The following data is part of a premarket notification filed by J. Aderer, Inc. with the FDA for Sr-ivolen.
| Device ID | K810686 |
| 510k Number | K810686 |
| Device Name: | SR-IVOLEN |
| Classification | Material, Impression Tray, Resin |
| Applicant | J. ADERER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-13 |
| Decision Date | 1981-04-14 |