Ultradent Products Inc.

Matched from indexed company URL: ULTRADENT PRODUCTS INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1718912	1718912	Ultradent Products Inc.	1	Y	2026-01-01	505 W Ultradent Dr (10200 South) South Jordan UT US 84095
3004977131	3004977131	Ultradent Products Inc. / OraTech LLC	1	N	2020-04-25	10075 South Jordan Gateway South Jordan UT US 84095

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00883205040398	Halo Sectional Matrix System - Halo Short Ring 2pk	801-572-4201	customerservice@ultradent.com
00883205040404	Halo Sectional Matrix System - Halo Extra-Small Wedge 100pk	801-572-4200	customerservice@ultradent.com
00883205040978	Halo Sectional Matrix System - Halo Short Ring 1pk	801-572-4203	customerservice@ultradent.com
00883205044617	Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands with Instruments Kit	801-572-4206	customerservice@ultradent.com
00883205044624	Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands Kit	801-572-4205	customerservice@ultradent.com
00883205044631	Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands Mini Kit	801-572-4204	customerservice@ultradent.com
00883205044648	Halo Sectional Matrix System - Halo Sectional Matrix System Firm Nonstick Bands Kit	801-572-4204	customerservice@ultradent.com
00883205044655	Halo Sectional Matrix System - Halo Sectional Matrix System Firm Stainless Steel Bands Kit	801-572-4202	customerservice@ultradent.com

