The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Gold Link (formerly Den-mat Metal Opaquer).
| Device ID | K860971 |
| 510k Number | K860971 |
| Device Name: | DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Contact | Glace |
| Correspondent | Glace DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-03-25 |