(359 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a dental guard, with no mention of AI or ML technology.
No.
The device is intended to provide protection against bruxism and teeth grinding, not to treat a disease or condition for therapeutic benefit.
No
The device is described as a "Dental Grind Guard" intended for protection against bruxism, nighttime teeth grinding, and jaw clenching. Its purpose is to reduce damage to teeth and prevent noise, acting as a physical barrier. There is no mention of it being used to diagnose bruxism or any other condition; rather, it is a treatment and protective device.
No
The device description clearly states it is a physical dental protector made of EVA and polycarbonate, intended to be worn in the mouth. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Ora-GUARD Function: The Ora-GUARD Dental Grind Guard is a physical device worn in the mouth to protect teeth from grinding and clenching. It does not analyze any biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use clearly states protection against bruxism and reducing damage, not diagnosing or monitoring a condition through in vitro analysis.
- Device Description: The description focuses on the physical properties and how it acts as a barrier, not on any analytical or diagnostic function.
Therefore, based on the provided information, the Ora-GUARD Dental Grind Guard is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (lower teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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. 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). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 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). | |
| 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. | |
| Performance data: | 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. 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. 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). 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. |
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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
Compared | PROPOSED DEVICE | PREDICATE DEVICE | Similarities and
Differences |
|---------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Ora-GUARD Dental
Grind Guard
(K150492) | DenTek Custom
Comfort Nightguard
Version 2 (K091660) | |
| Intended Use | Intended to reduce
damage to teeth and
prevent the noise
associated with teeth
grinding and bruxism. | Intended to reduce
damage to the teeth and to
prevent the noise
associated with bruxing
or grinding. | Same. Ora-GUARD and
the predicate device are
intended for use as
mouthguards. |
Table III.1: Proposed and Predicate Device Comparison Matrix
5
| Indications for
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. | The Custom Comfort
Nightguard Version 2 is
indicated for use for
protection against
bruxism or nighttime
teeth grinding. It is
intended to reduce
damage to the teeth and
to prevent the noise
associated with bruxing
or grinding. | Same. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Device
Description | Flexible, moldable guard
used as a barrier between
teeth for bruxism and
nighttime teeth grinding. | Flexible, moldable guard
used as a barrier between
teeth for bruxism and
nighttime teeth grinding. | Same. |
| Molding Method | Traditional heat & bite
self-fit. | Traditional heat & bite
self-fit. | Same. |
| Fit | Lower teeth | Upper Teeth | Similar. Performance
Testing demonstrates
equivalence. |
| 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
6
versus upper jaw product) and its predicate device raise no new questions of substantial equivalence.