The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diaetch Economic Package Type A, Diatech Regular Package, Diaetch Refill Package Type A, Diaetch Intro Kit.
| Device ID | K192273 |
| 510k Number | K192273 |
| Device Name: | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, KR 28161 |
| Contact | Kab Sun Lee |
| Correspondent | Kab Sun Lee Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, KR 28161 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383565196 | K192273 | 000 |
| 08806383565172 | K192273 | 000 |
| 08806383565158 | K192273 | 000 |