The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Pit & Fissure Sealant With Fluoride.
| Device ID | K031811 |
| 510k Number | K031811 |
| Device Name: | PIT & FISSURE SEALANT WITH FLUORIDE |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Mildred M Goldstein |
| Correspondent | Mildred M Goldstein HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021531 | K031811 | 000 |