Data / Medical devices / United States / DMG America LLC
DMG America LLC: FDA-registered device maker in Englewood, NJ, United States, 8 510(k) clearances
DMG America LLC is registered with the FDA (registration 2244812) in Englewood, NJ, United States. It lists 11 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 11, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2244812
- Address
- 242 S Dean St, Englewood, NJ, United States, 07631
- Owner or operator
- DMG America, L.L.C. (2244812)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 7, 1996
- Registered through
- 2026
- Brand names listed
- Agent, Polishing, Abrasive, Oral Cavity - Kolorz, Agent, Tooth Bonding, Resin, Alloy, Amalgam, Amalgamator, Dental, AC-Powered - Zenith, Applicator, Resin - DR. I.B. BIDERMAN'S BEND IT ANY W, Material, Impression, Post, Root Canal - SPIRAPOST PFS, Protector, Dental - Zekrya Gingival Protector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Amalgam | EJJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Amalgamator, Dental, Ac-Powered | EFD | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Repackager or relabeler | 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 11, 2013 | K131248 | ETCH GEL | KLE | Substantially Equivalent | Dmg America, LLC | accessdata.fda.gov |
| March 30, 2006 | K060075 | FIBER-METAL POST | ELR | Substantially Equivalent | Foremost Dental, LLC | accessdata.fda.gov |
| February 4, 2004 | K040098 | VARNISHAMERICA | LBH | Substantially Equivalent | Medical Products Laboratories, Inc. | accessdata.fda.gov |
| January 16, 2004 | K033227 | LUXAFORM PLUS | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| October 22, 2001 | K013237 | STATUSBLUE | ELW | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| May 25, 1995 | K951865 | ULTRA SPHERICAL AMALGAM ALLOY | EJJ | Substantially Equivalent | Goldsmith & Revere, Inc. | accessdata.fda.gov |
| May 24, 1982 | K821222 | GOLDSMITH & REVERE TENARY ALLOY | EJJ | Substantially Equivalent | Goldsmith & Revere, Inc. | accessdata.fda.gov |
| March 25, 1982 | K820617 | DISPERSED PHASE ALLOY | EJJ | Substantially Equivalent | Goldsmith & Revere, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Alloy, Amalgam
- All makers of Syringe, Restorative And Impression Material
- All makers of Applicator, Resin
- All makers of Agent, Tooth Bonding, Resin
- All makers of Amalgamator, Dental, Ac-Powered
- All makers of Protector, Dental
Updated July 11, 2013. 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.