The following data is part of a premarket notification filed by Ttbio Corp. with the FDA for Evo 500 Series High Speed Handpieces/tiger 500/300/101 Series High Speed Handpieces.
| Device ID | K141183 |
| 510k Number | K141183 |
| Device Name: | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK Taichung, Roc, TW 40755 |
| Contact | Shu-ching Lee |
| Correspondent | Shu-ching Lee TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK Taichung, Roc, TW 40755 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-07 |
| Decision Date | 2015-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040063542 | K141183 | 000 |
| 10304040063528 | K141183 | 000 |
| 00304040062098 | K141183 | 000 |
| 00304040062081 | K141183 | 000 |
| 00304040062029 | K141183 | 000 |
| 00304040062012 | K141183 | 000 |