The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Nu-cap Calcium Hydrox. Pulp Capping.
| Device ID | K831575 |
| 510k Number | K831575 |
| Device Name: | NU-CAP CALCIUM HYDROX. PULP CAPPING |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | COE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-06-30 |