510(k) K083811
K083811 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "W&H HANDPIECE ANESTO, MODEL: RA-5". The FDA issued a decision of Substantially Equivalent on January 14, 2010. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2010
- Date Received
- December 22, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Jet, Mechanical-Powered
- Device Class
- Class II
- Regulation Number
- 872.4475
- Review Panel
- DE
- Submission Type