The following data is part of a premarket notification filed by Dentalez, Inc. with the FDA for Sd500 Elite Lubefree High Speed Handpiece, Sd500 Elite Lubricated High Speed Handpiece, Sd500 Pro Lubefree High Speed Handpiece, Pro Lubricated High Speed Handpiece.
| Device ID | K192412 |
| 510k Number | K192412 |
| Device Name: | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DentalEZ, Inc. 1816 Colonial Village Lane Lancaster, PA 17601 |
| Contact | Robert Young |
| Correspondent | Robert Young DentalEZ, Inc. 1816 Colonial Village Lane Lancaster, PA 17601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022660720 | K192412 | 000 |
| D7022662600 | K192412 | 000 |
| D7022662750 | K192412 | 000 |
| D7022662760 | K192412 | 000 |
| D7022660400 | K192412 | 000 |
| D7022660410 | K192412 | 000 |
| D7022660640 | K192412 | 000 |
| D7022660650 | K192412 | 000 |
| D7022660710 | K192412 | 000 |
| D7022662450 | K192412 | 000 |