K042266 is an FDA 510(k) clearance for the ACCLAIM. This device is classified as a Unit, Operative Dental, Accessories (Class I - General Controls, product code NRD).
Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on August 31, 2004, 8 days after receiving the submission on August 23, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640. 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..
| 510(k) Number | K042266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2004 |
| Decision Date | August 31, 2004 |
| Days to Decision | 8 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | NRD - Unit, Operative Dental, Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |
| Definition | 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. |