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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 3 of 29

Device	Model / Reference	Registries	Class	Status
Absorbent Paper Points	1555	FDA UDI	Class I	Active
Avex CX	215001	FDA UDI	Class I	Active
Luna	211110	FDA UDI	Class II	Active
Luna	211310	FDA UDI	Class II	Active
Jiffy	4246	FDA UDI	Class I	Active
MTAFlow	3981	EUDAMEDFDA UDI	Class II	Active
Amelogen Plus	8015	FDA UDI	Class II	Active
Ease-In-Shields	5837	FDA UDI	Class I	Active
Luna	221315	FDA UDI	Class II	Active
Mosaic	4778-	FDA UDI	Class II	Active
Jiffy	4238	FDA UDI	Class I	Active
Luna	221310	FDA UDI	Class II	Active
Genius Variable Operating System	4056	FDA UDI	Class I	Active
ChlorCid	4612	FDA UDI	U	Active
Jiffy	4243	FDA UDI	Class I	Active
UltraSeal XT	733	FDA UDI	Class II	Active
PropGard	4105	FDA UDI	Class I	Active
Avex CX	225006	FDA UDI	Class I	Active
Seek	210	FDA UDI	Class II	Active
EndoREZ Points	3358	FDA UDI	Class I	Active
TriAway	1375-	FDA UDI	Class I	Active
Chromaclone	7601	FDA UDI	Class II	Active
Valo	5437	FDA UDI	Class II	Active
Amelogen Plus	8010	FDA UDI	Class II	Active
UniCore	7126	EUDAMEDFDA UDI	Class I	Active
Opal Bond MV	500066	FDA UDI	Class II	Active
Consepsis	732	FDA UDI	Class II	Active
Luna	221103	FDA UDI	Class II	Active
Ultra-Etch	997	FDA UDI	Class II	Active
Valo	13837	FDA UDI	Class II	Active
PermaShade Try-In Paste	5780	FDA UDI	Class II	Active
Avex CX	214026	FDA UDI	Class I	Active
Amelogen Plus	8018	FDA UDI	Class II	Active
Valo X	6497-LN	FDA UDI	Class II	Active
PrimaDry	7663	FDA UDI	Class II	Active
Transcend	4730-	FDA UDI	Class II	Active
PermaFlo	7667	FDA UDI	Class II	Active
MTA Flow White	4980	FDA UDI	Class II	Active
Gingival Barrier	3552	FDA UDI	Class I	Active
Ultra-Blend Plus	416	FDA UDI	Class II	Active
UniCore	4092	FDA UDI	Class I	Active
Luna	211202	FDA UDI	Class II	Active
Chromaclone	5032	FDA UDI	Class II	Active
Luna	211112	FDA UDI	Class II	Active
Amelogen Plus	8019	FDA UDI	Class II	Active
Chromaclone	5020	FDA UDI	Class II	Active
Jiffy	4248	FDA UDI	Class I	Active
Avex CX	224039	FDA UDI	Class I	Active
Amelogen Plus	9037	FDA UDI	Class II	Active
Avex CX	524034	FDA UDI	Class II	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.