The following data is part of a premarket notification filed by Lightspeed Endodontics with the FDA for Lightspeed Dental Hand Instrument.
| Device ID | K932529 |
| 510k Number | K932529 |
| Device Name: | LIGHTSPEED DENTAL HAND INSTRUMENT |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | LIGHTSPEED ENDODONTICS 5832 AUDEN Houston, TX 77005 |
| Contact | Steve Senia |
| Correspondent | Steve Senia LIGHTSPEED ENDODONTICS 5832 AUDEN Houston, TX 77005 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-25 |
| Decision Date | 1993-11-04 |