ultradent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3611	1372736525	K994261	ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT	EMA	2000-02-02
3611	1688310047	K993846	ULTRASEAL XT PLUS	EBC	2000-02-16
147747	1688310047	K993846	ULTRASEAL XT PLUS	EBC	2000-02-16
3611	1151016591	K981596	ULTRAPAK E	MVL	1998-07-31
147747	1151016591	K981596	ULTRAPAK E	MVL	1998-07-31
3611	1002824623	K974413	PERMAFLO	EBF	1998-02-02
3611	2028271766	K974282	VITALESCENCE	EBF	1998-01-29
3611	1390310551	K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	ELW	1997-08-01
3611	1391383031	K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)	ELW	1997-07-16
3611	1736472244	K971284	OPALDAM	EIG	1997-06-03
3611	1905435834	K970114	ULTRACAL XS	EJK	1997-03-14
147747	1905435834	K970114	ULTRACAL XS	EJK	1997-03-14
3611	1590318145	K970113	ULTRA-BLEND PLUS	EJK	1997-04-02
3611	1356776641	K964808	SPETEMP	EMA	1997-02-26
147747	1356776641	K964808	SPETEMP	EMA	1997-02-26
3611	1955957280	K963979	ULTRADENT UNIVERSAL DENTIN SEALANT	LBH	1996-12-12
3611	1086874305	K960696	PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM	KLE	1996-07-18
3611	1265272595	K953526	SEEK	LFC	1995-09-05
147747	1265272595	K953526	SEEK	LFC	1995-09-05
3611	1143211493	K951867	PERMAQUIK BONDING PRIMER	KLE	1995-05-23
3611	1546305225	K951583	PERMAQUIK BONDING PRIMER	KLE	1995-05-12
3611	1433545322	K951582	ULTRADENT PORCELAIN ETCH	EIH	1995-05-10
3611	1592272638	K950859	PERMASEAL	EBF	1995-03-23
3611	1922016212	K941065	DEOX, OXYGEN BARRIER VISCOUS SOLUTION	EMA	1994-06-16
3611	1974509465	K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	ELW	1994-05-27
147747	1974509465	K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	ELW	1994-05-27
3611	1170653812	K934415	FILE-EZE	KJJ	1994-04-13
3611	1909329030	K931868	PRIMADRY PRODUCT LINE	EBC	1993-07-22
147747	1909329030	K931868	PRIMADRY PRODUCT LINE	EBC	1993-07-22
3611	1871468974	K931867	ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE	EBF	1993-09-09
147747	1871468974	K931867	ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE	EBF	1993-09-09
3611	1535103274	K925375	CONSEPSIS SCRUB	LBH	1993-07-22
3611	1382371226	K924982	CONSEPSIS(TM)	LBH	1993-07-08
3611	1527028567	K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	JES	1992-06-16
147747	1527028567	K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	JES	1992-06-16
3611	1213669397	K921409	ENAMEL AND PORCELAIN ETCH PRODUCT LINE	EBF	1992-09-09
3611	1595345233	K921407	COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE	EBF	1992-09-09
3611	1510735355	K913537	MEMOSIL C.D.	ELW	1991-10-04
3611	1573228964	K240694	FORMA Composite (Shade A3D)	EBF	2024-03-15
3611	1677263859	K232498	UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio	EBC	2023-08-18
3611	1966832925	K221909	J-Temp	EBF	2022-07-01
3611	1108205919	K220471	VALO X, VALO X Accessory Lenses	EBZ	2022-02-22
3611	1515557002	K211905	UltraCal XS	KIF	2021-10-13
3611	1412829120	K211531	Cordless Prophy System, Model: i-Polish	EKX	2021-12-17
3611	1070595141	K211237	UltraTemp Rez II	EMA	2021-07-13
3611	1012715792	K210550	VALO Grand Corded and Accessory Lenses	EBZ	2021-03-01
3611	1876810229	K201795	Transcend	EBF	2020-09-28
3611	1196108860	K190627	VALO Grand Corded	EBZ	2019-04-29
3611	2070859948	K181917	MTA2.3 MATERIALS	KIF	2019-01-11
3611	2006780078	K173163	ChlorCid, ChlorCid V, ChlorCid Surf	KJJ	2018-02-09
3611	1630395349	K161239	MTA2.2 MATERIAL	KIF	2016-09-01
3611	1726234498	K160551	VALO Grand	EBZ	2016-07-13
3611	2063400506	K151123	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film	PEM	2016-03-03
3611	1649749131	K151094	Mosaic Universal Composite	EBF	2015-07-21
3611	1346968958	K132953	TIDISHEILD	PEM	2014-02-18
3611	1875402550	K132255	ULTRACEM	EMA	2013-10-24
3611	1935686762	K132109	ENAMELAST	LBH	2013-11-01
147747	1935686762	K132109	ENAMELAST	LBH	2013-11-01
3611	1817110848	K131357	PEAK Z	KLE	2013-09-06
147747	1343251759	K123731	BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY	LFD	2013-01-04
3611	1717833249	K123215	VISCOSTAT CLEAR	MVL	2013-02-05
147747	1717833249	K123215	VISCOSTAT CLEAR	MVL	2013-02-05
3611	1689043250	K122892	MTA2 ROOT AND PULP MATERIALS	KIF	2012-12-11
3611	1307161988	K122039	KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B	EBG	2012-12-27
3611	1958618560	K112517	ULTRASEAL XT HYDRO	EBC	2011-09-23
3611	1148529435	K111836	PERMASHADE VENEER CEMENT	EMA	2011-09-16
3611	1784457011	K111696	OPAL BAND CEMENT	DYH	2011-09-07
3611	1989298815	K111017	CLEARTEMP	EMA	2011-06-06
3611	1405225928	K110582	VALO CORDLESS	EBZ	2011-04-28
147747	1858258201	K103745	BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF	LFD	2011-07-20
3611	2065767019	K102739	HYDROCOLOR 5	ELW	2010-12-08
3611	1397947637	K100752	PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)	KLE	2010-07-16
3611	1956649787	K100301	OPAL BOND FLOW	DYH	2010-04-29
3611	1384862609	K094006	OPAL BOND MV	DYH	2010-03-23
147747	1384862609	K094006	OPAL BOND MV	DYH	2010-03-23
3611	1199715326	K090355	OPAL SEAL	DYH	2009-04-29
3611	1996822016	K083701	PANASIL INITIAL CONTACT AND PANASIL TRAY	ELW	2009-01-09
3611	1719148790	K083647	VALO, MODEL 5919	EBZ	2009-01-23
147747	1719148790	K083647	VALO, MODEL 5919	EBZ	2009-01-23
3611	1661031933	K082560	PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT	ELW	2008-09-08
3611	1922147291	K082157	KETTOSIL AND SILGINAT	ELW	2008-08-06
3611	1028206788	K081120	FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS	ELW	2008-05-01
3611	1013556156	K080768	ULTRATEMP FIRM, FAST AND REGULAR SET	EMA	2008-04-11
3611	2057216040	K071106	ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399	KIF	2007-05-08
3611	1722889451	K071055	OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802	DYW	2007-05-03
3611	1859233402	K070155	INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC	EFB	2007-01-25
3611	1848017168	K063703	CITRIC ACID 20% SOLUTION, MODEL 329	KJJ	2006-12-21
3611	1466664619	K063558	PEAK SE, MODEL 5135	KLE	2006-12-14
3611	1765668239	K061438	ULTRAEZ DESENSITIZING GEL	LBH	2007-06-12
147747	1074148499	K061331	ORAL BALANCE LIQUID/ GEL	LFD	2006-07-25
3611	1015322198	K060335	FILE-EZE	KJJ	2006-02-24
147747	1015322198	K060335	FILE-EZE	KJJ	2006-02-24
3611	1684372368	K052741	IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES	EBW	2006-01-13
3611	1349102232	K050895	SURPASSON P5 NEWTRON	ELC	2005-04-20
3611	1256512905	K043119	AMELOGEN PLUS	EBF	2004-12-17
3611	1019560005	K043118	HYDROGUM SOFT	ELW	2005-01-24
3611	1672541578	K024034	OCCLUFAST ROCK	ELW	2002-12-18
3611	1576116143	K023042	PQ1	KLE	2002-10-28
147747	1040690046
3611	1344363270
3611	1373258456
3611	1572084215
147747	1640909979
147747	1702345850
147747	1795979637
3611	1802953686
3611	1805950711
3611	1932717312
3611	1980590822
3611	2029513550
3611	1040690046
3611	1058649538
3611	1204964282
3611	1211687234
3611	1216199450
3611	1307576799
3611	1363037743
3611	1404676130
3611	1585923125
3611	1612472136

