Manufacturer registered with FDA
DMG America, L.L.C.
Englewood, NJ, United States. Lists 10 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 10
- Brands and models
- 14
- 510(k) clearances
- 12013–2013
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name DMG America, L.L.C. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DMG America, L.L.C. | 1 clearances | 2013–2013 | Below |
| Canada | Health Canada | Registration holder | DMG AMERICA LLC | 3 | 2016–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DMG AMERICA | 2 | 2011–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DMG America LLC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DMG America, L.L.C. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Amalgam AlloyEJJ · Class 2 | — | Maker | Alloy, Amalgam | 2014 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Post, Root Canal - SPIRAPOST PFSSpirapost PFS Introductory PackageSpirapost PFS Parallel Refill Package (10 Parallel Posts, 1 #5 Gates Glidden)Spirapost-Parallel PostsSpirapost-Tapered Posts | 2006 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Temp Tabs | 2022 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Amalgamator, Dental, AC-Powered - Zenith | 2013 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Syringe, Restorative And Impression Material - DMG Composite Dispenser | 2019 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Agent, Polishing, Abrasive, Oral Cavity - Kolorz | 2006 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Material, Impression | 2016 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Agent, Tooth Bonding, Resin | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Applicator, Resin - DR. I.B. BIDERMAN'S BEND IT ANY W | 1996 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | Varnish, Cavity - Kolorz | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DMG America, L.L.C. as the applicant.
Some of these clearances are listed with FDA today by another company: indigodental GmbH (1), DMG Chemisch-Pharmazeutische Fabrik GmbH (1).
Also lists devices cleared under other names
DMG America, L.L.C. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Goldsmith & Revere, Inc. (3), Dmg USA, Inc. (2), Foremost Dental, LLC (1), Medical Products Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Mar 2006 | K060075 | FIBER-METAL POST | Foremost Dental, LLC | ELR Root Canal Post |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 16 Jan 2004 | K033227 | LUXAFORM PLUS | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 22 Oct 2001 | K013237 | STATUSBLUE | Dmg USA, Inc. | ELW Impression Material |
| 25 May 1995 | K951865 | ULTRA SPHERICAL AMALGAM ALLOY | Goldsmith & Revere, Inc. | EJJ Amalgam Alloy |
| 24 May 1982 | K821222 | GOLDSMITH & REVERE TENARY ALLOY | Goldsmith & Revere, Inc. | EJJ Amalgam Alloy |
| 25 Mar 1982 | K820617 | DISPERSED PHASE ALLOY | Goldsmith & Revere, Inc. | EJJ Amalgam Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DMG America LLCFDA reg. 2244812 | ENGLEWOOD, NJ, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2244812). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.