The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Vizilite-blue Oral Exam Kit.
| Device ID | K033033 |
| 510k Number | K033033 |
| Device Name: | VIZILITE-BLUE ORAL EXAM KIT |
| Classification | Light, Operating, Dental |
| 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 | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-09-26 |
| Decision Date | 2004-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8136501991 | K033033 | 000 |
| D8136501060 | K033033 | 000 |