BABY SNOOPY WATER FILLED TEETHER, MODEL 95367

K052513 · Delta Enterprise Corporation · KKO · Jun 28, 2006 · Dental

Device Facts

• Record ID: K052513
• Device Name: BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
• Applicant: Delta Enterprise Corporation
• Product Code: KKO · Dental
• Decision Date: Jun 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator -teether then acts as a cold compress for baby's gums and helps reduce the discomfort of teething

Device Story

Baby Snoopy Water Filled Teether (Model 95367) is a handheld teething device. User cleans teether in warm soapy water, rinses, and chills in a refrigerator. Once chilled, the device is applied to the infant's gums to provide a cold compress effect, intended to reduce teething-related discomfort. Device is for over-the-counter use by caregivers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Water-filled teething ring; handheld form factor; non-powered; non-sterile; intended for refrigeration.

Indications for Use

Indicated for infants experiencing teething discomfort. Used as a cold compress for gums.

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 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2006

Delta Enterprise, Corporation C/O Ms. Maria E. Celis Associate Neville Peterson. LLP 17 State Street, 1911 Floor New York, New York 10004

Re: K052513

Trade/Device Name: Baby Snoopy Water Filled Teether, Model 95367 Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: June 16, 2006 Received: June 19, 2006

Dear Ms. Celis:

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 H (PMA), it may be subject to such 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 Eederal Register.

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## Page 2 - Ms. Celis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Clare

Chiu Lin. Ph.D. 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

K652513 510(k) Number (if known):

Device Name:

Indications for Use:

Water Filled Teether

-User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator -teether then acts as a cold compress for baby's gums and helps reduce the discomfort of teething

Prescription Use_ (Part 21 CFR 801 Subpart D) OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Part 21 CFR 801 Subpart D) OR

Over the Counter Use (21 CFR 801 Subpart C)

Susan Dunn

esiblogy, General Hospital ntrul. Dental Devices

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