FLUID FILLED TEETHERS

K031094 · Royal King Infant Products Co. , Ltd. · KKO · Dec 8, 2003 · Dental

Device Facts

• Record ID: K031094
• Device Name: FLUID FILLED TEETHERS
• Applicant: Royal King Infant Products Co. , Ltd.
• Product Code: KKO · Dental
• Decision Date: Dec 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

Device Story

Fluid-filled teether designed for infant use; provides cooling relief for teething discomfort. Device is chilled prior to use; infant chews on device to soothe gums. Simple mechanical device; no electronic components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Fluid-filled teething ring; Class I device; non-powered; mechanical design.

Indications for Use

Indicated for infants experiencing teething discomfort to provide a cooling soothing effect 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2003

Mr. Dalbir Singh Khurana President Royal King Infant Products Company Limited 73/4 Moo 1 Khaelie Krathumbae, Samutsakor, THAILAND 74110

Re: K031094

Trade/Device Name: Fluid Filled Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: I Product Code: KKO Dated: September 8, 2003 Received: September 11, 2003

Dear Mr. Khurana:

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 (sec 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. Khurana

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/dsma/dsmamain.html

Sincerely yours,

Susanne Pasu D for Chiu len

Chiu Lin, Ph.D. Director Division of Anesthesiology, General I Iospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Astatement of Indications for use@

**510(k) Number (If Known)**: k031694

Device Name :Fluid Filled Teether

Indications For Use :

The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

(Please do not write below this line-continue on another page if NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------|---------------------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
| 510(k) Number: | IC03)094 |

I'rescription Use ______ OR Over- The Counter Use _✔️_

(Per 21 CFR 801.109) (Optional format 1-2-96)

CI