THERMOFORMED MOUTHGUARDS

K121365 · Glidewell Laboratories-Sleep Devices Group · MQC · Nov 20, 2012 · DE

Device Facts

• Record ID: K121365
• Device Name: THERMOFORMED MOUTHGUARDS
• Applicant: Glidewell Laboratories-Sleep Devices Group
• Product Code: MQC · DE
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

Device Story

Thermoformed Mouthguards/Nightguards are custom-made, dentist-prescribed dental appliances designed to alleviate pain and damage from bruxism or clenching. The device is worn over upper or lower teeth during sleep to provide a physical barrier between dentition, protecting teeth from wear and tear. The device features a standard flat occlusal plane with slight opposing cusp indentation, customized to the patient's bite. Construction involves biocompatible materials (co-polyester, polyurethane, or ethylene vinyl acetate) thermoformed to fit the patient's specific dental anatomy. The device is non-sterile and intended for single-patient use. By providing a durable occlusal surface, the appliance helps offset the effects of grinding and clenching, potentially reducing associated jaw or facial muscle pain. The device is used in a home setting by the patient following professional diagnosis and prescription.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material biocompatibility certification (DIN/EN 30993-1), and comparison to legally marketed predicate devices.

Technological Characteristics

Custom-fit, thermoformed dental appliance. Materials: Co-polyester, polyurethane, and ethylene vinyl acetate (EVA). Biocompatibility: DIN/EN 30993-1 compliant, BPA-free. Design: Standard flat occlusal plane with cusp indentation. Non-sterile. No electronic components or software.

Indications for Use

Indicated for patients requiring protection against bruxism and nighttime teeth grinding. The device creates a barrier between upper and lower dentition to protect overall occlusion.

Predicate Devices

• Doctor's® NightGuard™ (K053580)
• Ez Splint & Ez Splint PM (K022809)
• Dr. Hays Bite Guard (K014079)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a black triangle on the left and the company name on the right. The triangle is a geometric shape with sharp angles. The company name is written in a bold, sans-serif font.

B.

12-1365

NOV 2 0 2012

## 005-510 (k) Summary-807.92(c)

This 510 (K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

#### SUBMITTER INFORMATION A.

Glidewell Laboratories-Sleep Devices Company Name: Group Company Address: 2181 Dupont Dr. Irvine, CA 92612 Company Phone: [phone] Company FAX: Armin Zehtabchi, [phone] Contact Person: Kathleen Dragovich, [phone] Date Summary Prepared: 10/31/2012 DEVICE IDENTIFICATION Thermoformed Mouthguards/Nightguards Trade/Proprietary Name: 21 CFR Reference: Unclassified Mouthguard, Prescription 21 CFR Common Name: Class II Classification: Product Code: MOC Panel: Dental

#### IDENTIFICATION OF PREDICATE DEVICE C.

Trade/Proprietary Name:

Doctor's® NightGuard™ (K053580), Ez Splint & Ez Splint PM (K022809) and Dr. Hays Bite Guard (K014079)

#### D. DEVICE DESCRIPTION

The Thermoformed Mouthguards/Nightguards are designed to alleviate the pain and damage caused by bruxing or clenching of the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching of the teeth.

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Image /page/1/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a geometric shape resembling a prism on the left, followed by the company name in a simple, sans-serif font. The word "PRISMATIK" is on the first line, and "DENTALCRAFT, INC." is on the second line.

These aches can be alleviated with a dentist-prescribed, custom-made Thermoformed Mouthguard/Nightguards.

These customized devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching while protecting teeth from daily wear and tear.

The design of Thermoforming Mouthguards/Nightguards is the same, and the only difference is the material in terms of hardness, softness or semi-softness. Each Mouthguard/Nightguard is made with a standard flat occulusal plane and slight opposing cusp indentation to each patient's specific bite plane needs that could be determined by a dentist after diagnosis of bruxism. The Comfort H/STM Hard Soft Bite Splint is the most widely prescribed bite splint due to its comfort and fit. The soft internal surface rests comfortably against the teeth and gums, while the hard occlusal surface provides durability and bonds.

Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials. The materials are purchased from Erkodent Company that is DIN EN ISO 13485 certified. The ISO-certified thermoforming materials are BPA-free and are approved for dental use. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1.

Glidewell has followed the FDA's Guidance's for Class II devices, and has met the following requirements:

- (1) It conforms to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in 21 CFR 807. Subpart E.
- (2) Has identified the predicate devices in lieu of performing biocompatibility testing, although the purchased materials are manufactured using medical grade material and precision extruding methods for the highest level of biocompatibility and tolerances. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1 and a copy of the Safety Data Sheet for the purchased materials (Erkoflex, Erkodur, Erkolog-Pro) is included.

Image /page/1/Picture/8 description: The image shows two clear dental aligners against a black background. The top aligner is labeled as having a "hard outer layer" that is "durable and sparkling clear." The bottom aligner is labeled as having a "soft inner layer" that "rests comfortably against the teeth and gums."

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Image /page/2/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font.

Glidewell Laboratories-Sleep Devices Group's Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials including Ethylene vinyl acetate (also known as EVA) which is similar to predicate devices' materials (Doctor's® NightGuard™, K053580) such as DuPont™ Elvax.

Elvax® resins are copolymers of ethylene and vinyl acetate and these specialty thermoplastic copolymers are inherently flexible, resilient, tough, and show excellent resistance to ozone and environmental stress cracking. Although Elvax® resins are available in various grade series; however, they all contain general properties. The following chart demonstrates the physical properties:

| Product | Melting Point | Density | Hardness Shore | Tensile Strength |
|------------------------------------------------------|---------------|---------|----------------|------------------|
| Glidewell<br>Laboratories-<br>Sleep Devices<br>Group | >72 °C | > 0.92 | > 82/ | > 15 |
| Elvax | >72 °C | > 0.92 | > 82/ | > 15 |

Glidewell Laboratories-Sleep Devices Group included a Technical Specifications sheet. This technical information sheet will help to find a good understanding of the physical properties of Materials that comply with the guidelines for European medical products 93/42/EEC or 2007/47/EC.

