COSMEDENT, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1450653	1450653	COSMEDENT, INC.	1	Y	2026-01-01	4646 N. RAVENSWOOD AVE. CHICAGO IL US 60640

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
2639	1159409933	K993659	RENAMEL PACK	EBF	2000-01-18
2639	1773007807	K993658	RENAMEL SCULPT	EBF	2000-01-18
2639	2065650276	K992001	TRAY-LINK	ELW	1999-11-02
2639	1254884360	K980800	LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBF	1998-11-09
2639	1527435380	K980799	HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBG	1998-10-28
2639	1960481056	K980298	FLOWABLE HYBRID	EBD	1998-03-09
2639	1884920424	K974494	RENAMEL FLOWABLE COMPOSITE	EBD	1998-02-10
2639	1043113511	K974014	PULPDENT DENTASTIC UNO	EMA	1997-12-17
2639	1343494759	K973201	PROVI CEMENT	EMA	1998-06-05
2639	1093018492	K960938	PROV-KB	EBG	1996-04-18
2639	1657946989	K930989	PULPDENT UNFILLED DUAL CURE BONDING RESIN	KLE	1993-04-20
2639	1561477599	K926074	PULPDENT DENTAL BOND ENCHANCER	EBF	1993-03-16
2639	1462105335	K924132	E.Z. TEMEP, TEMPORARY FILLING MATERIAL	EMA	1993-07-08
2639	1527540263	K924132	E.Z. TEMEP, TEMPORARY FILLING MATERIAL	EMA	1993-07-08
2639	1495028242	K921820	RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION	EBF	1992-06-16
2639	1552200012	K910803	ENAMEL ETCHING GEL	DYH	1991-03-15
2639	1836817310	K894477	INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM	EMA	1990-01-10
2639	1480989392	K873356	INSURE PORCELAIN VENEER BONDING SYSTEM	EMA	1987-12-29
2639	1557855544	K862912	RENAMELIZE POLISHING PASTE	EJR	1986-08-12
2639	1662101568	K854755	RENAMEL ESTHETIC RESTORATIVE SYSTEM	EBF	1986-03-13
2639	1946798531	K854588	INSTA-GLAZE	EJR	1986-02-04
2639	1270120946	K854494	CERAM-ETCH	EBC	1985-12-23
2639	1214060379	K240714	Insure® Universal; Insure® Universal Automix	EMA	2024-07-24
2639	1790319909	K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	EBF	2022-10-11
2639	1084363101	K211259	Renamel Bulkfill	EBF	2021-06-24
2639	1612939118	K172707	Renamel Microfill	EBF	2017-12-05
2639	1719948152	K163480	Renamel NANO +plus	EBF	2017-02-24
2639	1050494297	K132393	CERCOM II CEMENT	EMA	2014-03-14
2639	1529005974	K092730	COSMEDENT BRUSHABLE COMPOSITE	EBF	2009-11-20
2639	1113799627	K091735	DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT	EMA	2009-09-25
2639	1297621784	K070583	NANO COMPOSITE	EBF	2007-04-16
2639	1584025534	K060881	TEMPORARY CROWN & BRIDGE RESIN	EBG	2006-05-16
2639	1464269195	K053018	POLY SILOXANE IMPRESSION MATERIAL	ELW	2005-11-08
2639	1627109448	K052501	MULTIPLE RESIN TOOTH BONDING AGENT	KLE	2005-10-21
2639	1716012725	K052263	MULTIPLE (TOOTH DESENSITIZER)	LBH	2005-12-16
2639	1248749226	K042823	COSMEDENT PIT & FISSURE SEALANT	EBC	2004-12-01
2639	1915610434	K041229	MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)	ELW	2004-06-17
2639	1738203851	K040994	COSMEDENT CORE PASTE	EBF	2004-06-03
2639	1173320587	K011239	GINDA GUARD	EBD	2002-02-14
2639	1059440809	K010012	LC PROVIFILL	EBG	2001-02-14
2639	1096563536
2639	1105012851
2639	1171925716
2639	1226418291
2639	1350499084
2639	1545197166
2639	1602837621
2639	1708820595
2639	1711363882
2639	1749807477
2639	1984324474
2639	2023729170
2639	2058980558

