510(k) K190508
K190508 is an FDA 510(k) premarket notification submitted by Ttbio Corp. for the device "EVO 450 series High Speed Handpieces". The FDA issued a decision of Substantially Equivalent on December 11, 2019. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Ttbio Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2019
- Date Received
- March 1, 2019
- 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