The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Restor (comet)*dental Restorative.
Device ID | K861833 |
510k Number | K861833 |
Device Name: | RESTOR (COMET)*DENTAL RESTORATIVE |
Classification | Material, Tooth Shade, Resin |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
Contact | Landsman, Mhs |
Correspondent | Landsman, Mhs JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-13 |
Decision Date | 1986-07-09 |