K Number

Device Name

Mouth Guard (ATG0603R)

Manufacturer

Reazeal Corp

Date Cleared

2023-11-06

(133 days)

Product Code

OBR

Regulation Number

N/A

Intended Use

The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

Device Description

The Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180933

Reference Devices

K183315

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical function of a thermoplastic mouth guard, with no mention of AI or ML technologies.

Therapeutic

No
The device is intended for protection against bruxism and to reduce associated noise and damage, not to treat a disease or condition therapeutically.

Diagnostic

No
The device description states its purpose is "protection against bruxism or nighttime teeth grinding" and "to reduce damage to the teeth and reduce the noise associated with bruxing or grinding," indicating it is a protective and therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical mouth guard constructed of thermoplastic material, which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The Mouth Guard described here is a physical device worn in the mouth. Its function is to physically protect teeth and reduce noise by creating a barrier between the upper and lower teeth. It does not analyze any biological specimens or provide diagnostic information about a person's health condition.
Intended Use: The intended use is for protection against the physical effects of bruxism (teeth grinding), not for diagnosing or monitoring bruxism itself.

The description clearly indicates a physical, mechanical device for protection, not a diagnostic test performed on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

Product codes (comma separated list FDA assigned to the subject device)

OBR

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity

Indicated Patient Age Range

Adults 18 and older

Intended User / Care Setting

Home

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)

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the proposed device including hardness, tear strength, impact and rebound, water absorption, impression test, separation test, stability test to demonstrate its effectiveness.
The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device.
Additionally, the following tests for biocompatibility were conducted on the Mouth Guard: Cytotoxicity, Oral Mucosa Irritation, Skin Sensitization, Acute systemic toxicity, Sub chronic systemic toxicity, Genotoxicity.
The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant.

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.

K180933

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.

K183315

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

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 6, 2023

Reazeal Corp % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K231865

Trade/Device Name: Mouth Guard (ATG0603R) Regulatory Class: Unclassified Product Code: OBR Dated: June 26, 2023 Received: June 26, 2023

Dear Ivy Wang:

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.

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 OS 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).

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

Indications for Use

510(k) Number (if known) K231865

Device Name Mouth Guard (ATG0603R)

Indications for Use (Describe)

The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

K231865

Prepared date: 11/03/2023 A. Applicant: REAZEAL CORP Address: 1226 NORTH KING ST. #485 WILMINGTON DELAWARE 19801 Contact Person: Fuhua Liu Tel: +8613014295243 Email: carolanmanthey564@gmail.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Mouth Guard Common Name: Over-the-Counter Dental Guard Model: ATG0603R

Regulatory Information Classification Name: Mouthguard, Over-the Counter Regulation Number: N/A Product Code: OBR Device Class: Unclassified Review Panel: Dental

C. Predicate device:

Predicate - K180933 DenTek Ultimate Dental Guard Medtech Products Inc.

Reference device – K183315 CustMBite Dental Guard Dental Choice Holdings, LLC

D. Indications for use of the device:

The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

E. Device Description:

The Mouth Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.

Table 1 General Comparison
Device	Proposed Device	Predicate Device	Reference Device	Result
510K number	K231865	K180933	K183315	-
Model name	Mouth Guard	DenTek Ultimate
Dental Guard	CustMBite Dental
Guard	-
Classification	Unclassified	Unclassified	Unclassified	Same
Regulation	N/A	N/A	N/A	Same
Product code	OBR	OBR	OBR	Same
Indications for use	The Mouth Guard is
indicated for protection
against bruxism or
nighttime teeth grinding.
It is intended to reduce
damage to the teeth and
reduce the noise
associated with bruxing or
grinding.	The DenTek
Ultimate™ Dental
Guard is indicated for
protection against
bruxism or nighttime
teeth grinding. It is
intended to reduce
damage to the teeth
and reduce the noise
associated with
bruxing or grinding.	The CustMBite
Dental Guard is an
over-the-counter
dental guard
indicated for the
protection against
bruxism - the
nighttime clenching
and grinding of the
teeth.
It is intended for use
in the mouth at night
to reduce damage to
the teeth and to
prevent the noise
associated with teeth
grinding.
The CustMBite
Dental Guard is
intended for
individuals age 18
and older.	Same
with
predicate
device
Intended use	Keep upper and lower
teeth separated during
sleep.	Keep upper and
lower teeth separated
during sleep.	Keep upper and
lower teeth
separated during
sleep.	Same
OTC use	Yes	Yes	Yes	Same
Target population	Adults 18 and older	Adults 18 and older	Adults 18 and older	Same
Technological
characteristics	Flexible, moldable guard
used as a barrier between
teeth.	Flexible, moldable
guard used as a
barrier between teeth.	Flexible, moldable
guard used as a
barrier between	Same
Material	Ethylene-vinyl acetate
copolymer	Ethylene-vinyl
acetate copolymer	Propylene-based
elastomer	Same
with
predicate
device.
Design	Full occlusion,
boil-and-fit dental guard	Posterior occlusion,
boil-and-fit dental
guard	Full occlusion,
boil-and-fit dental
guard	Same
with
reference
device.
Method
of
manufacture	Injection molding	Injection molding	Injection molding	Same
Method of cleaning	Scrub with toothbrush,
liquid soap and cold water	Toothpaste or
mouthwash, brush
followed by cool
water rinse.	Scrub with
toothbrush,
toothpaste and cold
water	Similar
Fit	One size fits all via
traditional heat and bite.	One size fits all via
traditional heat and
bite.	One size fits all via
traditional heat and
bite.	Same
Multiple use device	Yes	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Leaflet included	Yes	Yes	Yes	Same
Accessories	Storage case	Storage case	Storage case	Same
Use environment	Home	Home	Home	Same
Anatomical site of
use	Oral cavity	Oral cavity	Oral cavity	Same

F. Comparison with predicate device

Discussion:

The table above identifies a few minor differences between the proposed device and the predicate device.

The design of the proposed device and reference device is full occlusion while the predicate device is posterior occlusion. Both of the two structures can achieve the intended use. This difference will not affect the safety and performance of the device.

The cleaning method of the two devices are slightly different, but both of them use toothbrush to scrub the devices and rinse with water. This difference will not affect the safety and effectiveness of

the proposed device.

The dimension of the proposed device is different with the predicate device, since it is a full occlusion design, which will not affect the safety and effectiveness of the proposed device.

G. Non-Clinical Test Conclusion

The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device.

Additionally, the following tests for biocompatibility were conducted on the Mouth Guard.

Cytotoxicity
Oral Mucosa Irritation ●
Skin Sensitization
Acute systemic toxicity
Sub chronic systemic toxicity
Genotoxicity

The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate.

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K180933.