BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060— 510(k) K012882
Substantially EquivalentThermoelastic 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..
Clearance details
- Applicant
- Thermoelastic Technologies, Inc.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Appollo Beach, FL, US
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.