The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Orallite Comprehensive Exam Tray.
| Device ID | K012070 |
| 510k Number | K012070 |
| Device Name: | ORALLITE COMPREHENSIVE EXAM TRAY |
| Classification | Source, Chemiluminescent Light |
| Applicant | TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Contact | Martin L Lonky |
| Correspondent | Martin L Lonky TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Product Code | MPU |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-11-27 |