Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.

Device Description

The Wired Mouth Protector consists of a non-sterile strip of non-latex foam with a slit in the middle that is inserted into the front of the mouth between the teeth and lip area with the slit in the center to provide a soft barrier to help protect the oral mucosa from contact with wired mouth hardware. It is changed three times daily or more often if needed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Wired Mouth Protector." The document indicates that the device has undergone biocompatibility testing. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance (e.g., efficacy in relieving discomfort in patients).

Therefore, based on the provided text, I cannot complete all sections of your request. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance:

The document focuses on biocompatibility and substantial equivalence to a predicate device, rather than detailed clinical performance metrics with acceptance criteria.

Acceptance Criteria	Reported Device Performance
Biocompatibility:
- Non-cytotoxic	- Non-cytotoxic in agar diffusion test (L929 mammalian cells)
	- Non-cytotoxic in MEM elution test (L929 mammalian cells)
- Non-irritating (dermal)	- Primary skin irritation index = 0.0 (rabbits)
- Non-irritating (ocular)	- Non-ocular irritant (rabbit eyes)
- Non-toxic (acute oral)	- Extracts not considered toxic at 40 mL/kg body weight; LD50 > 40 mL/kg b.w. (mice)
Functional Equivalence to Predicate Device:	"The Wired Mouth Protector performs at least as well as the predicate device" in terms of protective function.

Information that cannot be extracted from the provided text:

Sample size used for the test set and the data provenance: The biocompatibility tests were conducted on animal models (rabbits, mice) and cell lines. No human clinical "test set" for performance evaluation is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no clinical test set with ground truth established by experts mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: For biocompatibility, the chemical and biological responses in standardized tests serve as the "ground truth." For clinical efficacy (e.g., discomfort relief), no such study with defined ground truth is presented.
The sample size for the training set: Not applicable. This device does not have a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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12,31,396

P 3 0 2013

510(k) Premarket Notification: Wired Mouth Protector

Elba Laboratories, Inc.

510(k) SUMMARY

I. ADMINISTRATIVE

Submitter:

Elba Laboratories, Inc. 1925 West Maple Road Troy, MI 48084 (248) 288-6098

Contact Person: Michael Froehlich Date of Preparation: September 25, 2013

II. DEVICE NAME

Proprietary Name: Wired Mouth Protector (WMP)

Common Name: Wired Mouth Protector

Classification Name: Wax, Dental, Intraoral; 21 CFR §872.6890

III.PREDICATE DEVICE

Brace Eze; K020009 ; Udent, Inc.

IV. DEVICE DESCRIPTION

Biocompatibility testing of the device has been conducted. The device was shown to be noncytotoxic in the agar diffusion test as well as the MEM elution test using L929 mamalian cells. Primary skin irritation testing in rabbits showed that the device is not considered to be a

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primary skin irritant (Primary Dermal Irritation Index=0.0). Ocular irritation testing in rabbit eyes showed that the device is not an ocular irritant. An acute oral toxicity study in mice showed that extracts were not considered toxic at an oral dose of 40 mL/kg body weight; the LD50 was > 40 mL/kg b.w.

V. INTENDED USE

Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.

VI.COMPARISON TO PREDICATE DEVICE

The Wired Mouth Protector provides a similar function as the predicate device; i.e., protecting oral mucosal tissue from discomfort and damage. The composition of the Wired Mouth Protector differs from that of the predicate (foam vs. gel); however, the safety of the foam material for oral use has been well established in standard biocompatibility testing.

VII. CONCLUSION

Based on design considerations and the results of biocompatibility testing, we conclude that, in terms of protective function, the Wired Mouth Protector performs at least as well as the predicate device. The Wired Mouth Protector is therefore considered to be substantially equivalent to the above-mentioned predicate device.

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Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2013

Elba Laboratories, Incorporated C/O Mr. Richard A. Hamer Vice President/Regulatory Affairs Ferndale Pharma Group, Incorporated 780 West 8 Mile Road FERNDALE MI 48220

Re: K131396

Trade/Device Name: Wired Mouth Protector Regulation Number: 21 CFR 872.6890 Regulation Name: Intraoral Dental Wax Regulatory Class: I Product Code: PFL Dated: July 9, 2013 Received: July 12, 2013

Dear Mr. Hamer:

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 (2) 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 (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image shows the name "Mary S. Bunner -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are clear and legible, and the name is easy to read. The "S." is smaller and more stylized than the rest of the name.

Kwame Ulmer M.S. Acting Division 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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Elba Laboratories, Inc.

510(k) Number (if known): _K131396

Device Name: Wired Mouth Protector

Indications for Use:

Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.

Prescription Use (Per 21 CFR §801.109) Over-the Counter Use __ X

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joel M. Anderson
2013.09.30
13:03:13 -04'00'

Regulation Number and Section

§ 872.6890 Intraoral dental wax.

Link to an amendment published at 90 FR 55985, Dec. 4, 2025. (a)
Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.