The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Cordless Prosthodontic Screwdriver With Torque Calibration System, Model Isd900.
| Device ID | K110278 |
| 510k Number | K110278 |
| Device Name: | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2012-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264521865 | K110278 | 000 |
| 04560264522336 | K110278 | 000 |
| 04560264576667 | K110278 | 000 |
| 04560264522329 | K110278 | 000 |
| 04560264573291 | K110278 | 000 |
| 04560264574212 | K110278 | 000 |