The following data is part of a premarket notification filed by Remedent Nv with the FDA for Remecure Model Cl 15e.
| Device ID | K023652 |
| 510k Number | K023652 |
| Device Name: | REMECURE MODEL CL 15E |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | REMEDENT NV 20992 BAKE PKWY. UNIT 102 Lake Forest, CA 92692 |
| Contact | Ed First |
| Correspondent | Ed First REMEDENT NV 20992 BAKE PKWY. UNIT 102 Lake Forest, CA 92692 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2003-01-09 |