The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Johnson & Johnson Staining Removing Compound.
| Device ID | K864226 |
| 510k Number | K864226 |
| Device Name: | JOHNSON & JOHNSON STAINING REMOVING COMPOUND |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Contact | Carol E Landsman |
| Correspondent | Carol E Landsman JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1987-05-01 |