510(k) K901967
K901967 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "DENDIA WERK BURS AND CUTTING DISCS". The FDA issued a decision of Substantially Equivalent on July 13, 1990. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1990
- Date Received
- May 1, 1990
- 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