FDA Registration
Active
🇺🇸 United States
DMG America LLC
Reg #: 2244812
·
FEI: 2244812
·
Expires 2026
Products
11
Proprietary Names
18
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- DMG America LLC
- Registration Number
- 2244812
- FEI Number
- 2244812
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 242 S Dean St
- City
- ENGLEWOOD
- State
- NJ
- ZIP
- 07631
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131248
Owner / Operator
- Firm Name
- DMG America, L.L.C.
- Operator Number
- 2244812
- Address
- 242 SOUTH DEAN ST., --
- City
- Englewood
- State
- NJ
- Postal Code
- 07631
- Country
- US
- Correspondent
- George - Wolfe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Post, Root Canal | ELR | Class 1 | Dental | No | 2022-10-26 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2015-01-21 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 1996-05-07 |
| Material, Impression | ELW | Class 2 | Dental | No | 2016-11-14 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2013-12-03 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2008-01-28 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2019-01-11 |
| Alloy, Amalgam | EJJ | Class 2 | Dental | No | 2014-12-16 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2006-11-30 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-07-05 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2008-04-22 |
Proprietary Names
Spirapost PFS Parallel Refill Package (10 Parallel Posts, 1 #5 Gates Glidden)
Agent, Tooth Bonding, Resin
Applicator, Resin - DR. I.B. BIDERMAN'S BEND IT ANY W
Material, Impression
Amalgamator, Dental, AC-Powered - Zenith
Varnish, Cavity - Kolorz
Syringe, Restorative And Impression Material - DMG Composite Dispenser
Alloy, Amalgam
Agent, Polishing, Abrasive, Oral Cavity - Kolorz
Temp Tabs
Spirapost-Parallel Posts
Post, Root Canal - SPIRAPOST PFS
Spirapost PFS Introductory Package
Spirapost-Tapered Posts
Zekrya Large Arc
Protector, Dental - Zekrya Gingival Protector
Zekrya Gingival Protector Kit
Zekrya Small Arc
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)