Clearance Summary
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD received FDA 510(k) clearance under submission number K984508, sponsored by W&H Dentalwerk Buermoos GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-06-25.
- Submission: K984508
- Applicant / Sponsor: W&H Dentalwerk Buermoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4130
- Decision date: 1999-06-25
Classification & Regulation
This clearance is catalogued under FDA product code DZA and 21 CFR 872.4130, within the Dental review panel as a Class I device.