The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Durafill Bond.
| Device ID | K921701 |
| 510k Number | K921701 |
| Device Name: | DURAFILL BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-06-09 |