Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1821514

FEI Number

1821514

Entity Name

KULZER, LLC

City/State/Country

SOUTH BEND, IN, US

Establishment Address

4315 S. Lafayette Blvd., SOUTH BEND, IN 46614, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Kulzer, LLC (Owner Number: 9056636)

Owner / Operator Contact Address

4315 S. Lafayette Blvd., South Bend, IN 46614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgident Periphery Wax Pala Brillance Denture Cleanser Venus Rapid Fresh Cleanser Modern Materials Utility Wax Strips Modern Materials Bite Blocks Modern Materials Square Ropes Utility Square Ropes Modern Materials Yellow Wax Sheets Utility Wax Strips Modern Materials Yellow Check Bite Wafers Surgident COPRWAX Cara Scan 4i Cara Scan 4 BUNDLE Cara Scan 4 Cara i500 IVORY RUBBER DAM CLAMP Ivory Rubber Dam Complete Kit Ivory Rubber Dam Starter Kit IVORY RUBBER DAM INTRO KIT Ivory Ivory Rubber Dam Frame iCEM Universal Plus IVORY RUBBER DAM Ivory Rubber Dam Starter Kit Ivory Rubber Dam Complete Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2019-03-27
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2019-07-03
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	1996-05-13
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2017-05-31
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	1996-05-13
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2009-08-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-01-06
EIE	Dam, Rubber	Dental	Class 1	872.6300	1994-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kulzer, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011203516	Kulzer SRL	Sacalaz-Judet Timis, RO
3006610834	KULZER GMBH	WASSERBURG Bavaria, DE
9610902	KULZER GMBH	WEHRHEIM Hesse, DE
3005665377	KULZER GMBH	HANAU Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K254063	Kulzer, LLC	iCEM Universal Plus	2025-12-19
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31

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
3001122163	KENT MANUFACTURING COMPANY	Grand Rapids, MI, US
3009426332	GARRECO, LLC	Heber Springs, AR, US
3004623350	ASHTEL STUDIOS, INC.	Ontario, CA, US
3022519816	SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1821514. Last updated year: 2026. Please use registration number 1821514 when referencing this establishment in official correspondence.