Ora-GUARD Dental Grind Guard

K150492 · Bite Tech, Inc. · OBR · Feb 19, 2016 · DE

Device Facts

• Record ID: K150492
• Device Name: Ora-GUARD Dental Grind Guard
• Applicant: Bite Tech, Inc.
• Product Code: OBR · DE
• Decision Date: Feb 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Ora-GUARD Dental Grind Guard is a device that is indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching. It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Device Story

Ora-GUARD Dental Grind Guard is an over-the-counter dental protector for nighttime use. Device consists of soft EVA material for tooth contact and hard polycarbonate base to prevent bite-through. User self-fits device by submerging in hot water to make material malleable, then molding to lower teeth. Device acts as physical spacer between upper and lower teeth to neutralize grinding forces and prevent tooth contact. Used by patients at home during sleep or naps. Benefits include reduced dental damage and noise reduction associated with bruxism. Healthcare providers may recommend use based on patient symptoms of grinding or clenching.

Clinical Evidence

Bench testing only. Evaluated tooth surface spacing with and without device using CAT scans to confirm spacer function. Physical properties tested included flexural strength, water solubility, and shore hardness. Biocompatibility assessment conducted per ISO 10993-1; cytotoxicity testing performed per ISO 10993-5.

Technological Characteristics

Materials: soft EVA (tooth contact) and polycarbonate (hard base). Form factor: one-size-fits-most, moldable via heat-and-bite method. Non-sterile. Standalone device.

Indications for Use

Indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching in individuals requiring a dental barrier to reduce tooth damage and noise.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

• DenTek Custom Comfort Nightguard Version 2 (K091660)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Bite Tech Inc. c/o Mr. Alex Varond Regulatory Counsel Hyman, Phelps & McNamara, P.C. 700 13th Street NW, Suite 1200 Washington, DC 20005

Re: K150492

Trade/Device Name: Ora-GUARD Dental Grind Guard Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OBR Dated: December 24, 2015 Received: December 28, 2015

Dear Mr. Varond:

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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. 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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#### II. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150492

Device Name Ora-GUARD Dental Grind Guard

### Indications for Use (Describe)

The Ora-GUARD Dental Grind Guard is a device that is indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching.

It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY Ora-GUARD Dental Grind Guard

| Submitter Name: | Bite Tech Inc. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 20 Glover Avenue, Norwalk CT 06850 |
| Contact Person: | Melanie McNichol for Jeff Padovan |
| Phone Number: | 203-202-3239 |
| Fax Number: | 203-987-6802 |
| Date Prepared: | February 18, 2016 |
| Device Trade Name: | Ora-GUARD Dental Grind Guard |
| Device Common Name: | Mouthguard, Over-the-counter |
| Product Code: | OBR |
| Regulation Number: | Unclassified |
| Predicate Device:<br>(K091660) | DenTek Custom Comfort Nightguard Version 2 |
| Device Description: | Ora-GUARD Dental Grind Guard is an over-the-<br>counter dental protector, which is used as a barrier<br>between teeth for individuals who grind their teeth.<br>The Ora-GUARD Dental Grind Guard is intended to<br>be worn while sleeping (e.g., at night or while<br>napping). The material is comfortable to wear, and it<br>can be self-fit by submerging in hot water to make the<br>material malleable to fit on the lower teeth of the oral<br>cavity. Ora-GUARD Dental Grind Guard is<br>constructed of a soft EVA, which contacts the tooth<br>surface and a hard base, which protects bite-through by<br>user when bruxing (polycarbonate). Ora-GUARD<br>Dental Grind Guard is provided in one size that fits<br>most (comfortably fits palate sizes ranging from two to<br>two and one half inches wide). |
| Intended Use: | The Ora-GUARD Dental Grind Guard is a device that<br>is indicated for protection against bruxism, nighttime<br>teeth grinding, and jaw clenching. It is intended to<br>reduce damage to teeth and prevent the noise associated<br>with teeth grinding and bruxism. |
| Performance data: | Testing related to the measurement of tooth surface<br>spacing with Ora-GUARD Dental Grind Guard and its<br>ability to neutralize anterior/posterior imbalance of<br>teeth grinding on tooth surfaces was conducted. The<br>physical properties of the materials were identified<br>including flexural strength, water solubility, and shore<br>hardness and determined to be appropriate for its<br>intended use. Measuring the tooth surface spacing<br>with and without the subject device using CAT Scan<br>demonstrated that Ora-GUARD Dental Grind Guard<br>acts as a spacer between the upper and lower tooth<br>surfaces, similar to the DenTek Custom Comfort<br>Nightguard Version 2 (K091660). A biocompatibility<br>assessment was conducted according to ISO 10993-1 on<br>the subject device and cytotoxicity testing according to<br>ISO 10993-5 on the materials was provided. |

