Data / Medical devices / United States / Dentalez Of Alabama
Dentalez Of Alabama: FDA-registered device maker in Bay Minette, AL, United States, 1 510(k) clearance
Dentalez Of Alabama is registered with the FDA (registration 1049061) in Bay Minette, AL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 8, 1993. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1049061
- Address
- 2500 U.S. Highway 31 South, Bay Minette, AL, United States, 36507
- Owner or operator
- DENTALEZ, INC. (2513147)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- September 30, 1992
- Registered through
- 2027
- Brand names listed
- Barracuda CV-101, Barracuda CV-102, Barracuda MC-201, Barracuda MC-202, CORE Chair, CORE Delivery Unit, CORE Light, Galaxy Delivery Unit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 1993 | K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | EIA | Substantially Equivalent | Den-Tal-Ez Mfg Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental, Accessories
- All makers of Unit, Operative Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of Light, Operating, Dental
Updated July 8, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.