BITEM LOCK, MODELS SW006, SW012— 510(k) K994357

Name: FDA 510(k) clearance K994357
Creator: U.S. Food and Drug Administration
Published: 2000-03-14

Substantially Equivalent

Thermoelastic Technologies, Inc.

FDA 510(k) clearance K994357 for BITEM LOCK, MODELS SW006, SW012, Substantially Equivalent on 2000-03-14. Applicant: Thermoelastic Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Thermoelastic Technologies, Inc.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1999-12-27
Decision date: 2000-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Riche, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

view all

K932825 — MICROARCH GOLD BRACKET1994-05-09
K933501 — ALASTIK1994-04-28
K923372 — MEMORY WIRE1994-04-22
K933080 — ORTHOTECH DURA-GOLD BARCKETS1994-03-23
K935139 — FASCINATION CERAMIC BRACKET1994-02-04

More clearances from Thermoelastic Technologies, Inc.

view all

K012882 — BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 1200602001-11-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.