(359 days)
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.
Ora-GUARD Dental Grind Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The Ora-GUARD Dental Grind Guard is intended to be worn while sleeping (e.g., at night or while napping). The material is comfortable to wear, and it can be self-fit by submerging in hot water to make the material malleable to fit on the lower teeth of the oral cavity. Ora-GUARD Dental Grind Guard is constructed of a soft EVA, which contacts the tooth surface and a hard base, which protects bite-through by user when bruxing (polycarbonate). Ora-GUARD Dental Grind Guard is provided in one size that fits most (comfortably fits palate sizes ranging from two to two and one half inches wide).
The provided text is a 510(k) summary for the Ora-GUARD Dental Grind Guard, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does NOT describe the acceptance criteria for a study demonstrating device performance against specific metrics, nor does it present the results of such a study.
Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and intended use. The "Performance data" section refers to testing related to its physical properties and how it functions as a spacer, rather than clinical efficacy or accuracy metrics against a defined standard.
Therefore, I cannot provide the requested information in the format you asked, as the input document does not contain it. The information is geared towards regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.
However, I can extract what is available regarding the "performance data" provided in the document:
What the document does mention about "Performance data":
- Testing type: "Testing related to the measurement of tooth surface spacing with Ora-GUARD Dental Grind Guard and its ability to neutralize anterior/posterior imbalance of teeth grinding on tooth surfaces was conducted."
- Physical properties tested: "The physical properties of the materials were identified including flexural strength, water solubility, and shore hardness and determined to be appropriate for its intended use."
- Method for spacing measurement: "Measuring the tooth surface spacing with and without the subject device using CAT Scan demonstrated that Ora-GUARD Dental Grind Guard acts as a spacer between the upper and lower tooth surfaces, similar to the DenTek Custom Comfort Nightguard Version 2 (K091660)."
- Biocompatibility: "A biocompatibility assessment was conducted according to ISO 10993-1 on the subject device and cytotoxicity testing according to ISO 10993-5 on the materials was provided."
Based on the provided text, I cannot answer the following questions because the information is not present:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance. (This device is not an AI-driven device).
- If a standalone (algorithm only) performance study was done. (This device is not an algorithm).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set. (Not applicable, this is not an algorithm).
- How the ground truth for the training set was established. (Not applicable, this is not an algorithm).
Summary of what is available (though not in the requested tabular format for acceptance criteria):
The "Performance data" section describes the types of testing performed to demonstrate that the Ora-GUARD Dental Grind Guard functions as intended and is safe.
- Functional Testing: It was demonstrated, using CAT Scans, that the Ora-GUARD acts as a spacer between upper and lower teeth, similar to the predicate device (DenTek Custom Comfort Nightguard Version 2). This essentially confirms its physical function in creating separation. No specific quantitative metrics or acceptance criteria for "spacing" are provided, other than it being "similar" to the predicate.
- Material Properties: Flexural strength, water solubility, and shore hardness were measured and deemed "appropriate for its intended use." No specific values or acceptance ranges are given.
- Biocompatibility: Assessments were conducted according to ISO 10993-1 and ISO 10993-5 (cytotoxicity) for the materials. These tests ensure the materials are not harmful to the body. Passing these standards would be the acceptance criterion.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:(K091660) | DenTek Custom Comfort Nightguard Version 2 |
| Device Description: | Ora-GUARD Dental Grind Guard is an over-the-counter dental protector, which is used as a barrierbetween teeth for individuals who grind their teeth.The Ora-GUARD Dental Grind Guard is intended tobe worn while sleeping (e.g., at night or whilenapping). The material is comfortable to wear, and itcan be self-fit by submerging in hot water to make thematerial malleable to fit on the lower teeth of the oralcavity. Ora-GUARD Dental Grind Guard isconstructed of a soft EVA, which contacts the toothsurface and a hard base, which protects bite-through byuser when bruxing (polycarbonate). Ora-GUARDDental Grind Guard is provided in one size that fitsmost (comfortably fits palate sizes ranging from two totwo and one half inches wide). |
| Intended Use: | The Ora-GUARD Dental Grind Guard is a device thatis indicated for protection against bruxism, nighttimeteeth grinding, and jaw clenching. It is intended toreduce damage to teeth and prevent the noise associatedwith teeth grinding and bruxism. |
| Performance data: | Testing related to the measurement of tooth surfacespacing with Ora-GUARD Dental Grind Guard and itsability to neutralize anterior/posterior imbalance ofteeth grinding on tooth surfaces was conducted. Thephysical properties of the materials were identifiedincluding flexural strength, water solubility, and shorehardness and determined to be appropriate for itsintended use. Measuring the tooth surface spacingwith and without the subject device using CAT Scandemonstrated that Ora-GUARD Dental Grind Guardacts as a spacer between the upper and lower toothsurfaces, similar to the DenTek Custom ComfortNightguard Version 2 (K091660). A biocompatibilityassessment was conducted according to ISO 10993-1 onthe subject device and cytotoxicity testing according toISO 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 BeingCompared | PROPOSED DEVICE | PREDICATE DEVICE | Similarities andDifferences |
|---|---|---|---|
| Ora-GUARD DentalGrind Guard(K150492) | DenTek CustomComfort NightguardVersion 2 (K091660) | ||
| Intended Use | Intended to reducedamage to teeth andprevent the noiseassociated with teethgrinding and bruxism. | Intended to reducedamage to the teeth and toprevent the noiseassociated with bruxingor grinding. | Same. Ora-GUARD andthe predicate device areintended for use asmouthguards. |
Table III.1: Proposed and Predicate Device Comparison Matrix
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| Indications forUse | The Ora-GUARD DentalGrind Guard is a devicethat is indicated forprotection againstbruxism, nighttime teethgrinding, and jawclenching. It is intendedto reduce damage toteeth and prevent thenoise associated withteeth grinding andbruxism. | The Custom ComfortNightguard Version 2 isindicated for use forprotection againstbruxism or nighttimeteeth grinding. It isintended to reducedamage to the teeth andto prevent the noiseassociated with bruxingor grinding. | Same. |
|---|---|---|---|
| DeviceDescription | Flexible, moldable guardused as a barrier betweenteeth for bruxism andnighttime teeth grinding. | Flexible, moldable guardused as a barrier betweenteeth for bruxism andnighttime teeth grinding. | Same. |
| Molding Method | Traditional heat & biteself-fit. | Traditional heat & biteself-fit. | Same. |
| Fit | Lower teeth | Upper Teeth | Similar. PerformanceTesting demonstratesequivalence. |
| Reusable | Yes, single patient. | Yes, single patient. | Same. |
| Materials | EVA and a hard base(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.
N/A