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBF	12	2024-03-15
ELW	12	2010-12-08
EMA	9	2021-07-13
EBZ	7	2022-02-22
KLE	7	2013-09-06
EBC	6	2023-08-18
LBH	6	2013-11-01
KIF	5	2021-10-13
KJJ	5	2018-02-09
DYH	5	2011-09-07
MVL	4	2013-02-05
LFD	3	2013-01-04
EJK	3	1997-04-02
PEM	2	2016-03-03
LFC	2	1995-09-05
JES	2	1992-06-16
EKX	1	2021-12-17
EBG	1	2012-12-27
DYW	1	2007-05-03
EFB	1	2007-01-25
EBW	1	2006-01-13
ELC	1	2005-04-20
EIG	1	1997-06-03
EIH	1	1995-05-10

NDC#

Opalescence Whitening
Ultradent Products, Inc
Sodium Fluoride
Opalescence Sensitivity Relief Whitening
Ultradent Products, Inc.
Potassium Nitrate and Sodium Fluoride
Opal by Opalescence Sensitivity
Ultradent Products, Inc.
Potassium Nitrate and Sodium Fluoride
Opal by Opalescence Original
Ultradent Products, Inc.
Sodium Fluoride
Opal by Opalescence Complete
Ultradent Products, Inc.
Opal by Opalescence Complete
Opalescence Whitening
Ultradent Products, Inc.
Sodium Fluoride
Opalescence Whitening Sensitivity Relief
Ultradent Products, Inc.
Potassium Nitrate and Sodium Fluoride

