The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Fiber Optic Handpiece.
| Device ID | K780483 |
| 510k Number | K780483 |
| Device Name: | FIBER OPTIC HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SYNTEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-27 |
| Decision Date | 1978-04-28 |