Dentalez Group: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Dentalez Group” (first 1988, latest 2003), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| EIA | Unit, Operative Dental | 2 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
Review panels
Most recent Dentalez Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | EBF | 2003-04-29 | 105 |
| K021378 | PORTABLE HDX INTRAORAL X-RAY | EHD | 2002-06-07 | 37 |
| K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | EIA | 1999-05-28 | 74 |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | EGS | 1999-01-08 | 87 |
| K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | EFB | 1998-10-22 | 90 |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | EFA | 1996-03-28 | 36 |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | EFA | 1996-03-28 | 52 |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | EFA | 1996-03-28 | 70 |
| K925567 | E 4000 DENTAL OPERATING CHAIR | KLC | 1994-03-10 | 492 |
| K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE | EIA | 1994-01-21 | 324 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentalez Group.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dentalez, Inc. (7 510(k)s)
- Dentalez Group, Stardental Division (2 510(k)s)
- Dentalez, Inc., Stardental Division (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dentalez Group?
FDA lists 13 510(k) clearances under the applicant name “Dentalez Group” (first 1988, latest 2003), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dentalez Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentalez Group is 87 days.
Which FDA product codes appear under Dentalez Group?
The most frequent FDA product codes under this applicant name are EFA (Handpiece, Belt And/Or Gear Driven, Dental, 3); EBF (Material, Tooth Shade, Resin, 2); EFB (Handpiece, Air-Powered, Dental, 2).
Next steps
- See all 13 Dentalez Group clearances with predicates and recalls
- Run predicate analysis for product code EFA, Dentalez Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.