← Product Code OBR · K231865 # Mouth Guard (ATG0603R) (K231865) _Reazeal Corp · OBR · Nov 6, 2023 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K231865 ## Device Facts - **Applicant:** Reazeal Corp - **Product Code:** OBR - **Decision Date:** Nov 6, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## 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 Story Mouth Guard (ATG0603R) is an OTC, boil-and-fit dental guard for nighttime use by adults. Constructed of thermoplastic ethylene-vinyl acetate copolymer; user heats in boiled water and molds bite pads to teeth. Worn on upper teeth to maintain separation between upper and lower arches; acts as physical barrier to prevent tooth-to-tooth contact. Reduces noise and damage associated with bruxism. Used in home environment; patient self-operates. No electronic components or software. ## Clinical Evidence No clinical data. Bench testing only, including hardness, tear strength, impact, rebound, water absorption, impression, separation, and stability tests. Biocompatibility testing included cytotoxicity, oral mucosa irritation, skin sensitization, acute/sub-chronic systemic toxicity, and genotoxicity. ## Technological Characteristics Thermoplastic ethylene-vinyl acetate copolymer; injection molded; boil-and-fit; full occlusion; non-sterile; home use; manual cleaning. No energy source, connectivity, or software. ## Regulatory 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 Ultimate Dental Guard ([K180933](/device/K180933.md)) ## Reference Devices - CustMBite Dental Guard ([K183315](/device/K183315.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ # 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) ### 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." {4}------------------------------------------------ ## 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: {5}------------------------------------------------ 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 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. 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 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. 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. --- **Source:** [https://fda.innolitics.com/device/K231865](https://fda.innolitics.com/device/K231865) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com