Dentamerica
City of Industry, CA, US
DENTAMERICA appears in FDA device records in City of Industry, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Dentamerica between 1996 and 2010. The busiest year on record is 1996, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 2006 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | EKX | Substantially Equivalent | |
| K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | EHD | Substantially Equivalent | |
| K954820 | SCALEX 800 | ELC | Substantially Equivalent | |
| K955759 | LITEX 680 | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2024949 | 2024949 | DENTAMERICA | 18688 SAN JOSE AVE, City of Industry, CA 91748 US | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- EHAAligner, Beam, X-Ray
- EJLBur, Dental
- KQMCamera, Surgical And Accessories
- EHKCup, Prophylaxis
- EKSFile, Pulp Canal, Endodontic
- IWZFilm, Radiographic
- EKXHandpiece, Direct Drive, Ac-Powered
- EEGHeat Source For Bleaching Teeth
- EGZHolder, Film, X-Ray
- IXCIlluminator, Radiographic-Film
- ELAInstrument, Hand, Calculus Removal
- EAYLight, Fiber Optic, Dental
- EAZLight, Operating, Dental
- ELWMaterial, Impression
- EAXMirror, Mouth
- JEPRetainer, Matrix
- EIGRetractor, All Types
- ELCScaler, Ultrasonic
- MUHSystem, X-Ray, Extraoral Source, Digital
- EHYTray, Impression, Preformed
- NRDUnit, Operative Dental, Accessories
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain