(433 days)
No
The device description and performance studies focus on material properties and mechanical function, with no mention of AI or ML.
Yes
The device is indicated for "temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains," which are therapeutic claims.
No
The device is described as a temporary mouthguard for protection and relief of symptoms related to teeth grinding and TMD, not for diagnosing a condition.
No
The device description clearly outlines physical components (mouthpiece frame, alignment guide, VPS putty) and a physical molding process, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Clench Relief Mouth Piece PRO RX is a physical device that is placed in the mouth to protect teeth and provide temporary relief from symptoms related to teeth grinding and jaw clenching. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a physical intervention for mechanical and muscular issues, not a diagnostic test.
- Device Description: The description details the materials and how the device is molded and used within the mouth, not how it processes or analyzes biological samples.
Therefore, the Clench Relief Mouth Piece PRO RX falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.
Product codes (comma separated list FDA assigned to the subject device)
MQC, OCO
Device Description
The Clench Relief Mouth Piece PRO RX is a custom-fit temporary mouthguard which allows the user to achieve a jaw position that alleviates clenching, grinding, and bruxism and help diminish TMD type muscle pain symptoms along with jaw clicking and popping. It allows the prescriber to set and create a new bite plane for the patient that allows the lower jaw to come down and forward from its habitual bite position thus freeing it from its habitual muscle tension. The mouthguard kits contain the Clench Relief Mouthpiece Frame with alignment guide and Clench Relief Fit Material (VPS putty provided as catalyst and base). The mouthpiece frame is packed with mixed putty and placed passively over the lower teeth. The end user must bite on the alignment guide for 2 minutes while the Clench Relief Fit Material sets. Heating of the mouthguard/putty is not required for molding.
The mouthpiece frame and alignment guide are manufactured from ethylvinyl acetate (EVA). The putty is manufactured from vinyl polysiloxane (VPS) which was previously cleared under K821221.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, Jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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)
The following studies were performed on the subject, predicate, and/or reference devices in support of the substantial equivalence determination:
- Biocompatibility
- o ISO 10993-5
- ISO 10993-10 o
- ISO 10993-23 O
- Material hardness per ANSI/ADA 99
- Tear strength per ANSI/ADA 99 ●
- Water sorption per ANSI/ADA 99 ●
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 28, 2023
Frey Oral Technologies LLC David Frey President 433 North Camden Drive, Suite 1070 Beverly Hills, California 90210
Re: K222845
Trade/Device Name: Clench Relief Mouth Piece PRO RX Regulatory Class: Unclassified Product Code: MQC, OCO Dated: October 29, 2023 Received: October 30, 2023
Dear David Frey:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222845
Device Name
Clench Relief Mouth Piece PRO Rx
Indications for Use (Describe)
The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.
| 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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4
510(k) Summary
I. Submitter
Frey Oral Technologies LLC 433 North Camden Drive Suite 1070 Beverly Hills, CA 90210
Contact Person: David Frey, DDS Phone: 818-601-2253 Date Prepared: November 22, 2023
II. Device
| Device Proprietary Name: | Clench Relief Mouth Piece PRO RX |
|---|---|
| Common or Usual Name: | Mouthguard, Prescription |
| Regulation Number: | N/A |
| Product Code: | MQC |
| Device Classification | Unclassified |
III. Predicate Device
Substantial equivalence is claimed to the following device:
-
Brux-TMD QuickSplint, K111066, MigraTherapy LLC ●
Reference device: -
SleepRight® Select-Comfort™ Dental Guard, K212767, Splintek, Inc. ●
IV. Device Description
The Clench Relief Mouth Piece PRO RX is a custom-fit temporary mouthguard which allows the user to achieve a jaw position that alleviates clenching, grinding, and bruxism and help diminish TMD type muscle pain symptoms along with jaw clicking and popping. It allows the prescriber to set and create a new bite plane for the patient that allows the lower jaw to come down and forward from its habitual bite position thus freeing it from its habitual muscle tension. The mouthguard kits contain the Clench Relief Mouthpiece Frame with alignment guide and Clench Relief Fit Material (VPS putty provided as catalyst and base). The mouthpiece frame is packed with mixed putty and placed passively over the lower teeth. The end user must bite on the
5
alignment guide for 2 minutes while the Clench Relief Fit Material sets. Heating of the mouthguard/putty is not required for molding.
The mouthpiece frame and alignment guide are manufactured from ethylvinyl acetate (EVA). The putty is manufactured from vinyl polysiloxane (VPS) which was previously cleared under K821221.
V. Indications for Use
The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.
VI. Comparison of Technological Characteristics
The subject and predicate device have the same intended use. Although there are slight differences in the indications for use statements; these differences do not alter the intended use of the subject devices when compared to the predicate device.
The subject and predicate devices are intended for prescription use and are intended for reuse by a single patient.
The table below compares key technological features between the subject and predicate devices.
| Parameter | Subject Device | Brux-TMD QuickSplint
(K111066) |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Clench Relief Mouth Piece PRO RX is
indicated for protection of teeth and
restorations from injury due to teeth
grinding, bruxism, and jaw clenching;
temporary relief of TMD and bruxism by
reducing muscle tension, and temporary
treatment of TMD along with the relief of
associated headaches and pains. | 1. Protection of teeth and restorations
from injury due to bruxism or
clenching.
2. Temporary relief of Temporo
Mandibular joint Disorder (TMD)
and bruxism by reducing muscle
tension.
3. Temporary treatment of Temporal
Mandibular Disorder (TMD) along
with the relief of associated
headaches and pains. |
| Materials | Ethylene vinyl acetate | Polycarbonate tray |
Technological comparison
6
| Vinyl polysiloxane | Vinyl polysiloxane liner | |
|---|---|---|
| Reusable | Yes, single consumer | Yes, single consumer |
| Design | Partial coverage (posterior bite plate): | |
| preformed mouthpiece. No boiling required. | Partial coverage (anterior bite plate); | |
| preformed mouthpiece. No boiling | ||
| required. |
VII. Performance Data
The following studies were performed on the subject, predicate, and/or reference devices in support of the substantial equivalence determination:
- Biocompatibility ●
- o ISO 10993-5
- ISO 10993-10 o
- ISO 10993-23 O
- Material hardness per ANSI/ADA 99
- Tear strength per ANSI/ADA 99 ●
- Water sorption per ANSI/ADA 99 ●
VIII. Conclusion
The information provided above supports that the Clench Relief Mouth Piece PRO RX is substantially equivalent to the predicate device. Although minor differences in design and technology exist between the subject and predicate device, the testing supports that these differences do not raise any new questions of safety and effectiveness.
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