510(k) K192830
K192830 is an FDA 510(k) premarket notification submitted by Dmp Dental Industry S.A. for the device "Bright Temporary C&B". The FDA issued a decision of Substantially Equivalent on September 2, 2020. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Dmp Dental Industry S.A. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2020
- Date Received
- October 2, 2019
- 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