The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Speculite/orallite.
| Device ID | K003995 |
| 510k Number | K003995 |
| Device Name: | SPECULITE/ORALLITE |
| Classification | Light, Operating, Dental |
| Applicant | TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Contact | Martin Lonky |
| Correspondent | Martin Lonky TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-03-16 |