## Biocompatibility

Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials. The ISO-certified thermoforming materials are BPA-free and are approved for dental use. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1.

Glidewell Laboratories-Sleep Devices Group included two test reports for Cytotoxicity. The summary of the test results indicate that thermoformed materials do not release substances in cytotoxic concentrations during a permanent 24 h contact of 4.5 cm- surface area to 1 ml physiological fluid.

In addition, a copy of the MSDS for Elvax material that is manufactured by DuPont is included.

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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The triangle is partially obscured by a curved line. The company name is written in a bold, sans-serif font.

#### E. INDICATIONS FOR USE

The Thermoformed Mouthguards/Nightguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

#### SUBSTANTIAL EQUIVALENCE F.

The Thermoformed Mouthguards/Nightguards are substantially equivalent to the Doctor's® NightGuard™ (K053580), Ez Splint & Ez Splint PM (K022809) and Dr. Hays Bite Guard (K014079). These mouthguards/nightguards are substantially equivalent in intended use, indication for use, material, design and performance.

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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The triangle is a stylized prism, and the company name is written in a bold, sans-serif font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.

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# Comparison of Predicate Devices

| Elements of<br>Comparison | Thermoformed<br>Mouthguards | Doctor's®<br>NightGuard™<br>(K053580) | Dr. Hays Bite<br>Guard<br>(K014079) | Ez Splint &<br>Ez Splint PM<br>(K022809) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Thermoformed<br>Mouthguards/Nightg<br>uards are intended<br>for protection<br>against bruxism and<br>nighttime teeth<br>grinding. They<br>create a barrier<br>between the upper<br>and lower dentition<br>to protect the<br>patient's overall<br>occlusion. | The Doctor's®<br>NightGuard™ is<br>indicated for<br>protection against<br>bruxism or<br>nighttime teeth<br>grinding. It is<br>intended to reduce<br>damage to the teeth<br>and to prevent the<br>noise associated<br>with bruxing or<br>grinding. | Protection<br>against teeth<br>grinding,<br>bruxism and jaw<br>clenching.<br>Short-term pain<br>relief from<br>muscle spasm<br>due to occlusal<br>interference. | Protection<br>against teeth<br>grinding,<br>bruxism and jaw<br>clenching.<br>Short-term pain<br>relief from<br>muscle spasm<br>due to occlusal<br>interference. |
| Material | Approved<br>Biocompatible<br>Materials:<br>Co-Polyester,<br>Polyurethane, Ethyl<br>Vinyl Acetate<br>(Erkoflex, Erkodur,<br>Erkolog-Pro) | Elvax Resin (a<br>copolymer of<br>ethylene and vinyl<br>acetate) | Lexan & Elvax | Elvax Resin and<br>Polyurethane |
| Design | Pre-formed Device | Pre-formed Device | Pre-formed<br>Device | Pre-formed<br>Device |
| Prescription<br>Device | Yes | No | Yes | Yes |
| Re-Usable Device | Yes, Single<br>Consumer/Patient | Yes<br>Single<br>Consumer/Patient | Yes, Single<br>Consumer/<br>Patient | Yes, Single<br>Consumer/Patie<br>nt |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Method of<br>Manufacturing | Thermo-Molding<br>Custom-Fit | Thermo-Molding<br>Custom-Fit | Thermo-Molding<br>Custom-Fit | Injection<br>Molding |

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The triangle is a geometric shape with sharp angles. The text is in a bold, sans-serif font.

#### NON-CLINICAL TESTING G.

Glidewell Laboratories-Sleep Devices Group has relied on the existing predicated devices for the safety and the effectiveness of its Thermoformed Mouthguard/Nightguards devices. In addition, the ISO-certified Erkodent thermoforming materials are BPA-free and are approved for dental use. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1. Therefore, the Thermoformed Mouthguards/Nightguards are safe and effective for its intended use.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2012

Mr. Armin Zehtabchi

Senior Regulatory Affairs / Quality Assurance Coordinator Glidewell Laboratories-Sleep Devices Group 2181 Dupont Drive Irvine, California 92612

Re: K121365

Trade/Device Name: Thermoformed Mouthguards Regulation Number: Unclassified Regulation Name: Mouthguard, prescription Regulatory Class: Unclassified Product Code: MOC Dated: October 31, 2012 Received: November 2, 2012

Dear Mr. Zehtabchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In ' addition. FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Zehtabchi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame O. Ulme

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital,

Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows the logo for Glidewell Laboratories. The logo consists of the letters 'GL' in a square on the left, and the words 'GLIDEWELL LABORATORIES' in bold, sans-serif font on the right. The logo is black and white.

Sleep Devices Group 2181 Dupont Dr., Irvine, CA 92612

## 004-Indications for Use Statement

510 (K) Number (if known): To be determine

Thermoformed Mouthguards Device Name:

> Indications for Use: The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

Over-the-Counter Use: Yes | | Prescription Use: Yes No No (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

10-13-2013 11 බිශ්‍රී ලංකාවේ පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහ

Kwame O. Ulmer

Digitally signed by Kwame O. Ulmer
DN: C=US, O=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Kwame O. Ulme
0.9.2342.19200300.100.1.1=1300483618
Date: 2012.11.23 10:50:47 -05'00

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number: K121365

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