Data / Medical devices / Germany / Deltamed GMBH

Deltamed GMBH: FDA-registered device maker in FRIEDBERG Hesse, Germany, 21 510(k) clearances

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

Deltamed GMBH is registered with the FDA (registration 3002789526) in FRIEDBERG Hesse, Germany. It lists 14 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3002789526
Address: RAIFFEISENSTR. 8a, FRIEDBERG Hesse, Germany, D-61169
Owner or operator: DELTAMED GMBH (9026386)
Roles: Manufacturer
First device listed: February 8, 2006
Registered through: 2027
Brand names listed: 3Delta Crown, 3Delta Denture Base, 3Delta Denture Bond, 3Delta Denture Fix, 3Delta Denture Teeth, 3Delta Etemp, 3Delta Guide XT, 3Delta Tray and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Plate, Base, Shellac	EEA	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	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 18, 2024	K243720	3Delta UNlimited	EBF	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
July 24, 2024	K240714	Insure® Universal; Insure® Universal Automix	EMA	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
April 6, 2023	K230341	ACRIFIX	EBI	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
October 11, 2022	K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
January 10, 2022	K212541	3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix	EBI	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
December 6, 2021	K211804	3Delta Crown	EBF	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
June 24, 2021	K211259	Renamel Bulkfill	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
July 31, 2020	K200039	P pro Crown & Bridge	EBG	Substantially Equivalent	Deltamed GmbH	accessdata.fda.gov
December 5, 2017	K172707	Renamel Microfill	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
February 24, 2017	K163480	Renamel NANO +plus	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
November 20, 2009	K092730	COSMEDENT BRUSHABLE COMPOSITE	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
October 21, 2005	K052501	MULTIPLE RESIN TOOTH BONDING AGENT	KLE	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
December 1, 2004	K042823	COSMEDENT PIT & FISSURE SEALANT	EBC	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
June 3, 2004	K040994	COSMEDENT CORE PASTE	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
September 17, 2003	K030832	PRIMOSPLINT SYSTEM	MQC	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
February 10, 1998	K974494	RENAMEL FLOWABLE COMPOSITE	EBD	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
June 16, 1992	K921820	RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
January 10, 1990	K894477	INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM	EMA	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
December 29, 1987	K873356	INSURE PORCELAIN VENEER BONDING SYSTEM	EMA	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
August 12, 1986	K862912	RENAMELIZE POLISHING PASTE	EJR	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
March 13, 1986	K854755	RENAMEL ESTHETIC RESTORATIVE SYSTEM	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2024. 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.