The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Calcium Hydroxide Medicament.
| Device ID | K964191 |
| 510k Number | K964191 |
| Device Name: | CALCIUM HYDROXIDE MEDICAMENT |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | William R Pike |
| Correspondent | William R Pike SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-01-22 |