GEL FILLED GUM SOOTHER

K092494 · Luv N' Care, Ltd. · KKO · Mar 1, 2010 · Dental

Device Facts

• Record ID: K092494
• Device Name: GEL FILLED GUM SOOTHER
• Applicant: Luv N' Care, Ltd.
• Product Code: KKO · Dental
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.

Device Story

Teething ring filled with water or gel; designed for infants/children to chew on; provides cooling sensation to gums; intended for over-the-counter use; non-powered, mechanical device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Water or gel-filled ring; non-powered; mechanical design; intended for oral use.

Indications for Use

Indicated for teething children to provide a soothing, cooling effect on gums during chewing.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Joseph H. Hakim President Luv n' care. Limited 3030 Aurora Avenue Monroe, Louisiana 71211

MAR - 1 2010

Re: K092494

Trade/Device Name: Teething Ring - Water or Gel Filled Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: February 17, 2010 Received: February 17, 2010

Dear Mr. Hakim:

We have reviewed your Section 310(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.

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Page 2- Mr. Hakim

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 /ucm 1 1 5809.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/defaul t.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,

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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| | INDICATIONS FOR USE |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | K 092494 |
| 510(k) Number: | (Submitted) - K092494 |
| Device Name: | Teething Ring – Water or Gel Filled |
| Indications For Use: | |
| | The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) |
| | Concurrence of DRRH, Office of Device Evaluation (ODE) |
| Prescription Use | OR Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| | R.B.Betz DDS for Dr. K.P. Mabry |
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
| 510(k) Number: | K092494 |

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