Medical Device Manufacturer · US , Appollo Beach , FL

Thermoelastic Technologies, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2000

Recent clearances: BITEM LOCK, MODELS SW006, SW012

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Thermoelastic Technologies, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Nov 14, 2001

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

Cleared Mar 14, 2000

BITEM LOCK, MODELS SW006, SW012

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 11, 2026