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Summary of Technological

Characteristics: The table below (Table III.1) compares the technological characteristics of the Ora-GUARD Dental Grind Guard and the DenTek Custom Comfort Nightguard Version 2 (K091660).

| Feature Being<br>Compared | PROPOSED DEVICE | PREDICATE DEVICE | Similarities and<br>Differences |
|---------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Ora-GUARD Dental<br>Grind Guard<br>(K150492) | DenTek Custom<br>Comfort Nightguard<br>Version 2 (K091660) | |
| Intended Use | Intended to reduce<br>damage to teeth and<br>prevent the noise<br>associated with teeth<br>grinding and bruxism. | Intended to reduce<br>damage to the teeth and to<br>prevent the noise<br>associated with bruxing<br>or grinding. | Same. Ora-GUARD and<br>the predicate device are<br>intended for use as<br>mouthguards. |

# Table III.1: Proposed and Predicate Device Comparison Matrix

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| Indications for<br>Use | The Ora-GUARD Dental<br>Grind Guard is a device<br>that is indicated for<br>protection against<br>bruxism, nighttime teeth<br>grinding, and jaw<br>clenching. It is intended<br>to reduce damage to<br>teeth and prevent the<br>noise associated with<br>teeth grinding and<br>bruxism. | The Custom Comfort<br>Nightguard Version 2 is<br>indicated for use for<br>protection against<br>bruxism or nighttime<br>teeth grinding. It is<br>intended to reduce<br>damage to the teeth and<br>to prevent the noise<br>associated with bruxing<br>or grinding. | Same. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Device<br>Description | Flexible, moldable guard<br>used as a barrier between<br>teeth for bruxism and<br>nighttime teeth grinding. | Flexible, moldable guard<br>used as a barrier between<br>teeth for bruxism and<br>nighttime teeth grinding. | Same. |
| Molding Method | Traditional heat & bite<br>self-fit. | Traditional heat & bite<br>self-fit. | Same. |
| Fit | Lower teeth | Upper Teeth | Similar. Performance<br>Testing demonstrates<br>equivalence. |
| Reusable | Yes, single patient. | Yes, single patient. | Same. |
| Materials | EVA and a hard base<br>(polycarbonate). | EVA and hard base. | Similar. |
| Biocompatibility | Biocompatible | Biocompatible | Same. |
| Sterility | Non-sterile | Non-sterile | Same. |

The Ora-GUARD Dental Grind Guard, like the predicate device, cushions the teeth and keeps the upper teeth from contacting the bottom teeth. In this way, Ora-GUARD Dental Grind Guard, like the predicate device, acts as a barrier between teeth. The technological characteristics of the Ora-GUARD Dental Grind Guard and the predicate device are similar. The subject device and predicate have slightly different Intended Use language. However, the difference in language does not change the intended use or substantial equivalence. Any minor differences between the Ora-GUARD Dental Grind Guard and predicate device are minor and do not raise issues regarding substantial equivalence.

Conclusion: The Ora-GUARD Dental Grind Guard is substantially equivalent to the predicate device. The Ora-GUARD Dental Grind Guard and the predicate device have the same intended use, indications for use, and principles of operation, and similar technological characteristics. The minor technological differences between the Ora-GUARD Dental Grind Guard (lower jaw product

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versus upper jaw product) and its predicate device raise no new questions of substantial equivalence.