FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
GR-14 Resin System
K Number: K210298
·
Decision May 5, 2021
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
4
Review Days
91
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Basic Information
- Device Name
- GR-14 Resin System
- K Number
- K210298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pro3Dure Medical GmbH
- Date Received
- February 3, 2021
- Decision Date
- May 5, 2021
- Product Code
- EBI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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