The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Sodium Hypochlorite Solution.
| Device ID | K962743 |
| 510k Number | K962743 |
| Device Name: | PULPDENT SODIUM HYPOCHLORITE SOLUTION |
| Classification | Cleanser, Root Canal |
| Applicant | PULPDENT CORP. 80 OAKLAND ST. Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORP. 80 OAKLAND ST. Watertown, MA 02472 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1996-08-06 |
| Summary: | summary |