CALSET COMPOSITE HEATER— 510(k) K061395
Substantially EquivalentAddent, Inc.
FDA 510(k) clearance K061395 for CALSET COMPOSITE HEATER, Substantially Equivalent on 2006-06-23. Applicant: Addent, Inc.. Device class: 2.
Clearance details
- Applicant
- Addent, Inc.
- Product code
- Code EBZ
- Device class
- Class 2
- Regulation
- 21 CFR 872.6070
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danbury, CT, US
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