Data / Medical devices / United States / Cosmedent, Inc.

Cosmedent, Inc.: FDA-registered device maker in Chicago, IL, United States, 39 510(k) clearances

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

Cosmedent, Inc. is registered with the FDA (registration 1450653) in Chicago, IL, United States. It lists 24 device types. The FDA files 39 510(k) clearances under its listings, the newest dated July 24, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Cosmedent, Inc.

FDA registration number: 1450653
Address: 4646 N. Ravenswood Ave., Chicago, IL, United States, 60640
Owner or operator: COSMEDENT, INC. (1450653)
Roles: Repackager or relabeler
First device listed: March 2, 2006
Registered through: 2026
Brand names listed: All Ceramic Polishers, Brush and Sculpt, BulkFill, Complete Dual-Cure Catalyst, Complete Primer/Unfilled Resin, Complete Unfilled Resin, Composite Pacement Instruments, CompositeEtch and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Repackager or relabeler	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Mercury And/Or Alloy	EHE	1	Repackager or relabeler	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Repackager or relabeler	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Point, Abrasive	EHL	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Repackager or relabeler	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Repackager or relabeler	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
July 24, 2024	K240714	Insure® Universal; Insure® Universal Automix	EMA	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
October 11, 2022	K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
June 24, 2021	K211259	Renamel Bulkfill	EBF	Substantially Equivalent	Cosmedent, Inc.	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
March 14, 2014	K132393	CERCOM II CEMENT	EMA	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
November 20, 2009	K092730	COSMEDENT BRUSHABLE COMPOSITE	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
September 25, 2009	K091735	DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT	EMA	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
April 16, 2007	K070583	NANO COMPOSITE	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
May 16, 2006	K060881	TEMPORARY CROWN & BRIDGE RESIN	EBG	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
December 16, 2005	K052263	MULTIPLE (TOOTH DESENSITIZER)	LBH	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
November 8, 2005	K053018	POLY SILOXANE IMPRESSION MATERIAL	ELW	Substantially Equivalent	Millennium Dental International, 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 17, 2004	K041229	MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)	ELW	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
June 3, 2004	K040994	COSMEDENT CORE PASTE	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
February 14, 2002	K011239	GINDA GUARD	EBD	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
February 14, 2001	K010012	LC PROVIFILL	EBG	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
January 18, 2000	K993659	RENAMEL PACK	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
January 18, 2000	K993658	RENAMEL SCULPT	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
November 2, 1999	K992001	TRAY-LINK	ELW	Substantially Equivalent	Silicon-Und Composite Spezialitaten GmbH	accessdata.fda.gov
November 9, 1998	K980800	LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
October 28, 1998	K980799	HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBG	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
June 5, 1998	K973201	PROVI CEMENT	EMA	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
March 9, 1998	K980298	FLOWABLE HYBRID	EBD	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
February 10, 1998	K974494	RENAMEL FLOWABLE COMPOSITE	EBD	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
December 17, 1997	K974014	PULPDENT DENTASTIC UNO	EMA	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
April 18, 1996	K960938	PROV-KB	EBG	Substantially Equivalent	Silicon-Und Composite Spezialitaten GmbH	accessdata.fda.gov
July 8, 1993	K924132	E.Z. TEMEP, TEMPORARY FILLING MATERIAL	EMA	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
April 20, 1993	K930989	PULPDENT UNFILLED DUAL CURE BONDING RESIN	KLE	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
March 16, 1993	K926074	PULPDENT DENTAL BOND ENCHANCER	EBF	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
June 16, 1992	K921820	RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION	EBF	Substantially Equivalent	Cosmedent, Inc.	accessdata.fda.gov
March 15, 1991	K910803	ENAMEL ETCHING GEL	DYH	Substantially Equivalent	Gresco Products, 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
February 4, 1986	K854588	INSTA-GLAZE	EJR	Substantially Equivalent	George Taub Products & Fusion Co., Inc.	accessdata.fda.gov
December 23, 1985	K854494	CERAM-ETCH	EBC	Substantially Equivalent	Gresco Products, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 20, 2023	92812	Class II	Ongoing	Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #, Rx.	Reports were received the elastomer cup material is crumbling.	accessdata.fda.gov
September 28, 2017	78479	Class II	Terminated	Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.	Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.	accessdata.fda.gov

Compare with other makers

Updated July 24, 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.