PMN#

Peak Universal Bond
2024-03-20
Ultradent Products, Inc.
FORMA Composite (Shade A3D)
2024-03-15
Ultradent Products, Inc.
J-Temp
2022-07-01
Ultradent Products, Inc.
VALO X, VALO X Accessory Lenses
2022-02-22
Ultradent Products, Inc.
UltraCal XS
2021-10-13
Ultradent Products, Inc.
UltraTemp Rez II
2021-07-13
Ultradent Products, Inc.
VALO Grand Corded And Accessory Lenses
2021-03-01
Ultradent Products, Inc
VALO Grand Corded
2019-04-29
Ultradent Products, Inc.
ChlorCid, ChlorCid V, ChlorCid Surf
2018-02-09
Ultradent Products, Inc.
VALO Grand
2016-07-13
ULTRADENT PRODUCTS, INC.
Astringedent Clear
2015-09-24
ULTRADENT PRODUCTS, INC.
Mosaic Universal Composite
2015-07-21
ULTRADENT PRODUCTS, INC.
ENAMELAST
2013-11-01
ULTRADENT PRODUCTS INC. / ORATECH LLC
ULTRACEM
2013-10-24
ULTRADENT PRODUCTS INC. / ORATECH LLC
PEAK Z
2013-09-06
ULTRADENT PRODUCTS, INC.
VISCOSTAT CLEAR
2013-02-05
ULTRADENT PRODUCTS, INC.
ULTRASEAL XT HYDRO
2011-09-23
ULTRADENT PRODUCTS, INC.
PERMASHADE VENEER CEMENT
2011-09-16
ULTRADENT PRODUCTS, INC.
OPAL BAND CEMENT
2011-09-07
ULTRADENT PRODUCTS, INC.
CLEARTEMP
2011-06-06
ULTRADENT PRODUCTS, INC.
VALO CORDLESS
2011-04-28
ULTRADENT PRODUCTS, INC.
ULTRASEAL ID
2010-09-17
ULTRADENT PRODUCTS, INC.
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
2010-07-16
ULTRADENT PRODUCTS, INC.
OPAL BOND FLOW
2010-04-29
ULTRADENT PRODUCTS, INC.
OPAL BOND MV
2010-03-23
ULTRADENT PRODUCTS, INC.
OPAL SEAL
2009-04-29
ULTRADENT PRODUCTS, INC.
VALO, MODEL 5919
2009-01-23
ULTRADENT PRODUCTS, INC.
ULTRATEMP FIRM, FAST AND REGULAR SET
2008-04-11
ULTRADENT PRODUCTS, INC.
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
2008-02-08
ULTRADENT PRODUCTS, INC.
ULTRAEZ DESENSITIZING GEL
2007-06-12
ULTRADENT PRODUCTS, INC.
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
2007-05-08
ULTRADENT PRODUCTS, INC.
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
2007-05-03
ULTRADENT PRODUCTS, INC.
CITRIC ACID 20% SOLUTION, MODEL 329
2006-12-21
ULTRADENT PRODUCTS, INC.
PEAK SE, MODEL 5135
2006-12-14
ULTRADENT PRODUCTS, INC.
PEAK BOND, MODEL 5133
2006-12-12
ULTRADENT PRODUCTS, INC.
FILE-EZE
2006-02-24
ULTRADENT PRODUCTS, INC.
GI DENTSTAT
2006-02-23
ULTRADENT PRODUCTS, INC.
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
2005-09-19
ULTRADENT PRODUCTS, INC.
CALC-I-OSS
2005-07-19
ULTRADENT PRODUCTS, INC.
AMELOGEN PLUS
2004-12-17
ULTRADENT PRODUCTS, INC.

