WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

K110615 · Bebe Toys Manufactory , Ltd. · KKO · Dec 2, 2011 · Dental

Device Facts

• Record ID: K110615
• Device Name: WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
• Applicant: Bebe Toys Manufactory , Ltd.
• Product Code: KKO · Dental
• Decision Date: Dec 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

Device Story

Water Filled Teether; handheld device for infants/toddlers; provides temporary relief of teething pain/discomfort; used by infants/toddlers under caregiver supervision; non-powered; simple mechanical design.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Water-filled teething ring; non-powered; class II device per 21 CFR 872.5550.

Indications for Use

Indicated for infants and toddlers experiencing pain and discomfort associated with teething.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bebe Toys & Accessories Manufactory, Limited C/O Mr. Paul A. Ware President PW Resources, Incorporated 34 McNamara Street Stoughton, Massachusetts 02072

DEC - 2 2011

Re: K110615

Trade/Device Name: Water Filled Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: November 2, 2011 Received: November 2, 2011

Dear Mr. Ware:

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.

{1}------------------------------------------------

Page 2 - Mr. Ware

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.

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices /Resourcesfor You/Industry/default.htm.

Sincerely yours.

Tenthony V. marta

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

{2}------------------------------------------------

## Section 5

## Statement of Indications for Use

K11 0615

510(k) Number (if known): New: submission Device Name: Water Filled Teether

Indications For Use:

The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

| Prescription Use | _________________ |
|------------------|-------------------|
|------------------|-------------------|

AND/OR

| Over-The-Counter Use | _________________ √ |
|----------------------|---------------------|
|----------------------|---------------------|

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Date)

(Premarket submission 510(k) Number)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Susan Runror

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

510(k) Number: 16110605