510(k) K960541
K960541 is an FDA 510(k) premarket notification submitted by Mti Precision Products for the device "LYNX DPA DISPOSABLE PROPHY ANGLE". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Mti Precision Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1996
- Date Received
- February 7, 1996
- 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