLX aligner is 2 weeks.

Why does one side of a sheet of Zendura A have a matte finish?

The matte finish is an anti-reflection property we engineered into the material. When a patient wears a Zendura A retainer or aligner, that anti-reflection property prevents the appliance from reflecting light so no one notices that the patient is wearing a clear appliance.

When measuring the clarity of a retainer/aligner material, what you are really concerned about is what is termed "contact clarity." That refers to the clarity you see when a patient is actually wearing an appliance and it comes into contact with moisture (with saliva). With a Zendura sheet, if you wet your finger and press it on the matte side of the sheet, that area will turn completely transparent, but it won't reflect light. When an appliance reflects light, it's a dead giveaway that someone is wearing an appliance.

Does it matter if I put the matte side face down on the dental model or face up?

Many customers put the matte side down, but it actually doesn’t matter whether it is placed face down or face up.

What is the shelf life of Zendura materials?

5-plus years. One of the unique features of our Zendura products is that they actually perform better as they age.

Are Zendura materials BPA, phthalate, gluten and latex free?

All our Zendura materials are BPA, phthalate, gluten and latex free and are among the safest commercially available orthodontic thermoplastic materials.

Click here to download PDF versions of our SDS (MSDS) documents for our Zendura FLX, Zendura A, and Zendura AT products.

Why are Zendura materials priced as premium materials?

We use a proprietary and very expensive polyurethane (TPU) resin we developed in making our Zendura products. One pound of the polyurethane resin we use costs about US $18.00 per lbs, while one pound of the polyester (PETG) resin other material suppliers use to make competing materials costs only about $1.00.

Polyester is also much easier to work with. Hence the reasons why all of the materials from material suppliers like Essix/Densply, Henry Schein and Keystone are all made of PETG. The PETG they use is a commodity resin and is very similar to the resin used to make plastic Coke and Pepsi bottles.

Do you offer volume discounts?

Yes, beginning with orders of 500 sheets or more. For newer customers, we sometimes offer buy 5+1 and 10+1 deals to help them build an initial inventory of Zendura. Be sure to ask about special sales offers when you place your order over the phone by calling 650-566-0800.

Can I be invoiced for my order?

Yes, but you must place your order by phone by calling 650-566-0800 and selecting Sales Department.

When will Bay Materials offer a Square shape version of Zendura FLX?

That’s on our list of products to make and we plan to start offering it fairly soon. When it is available we will add it as a product for purchase on our ecommerce website at www.zenduradental.com.

When will Bay Materials offer a 120mm diameter Circle version of its 1mm thick material?

That’s on our list of products to make and we plan to start offering it fairly soon. When it is available we will add it as a product for purchase on our ecommerce website at www.zenduradental.com.

Do you have a recommendation on scissors for trimming formed sheets of Zendura?

After thermoforming a Zendura sheet, to quickly remove the excess material we recommend using a large pair of Teflon coated scissors, similar to scissors for cutting corrugated cardboard, to make the initial cut.

We recommend looking on Amazon.com for a suitable pair of scissors. To make the final cutline, we recommend using a high-quality pair crown-and-bridge scissors. Beck Instruments makes a pair of scissors very popular with quite a few of our customers. It cuts through both Zendura FLX and Zendura A material fairly easily. And it makes such a “neat” cutline that many customers tell us they don’t have to polish the final cutline of their Zendura appliances.

EA Beck #500-215 – scissors
EA Beck #500-207 – scissors (for lab techs with smaller size fingers)

To order the Beck Instruments scissors by phone or email:

Carol Swickard
carol@beckinstruments.com
1507 W. Alton Ave,
Santa Ana CA 92704-7219
Tel: (714) 754-1101, (800) 854-0153, Fax: (714) 754-1102
www.beckinstruments.com

Click here for an image of the Beck Instruments recommended scissors.

Do you recommend making a fairly straight cutline or a scalloped cutline when trimming a Zendura aligner or retainer?

We strongly recommend a fairly straight cutline. The published study at link below explains why. It’s very important to have the aligner or retainer material at the gingival margin as thick as possible all along the margin. For aligners that means maximum teeth movement force along that area, and for retainers significantly better teeth retention.

Check the study by clicking here.

Do you have a recommendation for a separation agent to easily remove a dental model from a formed Zendura sheet?

For a simple but effective separation agent, we recommend using a 50/50 mixture of liquid Ivory soap (available at most grocery stores) and water. Use any small spray bottle to spray a very light coat of this solution over a teeth model (alginate or 3D printed). Then use a standard heat gun or a small fan to dry it. It does not need to be bone dry, only dry to the touch. Then thermoform the Zendura sheet over the model as you normally would.

The light coating of liquid Ivory soap/water will make it much easier to remove the model. It is also very easy to wash off the Zendura appliance. Should you still have trouble removing a model from the formed sheet, many of our customers make a small V-shaped cut behind the last molar.

Is Zendura FDA approved?

Both Zendura FLX and Zendura A are Class I products in the US and in the EU. The US FDA does not require us to submit a 510(k) and the EU MDD/MDR does not require Class I products to be made within an ISO certified Quality System.

Our customers use our mechanical test reports and our biocompatibility reports to prepare their own 510K submission to their regulatory body as required for their Class II appliances that are made from Zendura FLX and Zendura A materials.

Where can I download a copy of your SDS (MSDS) for your Zendura FLX, Zendura A, and Zendura AT products?

Click here to download PDF versions of our SDS (MSDS) documents for our Zendura FLX, Zendura A, and Zendura AT products.

Where can I download a CE Certificate?

Click here to download PDF version of our CE Certificate.

Where can I download a Declaration of Conformity?

Click here to download PDF version of our Declaration of Conformity.

Do you sell direct to customers in international locations where you do not have a distributor or reseller?

If you are a customer outside of the U.S., we have distributors and resellers in a number of major international markets. All of them maintain a good inventory of all of our products and do an excellent job of supporting their Zendura customers.

If you are near one, they can get your product to you faster than we can and at a lower shipping cost. If you are not near a distributor or reseller, you can order directly from us. Click here for contact information for our distributors and resellers.

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