The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Shur Gel.
| Device ID | K830083 |
| 510k Number | K830083 |
| Device Name: | SHUR GEL |
| Classification | Material, Impression |
| Applicant | COLUMBUS DENTAL MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-02-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHUR GEL 74576685 1967865 Dead/Cancelled |
MILES INC. 1994-09-22 |