The following data is part of a premarket notification filed by Ttbio Corp. with the FDA for Evo 450 Series High Speed Handpieces.
| Device ID | K190508 |
| 510k Number | K190508 |
| Device Name: | EVO 450 Series High Speed Handpieces |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | TTBIO CORP. 2F, No.7, 6th Road Industry Park Taichung, TW 40755 |
| Contact | Sheng-chieh Su |
| Correspondent | Shu-ching Lee TTBIO CORP. 2F, No.7, 6th Road Industry Park Taichung, TW 40755 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040125687 | K190508 | 000 |
| 00304040125670 | K190508 | 000 |
| 00304040125663 | K190508 | 000 |