The Oralgiene Tongue Cleaner is a "T" shaped manual device used in the same manner as other items already in the marketplace. It is all in one piece and has mild ridges, but no sharp edges. It is composed of a durable and safe plastic.

AI/ML Overview

The provided 510(k) summary for the Oralgiene Tongue Cleaner does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a premarket notification for a medical device (tongue cleaner) and primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. This type of submission relies on comparing the new device's features and intended use to those of previously cleared devices, rather than presenting new performance data against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and studies from the given input.

Here's what the document does provide:

Intended Use: "The Oralgiene Tongue Cleaner is intended to be used to remove plaque and food debris from the surface of the tongue. The device is normally used in conjunction with cleaning the teeth and serves a purpose similar to brushing the tongue. Promotes a clean mouth and fresher breath."
Predicate Devices: Tongue Klean (K973175) and Breath-So-Fresh Tongue Cleaner (K972644). The clearance of the Oralgiene Tongue Cleaner is based on its substantial equivalence to these predicate devices.

To answer your request, a different type of document (e.g., a clinical study report or a design verification report) would be needed.

Summary

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5/4/99

K990244

510K Summary of Safety and Effectiveness for Oralgiene Tongue Cleaner

1) SUBMITTER

Name:	Oralgiene USA, Inc.
Address:	8460 Higuera StreetCulver City, CA 90232
Telephone:	(310) 204-7888
Fax:	310-204-7893
Contact:	Bill MuckleroySteven Kofsky
Date:	February 3, 1999

Owner ID: 9031622

2) NAME OF DEVICE:

Proprietary Name: Oralgiene Tongue Cleaner Common Name: Tongue Cleaner/Tongue Scraper Classification: Not Known Product Code: LCN

3) PREDICATE DEVICES:

Tongue Klean (K973175)

Breath-So-Fresh Tongue Cleaner (K972644)

4) DESCRIPTION OF DEVICE

5) INTENDED USE

The Oralgiene Tongue Cleaner is intended to be used to remove plaque and food debris from the surface of the tongue. The device is normally used in conjunction with cleaning the teeth and serves a purpose similar to brushing the tongue. Promotes a clean mouth and fresher breath.

Propose labeling and instruction is attached as Appendix I

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 MAY

Mr. Bill Muckleroy Oralqiene USA, Incorporated 8460 Hiquera Street Culver City, California 90232

Re : K990344 Oralgiene Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: LCN February 3, 1999 Dated: February 4, 1999 Received:

Dear Mr. Muckleroy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ್ಕಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Muckleroy

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ORALGIENE TONGUE CLEANER

Indications For Use:

To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ 902 41

Prescrintian I Ise (Per 21 CFR 801.109) Over-The-Counter Use

Regulation Number and Section

§ 872.6855 Manual toothbrush.

(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(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.