FLUID-FILLED TEETHER

K083512 · Wiltec Industries , Ltd. · KKO · Apr 22, 2009 · Dental

Device Facts

• Record ID: K083512
• Device Name: FLUID-FILLED TEETHER
• Applicant: Wiltec Industries , Ltd.
• Product Code: KKO · Dental
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Device Story

Fluid-filled teether designed for infants to alleviate teething discomfort. Device provides cooling sensation when chilled and chewed. Used in home environment by infants under caregiver supervision. Simple mechanical device; no electronic components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid-filled teether; cooling mechanism via thermal transfer. No electronic or software components.

Indications for Use

Indicated for teething infants to relieve teething discomfort via a cooling effect.

Regulatory Classification

Identification

A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

Special Controls

*Classification.* Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wiltec Industries Limited C/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Incorporated 5401 South Cottonwood Court Greenwood Village, Colorado 80121

APR 22 2009

Re: K083512

Trade/Device Name: Fluid-Filled Teether Regulation Number: 21 CFR 872.5550 Regulatory Class: II Product Code: KKO Dated: April 16, 2009 Received: April 17, 2009

Dear Mr. Walls:

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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· Page 2- Mr. Walls

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Turner

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use

083512 510(k) Number (if known):

Device Name:

Indications for Use: The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Mulkey for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083512

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