Who is the manufacturer of SOOTHING WATER-FILLED TEETHER?

Consolidated Stores Corp. submitted the Traditional clearance for SOOTHING WATER-FILLED TEETHER (K965082).

What is the FDA product code for SOOTHING WATER-FILLED TEETHER?

KKO. It is classified under 21 CFR 872.5550 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SOOTHING WATER-FILLED TEETHER?

510(k) clearance (submission type: Traditional).

SOOTHING WATER-FILLED TEETHER

K965082 · Consolidated Stores Corp. · KKO · Mar 11, 1997 · Dental

Device Facts

Record ID	K965082
Device Name	SOOTHING WATER-FILLED TEETHER
Applicant	Consolidated Stores Corp.
Product Code	KKO · Dental
Decision Date	Mar 11, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5550
Device Class	Class 2

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.