The following data is part of a premarket notification filed by Constancy Ent., Inc. with the FDA for Dental Kit.
| Device ID | K945815 |
| 510k Number | K945815 |
| Device Name: | DENTAL KIT |
| Classification | Burnisher, Operative |
| Applicant | CONSTANCY ENT., INC. 5952 DEL LOMA AVE. San Gabriel, CA 91775 |
| Contact | Tim Yeung |
| Correspondent | Tim Yeung CONSTANCY ENT., INC. 5952 DEL LOMA AVE. San Gabriel, CA 91775 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-07-19 |