The following data is part of a premarket notification filed by J. Aderer, Inc. with the FDA for Sr-ivocap.
Device ID | K810687 |
510k Number | K810687 |
Device Name: | SR-IVOCAP |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | J. ADERER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-13 |
Decision Date | 1981-04-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SR-IVOCAP 73261259 1250192 Live/Registered |
Ivoclar AG 1980-05-08 |