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ULTRADENT PRODUCTS, INC.

United States·US-MF-000013697

Last updated May 24, 2026

What ULTRADENT PRODUCTS, INC. makes

The company manufactures dental composite resins, including tooth-colored filling materials and endodontic sealants, as well as orthodontic ceramic brackets for braces. It also produces polymerization lamps for curing dental materials, silicone impression materials for molds, and reusable abrasive disks for polishing teeth. Additional products include dental etching solutions, desensitizing coatings for teeth, and unfilled resin sealants for protective coatings.

The portfolio includes devices classified as Class I, Class II, Class IIa, and unclassified (U) under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 505 West Ultradent Drive, South Jordan, United States
Website: www.ultradent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(801)572-4200
PRRC Contact: —
EUDAMED SRN: US-MF-000013697
FDA FEI Number: —
DUNS Number: 013369913

Catalogue (1409)

Page 1 of 29

Device	Model / Reference	Registries	Class	Status
Opalescence Boost	4754-CE	EUDAMED	Class IIa	Active
Opalescence Boost	4750-FR	EUDAMED	Class IIa	Active
Opalescence Boost	4751-FR	EUDAMED	Class IIa	Active
Opalescence Quick 45% PF	5346	EUDAMED	Class IIa	Active
Opalescence Quick 45% PF	5348	EUDAMED	Class IIa	Active
Opalescence Endo	1323	EUDAMED	Class IIa	Active
Endo-Eze MTAFlow White	5980	EUDAMED	Class IIa	Active
Halo Sectional Matrix System	5882	EUDAMED	Class I	Active
Opalescence Endo	1270	EUDAMED	Class IIa	Active
Opalescence Boost	4754-FR	EUDAMED	Class IIa	Active
Opalescence Boost	4750-CE	EUDAMED	Class IIa	Active
ultrapro Tx air	8505-	FDA UDI	Class I	Active
PermaFlo	963	EUDAMEDFDA UDI	Class II	Active
Mosaic	4791	FDA UDI	Class II	Active
Luna	221111	FDA UDI	Class II	Active
Chromaclone	5011	FDA UDI	Class II	Active
Vit-l-escence	442	FDA UDI	Class II	Active
Avex CX	214006	FDA UDI	Class I	Active
Vit-l-escence	418	FDA UDI	Class II	Active
Opal-Etch	500092	FDA UDI	Class I	Active
Jiffy Polisher	890	FDA UDI	Class I	Active
Avex CX	224033	FDA UDI	Class I	Active
Vit-l-escence	1198	FDA UDI	Class II	Active
Ultradent Cheek Retractor	4871	FDA UDI	Class I	Active
Opal Blue	500019-	FDA UDI	Class I	Active
ViscoStat Clear	S646	FDA UDI	U	Active
Vit-l-escence	356	FDA UDI	Class II	Active
Jiffy Polisher	848	FDA UDI	Class I	Active
Valo	4319-	EUDAMEDFDA UDI	Class II	Active
Amelogen Plus	3254	FDA UDI	Class II	Unknown
Valo	13835	FDA UDI	Class II	Active
Jiffy	4251	FDA UDI	Class I	Active
Consepsis	689	FDA UDI	Class II	Active
Avex CX	225004	FDA UDI	Class I	Active
UniCore	7125	EUDAMEDFDA UDI	Class I	Active
Avex CX	224027	FDA UDI	Class I	Active
Enamelast	4366	FDA UDI	Class II	Unknown
Forma S	6028	FDA UDI	Class II	Active
Opal-Etch	500093	FDA UDI	Class I	Active
Vit-l-escence	421	FDA UDI	Class II	Active
EndoREZ Points	1839	FDA UDI	Class I	Active
Valo	4667-	FDA UDI	Class II	Active
Luna	211311	FDA UDI	Class II	Active
Silane	410	EUDAMEDFDA UDI	Class II	Active
Amelogen Plus	9039	FDA UDI	Class II	Active
Vit-l-escence	1188	FDA UDI	Class II	Active
Thermo Clone VPS	4072-	FDA UDI	Class II	Active
Valo	4629-	EUDAMEDFDA UDI	Class II	Active
Enamelast	4521	FDA UDI	Class II	Active
Avex CX	214009	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Ultradent Products GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Ultradent Products, Inc. has 20 recall records spanning from May 24, 2012, to January 28, 2026, with statuses including completed, open, classified, and terminated. The recalls involve issues such as missing resin in a primer, mislabeling of products (including incorrect part numbers and barcodes), incomplete manufacturing processes (e.g., floss tether holes not punched through, incomplete design control), packaging errors (e.g., mislabeled brackets, cartridges, and barcodes), potential cross-contamination in composite materials, and defects like loose cannulas, crumbling polisher cups, and off-flavored varnish. Reasons cited include field complaints, labeling discrepancies, and voluntary field actions initiated by the manufacturer.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 28, 2026	Z-1689-2026	—	open, classified	Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Aug 2, 2024	Z-3068-2024	—	open, classified	Due to a manufacturing issue, red particulates present in the expressed composite.
Aug 2, 2024	Z-3067-2024	—	open, classified	Due to a manufacturing issue, red particulates present in the expressed composite.
Aug 2, 2024	Z-3066-2024	—	open, classified	Due to a manufacturing issue, red particulates present in the expressed composite.
Jun 1, 2022	Z-1368-2022	—	completed	SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Aug 31, 2020	Z-0053-2021	—	terminated	Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Jul 12, 2018	Z-0690-2019	—	terminated	Dental varnish has the possibility of having an unpleasant and off flavor.
Aug 4, 2017	Z-3217-2017	—	terminated	The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Aug 4, 2017	Z-3215-2017	—	terminated	The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Aug 4, 2017	Z-3214-2017	—	terminated	The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Aug 4, 2017	Z-3218-2017	—	terminated	The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Aug 4, 2017	Z-3216-2017	—	terminated	The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Dec 14, 2016	Z-1034-2017	—	terminated	Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
Nov 17, 2016	Z-0704-2017	—	terminated	There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
Dec 22, 2015	Z-0583-2016	—	terminated	Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
Nov 19, 2013	Z-0481-2014	—	terminated	Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Feb 8, 2013	Z-0876-2013	—	terminated	Orthodontic brackets distributed was incorrectly labeled.
Feb 4, 2013	Z-0811-2013	—	terminated	Incorrect packaging of regular set and fast set cartridges.
Feb 4, 2013	Z-0812-2013	—	terminated	Incorrect packaging of regular set and fast set cartridges.
May 24, 2012	Z-1822-2012	—	terminated	Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.