510(k) K042266
K042266 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "ACCLAIM". The FDA issued a decision of Substantially Equivalent on August 31, 2004. The device falls under product code NRD (Unit, Operative Dental, Accessories), a Class I device regulated under 21 CFR 872.6640. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.
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.