FDA · official record K994357Substantially Equivalent

BITEM LOCK, MODELS SW006, SW012

Name: BITEM LOCK, MODELS SW006, SW012 — FDA K994357
Creator: Thermoelastic Technologies, Inc.
Keywords: BITEM LOCK, MODELS SW006, SW012, BITEM LOCK, MODELS SW006, SW012, K994357, EJF, FDA

United StatesEJFThermoelastic Technologies, Inc.

Verified

Official record identity

FDA application number: K994357
Decision date: March 14, 2000
Published decision: Substantially Equivalent

Classification

Product code: EJF

Published parties

Applicant: Thermoelastic Technologies, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-12-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5410

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.