The following data is part of a premarket notification filed by Zhermack Dental Production with the FDA for Indurent Gel.
| Device ID | K935892 |
| 510k Number | K935892 |
| Device Name: | INDURENT GEL |
| Classification | Material, Impression |
| Applicant | ZHERMACK DENTAL PRODUCTION 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan C Dick, Ph.d. |
| Correspondent | Evan C Dick, Ph.d. ZHERMACK DENTAL PRODUCTION 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1995-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 68033712561150 | K935892 | 000 |