PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT— 510(k) K112574
Substantially EquivalentPrime Dental Manufacturing, Inc.
FDA 510(k) clearance K112574 for PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT, Substantially Equivalent on 2012-01-23. Applicant: Prime Dental Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Prime Dental Manufacturing, Inc.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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