510(k) K170261
K170261 is an FDA 510(k) premarket notification submitted by Premium Plus International Limited for the device "Premium Plus Prophy Air Motor". The FDA issued a decision of Substantially Equivalent on October 19, 2017. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Premium Plus International Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2017
- Date Received
- January 27, 2017
- Clearance Type
- Abbreviated
- 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