Company ยท US
Dentalez, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2020. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 6, 2020 | K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Ha Dentalez, Inc. | EFB |
| Mar 28, 2018 | K173465 | Concentrix MX-AC High-Speed Handpiece Dentalez, Inc. | EFB |
| Jan 19, 2017 | K162397 | Titan 3 Low Speed Angle Attachments Dentalez, Inc. | EGS |
| Apr 8, 2016 | K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece Dentalez, Inc. | EFB |
| Jan 23, 2012 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES Dentalez, Inc. | EFB |
| Dec 28, 2009 | K093072 | STARCARE HANDPIECE MAINTENANCE UNIT Dentalez, Inc. | EFB |
| Jun 15, 2007 | K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 Dentalez, Inc. | EFB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||