PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT— 510(k) K012761
Substantially EquivalentPrime Dental Manufacturing, Inc.
FDA 510(k) clearance K012761 for PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT, Substantially Equivalent on 2001-11-01. Applicant: Prime Dental Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Prime Dental Manufacturing, Inc.
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code EBC
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