The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Elan-2.
| Device ID | K983091 |
| 510k Number | K983091 |
| Device Name: | ELAN-2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-03 |
| Decision Date | 1998-10-28 |
| Summary: | summary |