The following data is part of a premarket notification filed by Dentsply International with the FDA for Ptm System.
| Device ID | K041335 |
| 510k Number | K041335 |
| Device Name: | PTM SYSTEM |
| Classification | Powder, Porcelain |
| Applicant | DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17405 |
| Contact | P Jeffery Lehn |
| Correspondent | P Jeffery Lehn DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17405 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-18 |
| Decision Date | 2004-06-16 |
| Summary: | summary |