The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Spectrum Curing Light Polymerization Unit.
| Device ID | K951425 |
| 510k Number | K951425 |
| Device Name: | SPECTRUM CURING LIGHT POLYMERIZATION UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | P. J Lehn |
| Correspondent | P. J Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026446571 | K951425 | 000 |
| D0026446561 | K951425 | 000 |