K984508 is an FDA 510(k) clearance for the SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD. This device is classified as a Drill, Dental, Intraoral (Class I - General Controls, product code DZA).
Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 25, 1999, 189 days after receiving the submission on December 18, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4130.
| 510(k) Number | K984508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1998 |
| Decision Date | June 25, 1999 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZA - Drill, Dental, Intraoral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4130 |