The following data is part of a premarket notification filed by Sangi Co, Ltd with the FDA for Apapro Desensitizer.
| Device ID | K220419 |
| 510k Number | K220419 |
| Device Name: | Apapro Desensitizer |
| Classification | Varnish, Cavity |
| Applicant | Sangi Co, Ltd 3-11-6 Tsukiji, Chuo-ku Tokyo, JP 104-8440 |
| Contact | Douglas Mercadante |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-02-16 |