FDA · official record K091198Substantially Equivalent

LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING

Name: LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING — FDA K091198
Creator: Allied Hill Enterprises, Ltd.
Keywords: LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING, LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING, K091198, KKO, FDA

United StatesKKOAllied Hill Enterprises, Ltd.

Verified

Official record identity

FDA application number: K091198
Decision date: December 07, 2009
Published decision: Substantially Equivalent

Classification

Product code: KKO

Published parties

Applicant: Allied Hill Enterprises, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-04-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5550

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.