510(k) K191843
K191843 is an FDA 510(k) premarket notification submitted by Amann Girrbach AG for the device "Ceramill A-Temp". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Amann Girrbach AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2019
- Date Received
- July 9, 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