The following data is part of a premarket notification filed by Dentall Co., Ltd. with the FDA for Delight, Delight Ortho, B&lite S.
| Device ID | K170529 |
| 510k Number | K170529 |
| Device Name: | Delight, Delight Ortho, B&Lite S |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTALL Co., Ltd. 301-905, Bucheontechnopark, 345, Seokcheon-ro, Ojeong-gu Bucheon-si, KR 14501 |
| Contact | Jonghyuk Lee |
| Correspondent | Dongha Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800096902064 | K170529 | 000 |
| 08800096902057 | K170529 | 000 |
| 08800096902040 | K170529 | 000 |
| 08800096902033 | K170529 | 000 |
| 08800096902026 | K170529 | 000 |
| 08800096902019 | K170529 | 000 |