510(k) K934981
K934981 is an FDA 510(k) premarket notification submitted by Eare Consulting Service for the device "DENTAL DRILL". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Eare Consulting Service has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1994
- Date Received
- October 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Diamond, Dental
- Device Class
- Class I
- Regulation Number
- 872.4535
- Review Panel
- DE
- Submission Type