Dentalez, Inc.: FDA clearances and approvals
Dentalez, Inc. has 7 FDA 510(k) clearances (first 2007, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 124 days. Since 2017 its median was 140 days, against 241 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 76 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 135 |
| 2017 | 1 | 146 |
| 2018 | 1 | 140 |
| 2019 | 0 | — |
| 2020 | 1 | 124 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dentalez, Inc.'s cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 241 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 6 | 6 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
Review panels
- Dental (7)
Most recent Dentalez, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | EFB | 2020-01-06 | 124 |
| K173465 | Concentrix MX-AC High-Speed Handpiece | EFB | 2018-03-28 | 140 |
| K162397 | Titan 3 Low Speed Angle Attachments | EGS | 2017-01-19 | 146 |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | EFB | 2016-04-08 | 135 |
| K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | EFB | 2012-01-23 | 76 |
| K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | EFB | 2009-12-28 | 89 |
| K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | EFB | 2007-06-15 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Dentalez, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dentalez, Inc. have?
Dentalez, Inc. has 7 FDA 510(k) clearances (first 2007, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear Dentalez, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dentalez, Inc.'s cleared 510(k)s is 124 days. Since 2017: 140 days, versus 241 days for all cleared 510(k)s in the same product codes.
What devices does Dentalez, Inc. make?
Its most frequent FDA product codes are EFB (Handpiece, Air-Powered, Dental, 6); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 1).
Has Dentalez, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dentalez, Inc. Related entities may recall under other names.
Next steps
- See all 7 Dentalez, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Dentalez, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.