PREMIER SELF-ETCHING ENAMEL SEALANT— 510(k) K061997
Substantially EquivalentPremier Dental Products Co.
FDA 510(k) clearance K061997 for PREMIER SELF-ETCHING ENAMEL SEALANT, Substantially Equivalent on 2006-10-04. Applicant: Premier Dental Products Co.. Device class: 2.
Clearance details
- Applicant
- Premier Dental Products Co.
- 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
- Plymouth Meeting, PA, US
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