Data / Medical devices / Germany / Kulzer GMBH

Kulzer GMBH: FDA-registered device maker in WEHRHEIM Hesse, Germany, 1 510(k) clearance

Name: Kulzer GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kulzer GMBH is registered with the FDA (registration 9610902) in WEHRHEIM Hesse, Germany. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 7, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9610902
FEI number: 3002807166
Address: Philipp-Reis-Strasse 8/13, WEHRHEIM Hesse, Germany, D-61273
Owner or operator: Kulzer, LLC (9056636)
Roles: Contract manufacturer, Manufacturer
First device listed: September 20, 2006
Registered through: 2026
Brand names listed: Charisma, Charisma ABC, FLEXITIME MONOPHASE PRO SCAN, Gluma Comfort Bond + Desensitizer, Gluma Desensitizer, Gluma Etch 35 Gel, IBond Universal and iBond Ceramic Primer, PALA cre-active and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Contract manufacturer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Contract manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Contract manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Contract manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Contract manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Contract manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Contract manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Contract manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Contract manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Contract manufacturer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Contract manufacturer	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
December 7, 2012	K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	KLE	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov

Compare with other makers

Updated December 7, 2012. 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.