Chrysalis Intelligence · Sponsors · Ultradent Products, Inc.

Ultradent Products, Inc.

South Jordan, UT, US · 9 510(k) clearances · 6 recalls

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Total clearances
9
2021-03-01 → 2026-07-01
Last 12 months
2
Product codes
6
Most recent
2026-07-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EBF Material, Tooth Shade, Resin Class II Dental 3 2026-07-01
EBZ Activator, Ultraviolet, For Polymerization Class II Dental 2 2022-02-22
LBH Varnish, Cavity Class II Dental 1 2026-04-30
KLE Agent, Tooth Bonding, Resin Class II Dental 1 2024-03-20
KIF — — — 1 2021-10-13
EMA Cement, Dental Class II Dental 1 2021-07-13
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
4
Most recent
2026-01-28
DateSeverityStatusRecall # ProductCodeReason
2026-01-28 Class II Ongoing Z-1689-2026 Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. — Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
2024-08-02 Class II Ongoing Z-3068-2024 Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Sof… — Due to a manufacturing issue, red particulates present in the expressed composite.
2024-08-02 Class II Ongoing Z-3067-2024 Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: … — Due to a manufacturing issue, red particulates present in the expressed composite.
2024-08-02 Class II Ongoing Z-3066-2024 Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A P… — Due to a manufacturing issue, red particulates present in the expressed composite.
2022-06-01 Class II Completed Z-1368-2022 Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime… — 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…
2020-08-31 Class II Terminated Z-0053-2021 PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow… — Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-07-01 K262228 Transcend Bulk Fill Flowable Composite EBF Class II Dental
2026-04-30 K261404 UltraEZ LBH Class II Dental
2024-03-20 K240743 Peak Universal Bond KLE Class II Dental
2024-03-15 K240694 FORMA Composite (Shade A3D) EBF Class II Dental
2022-07-01 K221909 J-Temp EBF Class II Dental
2022-02-22 K220471 VALO X, VALO X Accessory Lenses EBZ Class II Dental
2021-10-13 K211905 UltraCal XS KIF — —
2021-07-13 K211237 UltraTemp Rez II EMA Class II Dental
2021-03-01 K210550 VALO Grand Corded and Accessory Lenses EBZ Class II Dental
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence