The following data is part of a premarket notification filed by Guangzhou Heygears Imc. Inc with the FDA for Ultraprint-dental Temp C&b Uv.
| Device ID | K213643 |
| 510k Number | K213643 |
| Device Name: | UltraPrint-Dental Temp C&B UV |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Guangzhou Heygears Imc. Inc Block B2, 501, 601, Enterprise Accelerator, Kaifa District Guangzhou, CN 510700 |
| Contact | Lin Liu |
| Correspondent | Chris Brown Aclivi, LLC 3250 Brackley Drive Ann Arbor, MI 48105 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-18 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971437940440 | K213643 | 000 |
| 06971437940273 | K213643 | 000 |
| 06971437940266 | K213643 | 000 |
| 06971437940259 | K213643 | 000 |
| 06971437940242 | K213643 | 000 |
| 06971437940129 | K213643 | 000 |
| 06971437940068 | K213643 | 000 |
| 06971437940044 | K213643 | 000 |
| 06971437940600 | K213643 | 000 |
| 06971437940594 | K213643 | 000 |
| 06971437940587 | K213643 | 000 |
| 06971437940570 | K213643 | 000 |
| 06971437940563 | K213643 | 000 |
| 06971437940556 | K213643 | 000 |
| 06971437940549 | K213643 | 000 |
| 06971437940280 | K213643 | 000 |
| 06971437940297 | K213643 | 000 |
| 06971437940433 | K213643 | 000 |
| 06971437940426 | K213643 | 000 |
| 06971437940419 | K213643 | 000 |
| 06971437940402 | K213643 | 000 |
| 06971437940396 | K213643 | 000 |
| 06971437940389 | K213643 | 000 |
| 06971437940372 | K213643 | 000 |
| 06971437940365 | K213643 | 000 |
| 06971437940358 | K213643 | 000 |
| 06971437940341 | K213643 | 000 |
| 06971437940334 | K213643 | 000 |
| 06971437940327 | K213643 | 000 |
| 06971437940310 | K213643 | 000 |
| 06971437940303 | K213643 | 000 |
| 06971437940532 | K213643 | 000 |