510(k) K042266
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2004
- Date Received
- August 23, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental, Accessories
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.