Data / Medical devices / United States / Army Dental Laboratory
Army Dental Laboratory: FDA-registered device maker in Fort Eisenhower, GA, United States, 2 510(k) clearances
Army Dental Laboratory is registered with the FDA (registration 3005597557) in Fort Eisenhower, GA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 1, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005597557
- Address
- Bldg 322 East Hospital Road, Fort Eisenhower, GA, United States, 30905
- Owner or operator
- Army Dental Laboratory (10078655)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 30, 2020
- Registered through
- 2027
- Brand names listed
- Coritec 350i Loader Pro, abutment, implant, dental, endosseous, biodenta customized abutment - hybrid, biodenta customized abutment - titanium, coritec
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 1, 2022 | K222368 | MIST IC | NHA | Substantially Equivalent | Imagine Milling Technologies, LLC | accessdata.fda.gov |
| April 16, 2019 | K182246 | MIST IC | NHA | Substantially Equivalent | Imagine Milling Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 1, 2022. 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.