101 records. Showing 1-40. Next

GUDID#

Halo Sectional Matrix System - Halo Sectional Matrix System Firm Stainless Steel Bands Kit
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Sectional Matrix System Firm Nonstick Bands Kit
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands Mini Kit
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands Kit
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Sectional Matrix System Original Bands with Instruments Kit
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Short Ring 1pk
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Short Ring 2pk
ULTRADENT PRODUCTS, INC.
2026-06-26
Halo Sectional Matrix System - Halo Extra-Small Wedge 100pk
ULTRADENT PRODUCTS, INC.
2026-06-25
ViscoStat Clear - ViscoStat Clear IndiSpense Refill
ULTRADENT PRODUCTS, INC.
2018-04-28
ViscoStat Clear - ViscoStat Clear Dento-Infusor Indispense Kit
ULTRADENT PRODUCTS, INC.
2018-04-28
ViscoStat Clear - ViscoStat Clear Dento-Infusor Kit
ULTRADENT PRODUCTS, INC.
2018-04-28
ViscoStat Clear - ViscoStat Clear Econo Refill
ULTRADENT PRODUCTS, INC.
2018-04-28
ViscoStat Clear - VISCOSTAT CLEAR SAMPLE
ULTRADENT PRODUCTS, INC.
2018-04-28
Peak Universal Bond - Peak Universal Bond Sample
ULTRADENT PRODUCTS, INC.
2026-04-28
Peak Universal Bond - Peak Universal Bond Sample SE
ULTRADENT PRODUCTS, INC.
2026-04-28
UltraSeal - Sample U-Seal XT Hydro
ULTRADENT PRODUCTS, INC.
2026-04-28
Universal Dentin Sealant - Universal Dentin Sealant Refill Universal
ULTRADENT PRODUCTS, INC.
2026-04-28
ClearTemp LC - Sample ClearTemp LC Temporary Veneer Cement
ULTRADENT PRODUCTS, INC.
2026-04-28
ClearTemp LC - ClearTemp LC Temporary Veneer Cement Refill
ULTRADENT PRODUCTS, INC.
2026-04-28
Porcelain Etch - Porcelain Etch/Silane Mini Kit Universal
ULTRADENT PRODUCTS, INC.
2026-03-28
Peak Universal Bond - Peak Universal Bond Total-Etch Intro Kit
ULTRADENT PRODUCTS, INC.
2026-03-28
Peak Universal Bond - Peak Universal Bond 4ml bottle, Total Etch kit
ULTRADENT PRODUCTS, INC.
2026-03-28
Peak Universal Bond - Peak Universal Bond 4ml Bottle, Self-Etch Kit
ULTRADENT PRODUCTS, INC.
2026-03-28
UltraSeal XT - U-Seal XT Hydro Kit Natural
ULTRADENT PRODUCTS, INC.
2026-03-28
UltraSeal XT - U-Seal XT Hydro Kit OP White
ULTRADENT PRODUCTS, INC.
2026-03-28
Porcelain Etch - Porcelain Etch Kit
ULTRADENT PRODUCTS, INC.
2026-03-28
Porcelain Repair - Porcelain Repair Kit
ULTRADENT PRODUCTS, INC.
2026-03-28
Opalustre - Opalustre Kit
ULTRADENT PRODUCTS, INC.
2026-03-10
PermaShade LC - Sample PermaShade LC Veneer Cement Translucent
ULTRADENT PRODUCTS, INC.
2026-02-12
PermaShade LC - PermaShade LC Light Cure Veneer Cement Refill - B1
ULTRADENT PRODUCTS, INC.
2026-02-12
PermaShade LC - PermaShade LC Light Cure Veneer Cement Refill - A2
ULTRADENT PRODUCTS, INC.
2026-02-12
PermaShade LC - PermaShade LC Light Cure Veneer Cement Refill - Opaque White
ULTRADENT PRODUCTS, INC.
2026-02-12
PermaShade LC - PermaShade LC Veneer Cement Refill -Translucent
ULTRADENT PRODUCTS, INC.
2026-02-12
Enamelast - Enamelast Caramel Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Bubble Gum Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Orange Cream Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Walterberry Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Cool Mint Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Flavor Free Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11
Enamelast - Enamelast Raspberry Single Cup 200pk
ULTRADENT PRODUCTS, INC.
2026-02-11

200 records. Showing 1-40. Next