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBF	13	2022-10-11
EMA	9	2024-07-24
EBG	4	2006-05-16
ELW	3	2005-11-08
EBD	3	2002-02-14
KLE	2	2005-10-21
EBC	2	2004-12-01
EJR	2	1986-08-12
LBH	1	2005-12-16
DYH	1	1991-03-15

PMN#

Insure® Universal; Insure® Universal Automix
2024-07-24
Cosmedent, Inc.
COSMEDENT BRUSHABLE COMPOSITE
2009-11-20
COSMEDENT, INC.
NANO COMPOSITE
2007-04-16
COSMEDENT, INC.
TEMPORARY CROWN & BRIDGE RESIN
2006-05-16
COSMEDENT, INC.
MULTIPLE (TOOTH DESENSITIZER)
2005-12-16
COSMEDENT, INC.
MULTIPLE RESIN TOOTH BONDING AGENT
2005-10-21
COSMEDENT, INC.
COSMEDENT PIT & FISSURE SEALANT
2004-12-01
COSMEDENT, INC.
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
2004-06-17
COSMEDENT, INC.
COSMEDENT CORE PASTE
2004-06-03
COSMEDENT, INC.
PRIMOSPLINT SYSTEM
2003-09-17
COSMEDENT, INC.
GINDA GUARD
2002-02-14
COSMEDENT, INC.
RENAMEL SCULPT
2000-01-18
COSMEDENT, INC.
RENAMEL PACK
2000-01-18
COSMEDENT, INC.
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
1998-11-09
COSMEDENT, INC.
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
1998-10-28
COSMEDENT, INC.
FLOWABLE HYBRID
1998-03-09
COSMEDENT, INC.
RENAMEL FLOWABLE COMPOSITE
1998-02-10
COSMEDENT, INC.
E.Z. TEMEP, TEMPORARY FILLING MATERIAL
1993-07-08
COSMEDENT, INC.
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
1992-06-16
COSMEDENT, INC.
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
1990-01-10
COSMEDENT, INC.
DENTIN BONDING SYSTEM
1989-10-24
COSMEDENT, INC.
INSURE PORCELAIN VENEER BONDING SYSTEM
1987-12-29
COSMEDENT, INC.
RENAMELIZE POLISHING PASTE
1986-08-12
COSMEDENT, INC.
RENAMEL ESTHETIC RESTORATIVE SYSTEM
1986-03-13
COSMEDENT, INC.

GUDID#

PorcelEtch - 661101
COSMEDENT, INC.
2016-09-22
PorcelEtch - 663101
COSMEDENT, INC.
2016-09-22
PorcelEtch - 663102
COSMEDENT, INC.
2016-09-22
CompositeEtch - 663103
COSMEDENT, INC.
2016-09-22
PorcelEtch - 663104
COSMEDENT, INC.
2016-09-22
Prevue Refill Kit - Prevue Try-In Refill Kit includes 5 (2.5g) syringes of Prevue Try-In Gel, 2 Cosmedent brushes (#1 and #3),and Syringe Tips (20 pack-19 gauge).
COSMEDENT, INC.
2016-09-22
Enamelize - 906000
COSMEDENT, INC.
2016-09-22
Enamelize - 906101
COSMEDENT, INC.
2016-09-22
Porcelize - 906104
COSMEDENT, INC.
2016-09-22
Porcelize - 906105
COSMEDENT, INC.
2016-09-22
Porcelize Kit - 906102
COSMEDENT, INC.
2020-01-21
Complete Dual-Cure Catalyst - 654103
COSMEDENT, INC.
2016-09-22
Complete Unfilled Resin - 654104
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6061A2
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6062A2
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6062B2
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6062MI
COSMEDENT, INC.
2016-09-22
IPC Off-Angle Long - 100ROD
COSMEDENT, INC.
2023-09-12
ResinKeeper - 901101
COSMEDENT, INC.
2020-02-17
Renamel® Flowable Microhybrid - 70110W
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011A1
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011A2
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011A3
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011A4
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011B1
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011B2
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011B3
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011C2
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011C3
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011C4
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011CO
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011D3
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 7011MI
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 701A35
COSMEDENT, INC.
2016-09-22
Renamel® Flowable Microhybrid - 701MWO
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 60610W
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6061A1
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6061A3
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6061A4
COSMEDENT, INC.
2016-09-22
Renamel® Microhybrid - 6061B0
COSMEDENT, INC.
2016-09-22

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