510(k) K183337
K183337 is an FDA 510(k) premarket notification submitted by DMG Chemisch-Pharmazeutische Fabrik GmbH for the device "LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. DMG Chemisch-Pharmazeutische Fabrik GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2019
- Date Received
- Dec 3, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
- 510(k)