The following data is part of a premarket notification filed by Innovators, Inc. with the FDA for Klip-lite.
| Device ID | K790984 |
| 510k Number | K790984 |
| Device Name: | KLIP-LITE |
| Classification | Light, Operating, Dental |
| Applicant | INNOVATORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-25 |
| Decision Date | 1979-10-22 |