510(k) K213201
K213201 is an FDA 510(k) premarket notification submitted by DMG Chemisch-Pharmazeutische Fabrik GmbH for the device "DeltaFil, DeltaFil Conditioner". The FDA issued a decision of Substantially Equivalent on Jun 1, 2022. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. DMG Chemisch-Pharmazeutische Fabrik GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2022
- Date Received
- Sep 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)