The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Soft Denture Reline Material Elastoline.
| Device ID | K925275 |
| 510k Number | K925275 |
| Device Name: | SOFT DENTURE RELINE MATERIAL ELASTOLINE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Contact | Stephen P Warunek |
| Correspondent | Stephen P Warunek GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-20 |
| Decision Date | 1993-01-11 |