The following data is part of a premarket notification filed by Ttbio Corp. with the FDA for Evoclean Cleansert Ultrasonic Insert.
| Device ID | K210832 |
| 510k Number | K210832 |
| Device Name: | EVOCLEAN CLEANsert Ultrasonic Insert |
| Classification | Scaler, Ultrasonic |
| Applicant | TTBIO CORP. 2F, No.7, 6th Road, Industry Park Taichung, TW 40755 |
| Contact | Sheng-chieh Su |
| Correspondent | Shu-hui Lin TTBIO CORP. 2F, No.7, 6th Road, Industry Park Taichung, TW 40755 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2022-02-02 |