FLUID FILLED TEETHER - GEL

K092025 · Kids II · KKO · Jan 27, 2011 · Dental

Device Facts

• Record ID: K092025
• Device Name: FLUID FILLED TEETHER - GEL
• Applicant: Kids II
• Product Code: KKO · Dental
• Decision Date: Jan 27, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Teether acts as an aid in relieving an infant's gums due to teething.

Device Story

Fluid-filled gel teether designed to provide relief for infant teething gums. Device is intended for over-the-counter use by caregivers for infants. Teether is freezer safe; requires cleaning with damp cloth and mild soap. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Fluid-filled gel teething ring. Class II device (21 CFR 872.5550). Product code KKO.

Indications for Use

Indicated for infants to provide relief for gums during 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)

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

Mr. Bob Coughlin Kids II 555 North Point Center Suite 600 Alpharetta, Georgia 30022

Re: K092025

Fluid Filled Teether-Gel Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: Class II Product Code: KKO Dated: December 6, 2010 Received: December 6, 2010

JAN 2 7 2511

Dear Mr. Coughlin:

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. 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.

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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,

Wh for

Anthony Watson, MS, MBA Division 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

JAN 2 7 2011

510(k) Number (if known):

K092025

Device Name: Fluid Filled Teether - Gel

Indications For Use:

All teethers instruct consumer to: .

- Clean before use with a damp cloth and mild soap. Air dry. o
- o Not dishwasher safe
- Freezer safe ◆

Teether acts as an aid in relieving an infant's gums due to teething. .

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quaos

Division Sign-Off) Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices ാസ്ട്രീംസ് of Antonol, Dental Devices

§10(k) Number: K062025