The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Delton Light Curing Pit & Fissure.
| Device ID | K831380 |
| 510k Number | K831380 |
| Device Name: | DELTON LIGHT CURING PIT & FISSURE |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-28 |
| Decision Date | 1983-06-30 |