510(k) Report

FDA applicant

Ultradent Products, Inc.

South Jordan, UT104 decisions1992–20265 recalls

FDA records 104 decisions for Ultradent Products, Inc. (South Jordan, UT) from 1992 to 2026: 104 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 3 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 48 predicates, 24 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Ultradent Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007: 32008: 22009: 22010: 42011: 52013: 22015: 22016: 12018: 12019: 12021: 32022: 22024: 22026 (partial year): 2
2007high 5 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2024

2012: 12016: 12020: 12022: 12024: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ultradent Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ultradent Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KLEAgent, Tooth Bonding, Resin19decisions
  • EBFMaterial, Tooth Shade, Resin17decisions
  • EMACement, Dental9decisions
  • LBHVarnish, Cavity9decisions
  • EBCSealant, Pit And Fissure, And Conditioner7decisions
  • EBZActivator, Ultraviolet, For Polymerization7decisions

Also: KJJ (5), KIF (5), EJK (5), MVL (4), DYH (4), DYW (3).

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 3 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 9 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 48 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 71 times; 24 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110582Valo CordlessUltradent Products, Inc. · 20116cite it
  • K061438Ultraez Desensitizing GelUltradent Products, Inc. · 20074cite it
  • K925375Consepsis ScrubUltradent Products, Inc. · 19934cite it
  • K123215Viscostat ClearUltradent Products, Inc. · 20133cite it
  • K993846Ultraseal XT PlusUltradent Products, Inc. · 20003cite it
  • K100752Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 20103cite it

What has FDA decided for it lately?

  • K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026
  • K261404UltraEZUltradent Products, Inc. · 2026
  • K240743Peak Universal BondUltradent Products, Inc. · 2024
  • K240694FORMA Composite (Shade A3D)Ultradent Products, Inc. · 2024
  • K221909J-TempUltradent Products, Inc. · 2022
  • K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
  • K211905UltraCal XSUltradent Products, Inc. · 2021
  • K211237UltraTemp Rez IIUltradent Products, Inc. · 2021

All 104 as Ultradent Products, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K974282Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number…Aug 2, 2024Class II
  • K063558Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch…Jun 1, 2022Class II
  • K974413PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured…Aug 31, 2020Class II
  • K993846UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus.…Nov 17, 2016Class II
  • K063558Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South…May 24, 2012Class II

Other applicant names beginning “Ultradent”

FDA records each applicant name separately; these may or may not be the same firm.

Ultradent Products Inc. / Oratech, LLC 2Ultradent Product, Inc. 2