Ultradent Products, Inc.
Ultradent Products, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2026, with 20 FDA device recalls on record.
Top product codes for Ultradent Products, Inc.
FDA recalls by Ultradent Products, Inc.
10 most recent of 20- Z-1689-2026 — Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
- Z-3067-2024 — Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
- Z-3068-2024 — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
- Z-3066-2024 — Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A
- Z-1368-2022 — Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
- Z-0053-2021 — PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
- Z-0690-2019 — Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
- Z-3215-2017 — Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
- Z-3218-2017 — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
- Z-3216-2017 — Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ultradent Products, Inc.
1–100 of 104- K262228 — Transcend Bulk Fill Flowable Composite
- K261404 — UltraEZ
- K240743 — Peak Universal Bond
- K240694 — FORMA Composite (Shade A3D)
- K221909 — J-Temp
- K220471 — VALO X, VALO X Accessory Lenses
- K211905 — UltraCal XS
- K211237 — UltraTemp Rez II
- K210550 — VALO Grand Corded and Accessory Lenses
- K190627 — VALO Grand Corded
- K173163 — ChlorCid, ChlorCid V, ChlorCid Surf
- K160551 — VALO Grand
- K152064 — Astringedent Clear
- K151094 — Mosaic Universal Composite
- K131357 — PEAK Z
- K123215 — VISCOSTAT CLEAR
- K112517 — ULTRASEAL XT HYDRO
- K111836 — PERMASHADE VENEER CEMENT
- K111696 — OPAL BAND CEMENT
- K111017 — CLEARTEMP
- K110582 — VALO CORDLESS
- K101245 — ULTRASEAL ID
- K100752 — PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
- K100301 — OPAL BOND FLOW
- K094006 — OPAL BOND MV
- K090355 — OPAL SEAL
- K083647 — VALO, MODEL 5919
- K080768 — ULTRATEMP FIRM, FAST AND REGULAR SET
- K080249 — FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
- K061438 — ULTRAEZ DESENSITIZING GEL
- K071106 — ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
- K071055 — OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
- K063703 — CITRIC ACID 20% SOLUTION, MODEL 329
- K063558 — PEAK SE, MODEL 5135
- K063557 — PEAK BOND, MODEL 5133
- K060335 — FILE-EZE
- K060334 — GI DENTSTAT
- K051750 — FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
- K042583 — CALC-I-OSS
- K050730 — MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
- K043119 — AMELOGEN PLUS
- K042756 — ENDOREZ
- K032625 — ORTHODONTIC COMPOSITE BRACKET SYSTEM
- K032626 — PERMAQUICK SE BONDING SYSTEM
- K032627 — ULTRADENT CITRIC ACID 10% SOLUTION
- K023042 — PQ1
- K010070 — ULTRAPAK NEHA
- K003383 — PALMLIGHT
- K000189 — PQ1
- K993846 — ULTRASEAL XT PLUS
- K994261 — ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
- K992097 — ENDOREZ
- K992380 — ENDO-EZE MOTOR AND HANDPIECE
- K983668 — MODIFICATION OF PQ1
- K981596 — ULTRAPAK E
- K980726 — ULTRA-BLASTER
- K974786 — PREPQUICK
- K974413 — PERMAFLO
- K974282 — VITALESCENCE
- K974283 — PQ 1
- K971899 — ENDO-SEAL
- K971898 — PERMALUTE, TRY-IN PASTE
- K971284 — OPALDAM
- K970113 — ULTRA-BLEND PLUS
- K970114 — ULTRACAL XS
- K964808 — SPETEMP
- K964810 — DERMADAM
- K965060 — ULTRA-ETCH STAT
- K964809 — SPETEMP EF
- K963979 — ULTRADENT UNIVERSAL DENTIN SEALANT
- K960696 — PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
- K960697 — ULTRACID AND ULTRACID F DISINFECTING SOLUTION
- K953167 — ULTRACID DISINFECTING SOLOUTION
- K953168 — ULTRACID F DISINFECTING SOLUTION
- K953526 — SEEK
- K953527 — PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
- K953525 — ULTRADENT FLOWABLE COMPOSITE
- K953524 — ULTRA-BLEND
- K951867 — PERMAQUIK BONDING PRIMER
- K951583 — PERMAQUIK BONDING PRIMER
- K951582 — ULTRADENT PORCELAIN ETCH
- K950859 — PERMASEAL
- K950860 — PERMALUTE
- K943370 — IMPULSE SEALER PRODUCT LINE
- K943372 — CALCIUM HYDROXIDE PASTE
- K943373 — PERMAGEN F/DC
- K941065 — DEOX, OXYGEN BARRIER VISCOUS SOLUTION
- K940860 — CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
- K934415 — FILE-EZE
- K932227 — AMELOGEN RESTORATIVE MATERIALS
- K931867 — ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE
- K925375 — CONSEPSIS SCRUB
- K931868 — PRIMADRY PRODUCT LINE
- K931869 — ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
- K931870 — BONDING RESIN PRODUCT LINE
- K924982 — CONSEPSIS(TM)
- K921408 — LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
- K921599 — ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
- K921600 — ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
- K921407 — COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.