DURASHIELD PLUS— 510(k) K082198
Substantially EquivalentDentsply Intl., Inc.
FDA 510(k) clearance K082198 for DURASHIELD PLUS, Substantially Equivalent on 2008-10-29. Applicant: Dentsply Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dentsply Intl., Inc.
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
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