PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement— 510(k) K152652
Substantially EquivalentGaia Dental Products, Inc.
FDA 510(k) clearance K152652 for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement, Substantially Equivalent on 2016-04-05. Applicant: Gaia Dental Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Gaia Dental Products, 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
- Meriden, CT, US
Recent devices under product code EMA
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