Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2244812

FEI Number

2244812

Entity Name

DMG America LLC

City/State/Country

ENGLEWOOD, NJ, US

Establishment Address

242 S Dean St, ENGLEWOOD, NJ 07631, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DMG America, L.L.C. (Owner Number: 2244812)

Owner / Operator Contact Address

242 SOUTH DEAN ST., --, Englewood, NJ 07631, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K820617

PMA Number

N/A

All Registered 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 Alloy, Amalgam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELR	Post, Root Canal	Dental	Class 1	872.3810	2022-10-26
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-01-21
KXR	Applicator, Resin	Dental	Class 1	872.3140	1996-05-07
ELW	Material, Impression	Dental	Class 2	872.3660	2016-11-14
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2013-12-03
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-01-28
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2019-01-11
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2014-12-16
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2006-11-30
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-07-05
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2014-12-16

Official Correspondent

George Wolfe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DMG America, L.L.C.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

Registration Number	Establishment Name	Location
3023852420	Hipp Medical AG	Renquishausen Baden-Wurttemberg, DE
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3043648115	DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD.	Shijiazhuang Hebei, CN
3011713204	Henan Lusterdent Medical Instrument Co.,Ltd	Zhengzhou Henan, CN
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2244812. Last updated year: 2026. Please use registration number 2244812 when referencing this establishment in official correspondence.