The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Pharmaethyl Local Pulp And Vitality Testing Agent.
| Device ID | K012427 |
| 510k Number | K012427 |
| Device Name: | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT |
| Classification | Tester, Pulp |
| Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-31 |
| Decision Date | 2001-10-09 |