ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E— 510(k) K101485
Substantially EquivalentBisco, Inc.
FDA 510(k) clearance K101485 for ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E, Substantially Equivalent on 2010-08-26. Applicant: Bisco, Inc.. Device class: 2.
Clearance details
- Applicant
- Bisco, Inc.
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
Recent devices under product code KLE
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