The following data is part of a premarket notification filed by Hyunjae Corp. with the FDA for Hyunjae Dental Impression Materials.
| Device ID | K962680 |
| 510k Number | K962680 |
| Device Name: | HYUNJAE DENTAL IMPRESSION MATERIALS |
| Classification | Material, Impression |
| Applicant | HYUNJAE CORP. 8 SOUTH END PLAZA New Milford, CT 06776 |
| Contact | Daniel G Modica |
| Correspondent | Daniel G Modica HYUNJAE CORP. 8 SOUTH END PLAZA New Milford, CT 06776 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-10 |
| Decision Date | 1996-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757L110920 | K962680 | 000 |
| D757L11090P1 | K962680 | 000 |
| D757L31010K1 | K962680 | 000 |
| D757L31010 | K962680 | 000 |