Medical Device Manufacturer · US , Appollo Beach , FL

Thermoelastic Technologies, Inc.

2 submissions · 2 cleared · Since 2000

Total

Cleared

Denied

Thermoelastic Technologies, Inc. — FDA 510(k) Submissions

Thermoelastic Technologies, Inc. has submitted 2 FDA 510(k) premarket notifications since 2000, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Resin, Denture, Relining, Repairing, Rebasing, Bracket, Metal, Orthodontic . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

K012882 · EBI Resin, Denture, Relining,... · Dental

Nov 2001 78d

BITEM LOCK, MODELS SW006, SW012

K994357 · EJF Bracket, Metal, Orthodontic · Dental

Mar 2000 78d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Thermoelastic Technologies, Inc.

Thermoelastic Technologies, Inc. — FDA 510(k) Submissions

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