BERRY FRUITY TEETHER

K053493 · Evenflo Company, Inc. · KKO · Feb 22, 2006 · Dental

Device Facts

• Record ID: K053493
• Device Name: BERRY FRUITY TEETHER
• Applicant: Evenflo Company, Inc.
• Product Code: KKO · Dental
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.

Device Story

Evenflo Berry Fruity Teether is a personal-use biting device designed to soothe infant gum discomfort during teething. The device is intended to be cooled prior to use to provide a cooling sensation. It is an over-the-counter product intended for use by infants under caregiver supervision. The device functions as a mechanical aid for teething relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Teething ring device; intended for cooling/soothing gums. Class II, Product Code KKO. No specific materials or software described.

Indications for Use

Indicated for infants experiencing teething discomfort to soothe and cool gums via biting.

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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Public Health Service

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FEB 2 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ruben D. Colmenares Product Integrity Engineer Evenflo Company, Incorporated 707 Crossroads Court Vandalia, Ohio 45377

Re: K053493

Trade/Device Name: Evenflo Berry Fruity Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: Class II Product Code: KKO Dated: December 14, 2005 Received: December 16, 2005

Dear Mr. Colmenares:

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 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 Federal Register.

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## Page 2 – Mr. Ruben D. Colmenares

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a substantal species with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that HDA has made a decemination mat your a viser Federal agencies.
of the Act or any Federal statutes and regulations administered by segistration of the Act or any rederal statutes and reginations and limited to: registration
You must comply with all the Act's requirements and manufacturing progrise You must comply with an the Act 3 requirements integral and manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part and listing (21 CFK Fall 807), laboling (21 CFR (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); requirements as set form in the quality systems (Sections 531-542 of the Act);
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 I his letter will anow you to oegh manketing your and stantial equivalence of your device and thus 510(K) premarket nothreation: "The FDT Missing on 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), , If you desire specific advice for your de at [phone]. Also, please note the regulation please contact the Other or Ochipanian promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miromation on Journational and Consumer Assistance at its toll-free Division of Binan 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

053493 510(k) Number (if known): _

Device Name: Evenflo Berry Fruity Teether

Indications for Use:

The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Susa Puono

resistagy, General Hospitz!