510(k) K002469
K002469 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)". The FDA issued a decision of Substantially Equivalent on February 7, 2001. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2001
- Date Received
- August 11, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type