FLUID-FILLED TEETHER

K092910 · Qualiman Industrial Co., Ltd. · KKO · Dec 18, 2009 · Dental

Device Facts

• Record ID: K092910
• Device Name: FLUID-FILLED TEETHER
• Applicant: Qualiman Industrial Co., Ltd.
• Product Code: KKO · Dental
• Decision Date: Dec 18, 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 to provide cooling relief for teething infants. Device is intended for over-the-counter use by infants under caregiver supervision. Provides soothing effect through cooling; no complex electronics, software, or active components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid-filled teething ring; passive cooling mechanism. No electronic, software, or active 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Qualiman Industrial Company Limited C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 5401 South Cottonwood Court Greenwood Village, Colorado 80121

Re: K092910

Trade/Device Name: Fluid-Filled Teether Regulation Number: 21CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: December 11, 2009 Received: December 14, 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.

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.

DEC 1 8 2009

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## Page 2- Mr. Walls

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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K09-2910

## Indications for Use

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 (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abshertz DDS for Dr. K.P. Muly (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092910

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