510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994357Substantially Equivalent

Bitem Lock, Models Sw006, Sw012

Thermoelastic Technologies, Inc., New Port Riche FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994357 is the FDA 510(k) clearance record for BITEM LOCK, MODELS SW006, SW012, a class I device, cleared for Thermoelastic Technologies, Inc. on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list 2 510(k) clearances for Thermoelastic Technologies, Inc., from to . As of , FDA records show no recalls naming K994357.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Thermoelastic Technologies, Inc. 3234 Ella Ln., New Port Riche FL
510(k) summary
Summary
Third party review
No

Clearances, product code EJF

Trailing 12 months

FDA records hold no clearances under product code EJF in the trailing twelve months.

FDA records show no clearances under product code EJF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260