BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060— 510(k) K012882

Name: FDA 510(k) clearance K012882
Creator: U.S. Food and Drug Administration
Published: 2001-11-14

Substantially Equivalent

Thermoelastic Technologies, Inc.

FDA 510(k) clearance K012882 for BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060, Substantially Equivalent on 2001-11-14. Applicant: Thermoelastic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Thermoelastic Technologies, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2001-08-28
Decision date: 2001-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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