The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Surgical Contra-angle Handpieces, Models 975 Ae,979 E/km, 985 Ae, 986 Ae, 988 E/km And Surgical Straight Handpieces Mod.
| Device ID | K984508 |
| 510k Number | K984508 |
| Device Name: | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD |
| Classification | Drill, Dental, Intraoral |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE A-5111 Buermoos, AT 5111 |
| Contact | Herbert Traschwandtner |
| Correspondent | Herbert Traschwandtner W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE A-5111 Buermoos, AT 5111 |
| Product Code | DZA |
| CFR Regulation Number | 872.4130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-18 |
| Decision Date | 1999-06-25 |