OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS— 510(k) K994435
Substantially EquivalentJeneric/Pentron, Inc.
FDA 510(k) clearance K994435 for OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS, Substantially Equivalent on 2000-02-10. Applicant: Jeneric/Pentron, Inc.. Device class: 2.
Clearance details
- Applicant
- Jeneric/Pentron, Inc.
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, US
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