510(k) K881974
K881974 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "PROFICIENT(TM) PROPHYLAXIS ANGLE". The FDA issued a decision of Substantially Equivalent on July 25, 1988. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1988
- Date Received
- May 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type