Food, drugs, devices › Ultradent Products, Inc.

Device recall: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow

FDA enforcement event 86432 · Class II · initiated 31 Aug 2020 · status Terminated · terminated 18 Oct 2021

DeviceVoluntary: Firm initiated1 product recordSouth Jordan, UT

Ultradent Products, Inc. (South Jordan, UT) initiated this device recall on 31 Aug 2020; FDA lists 1 product record under event 86432, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 18 Oct 2021. Initiation: voluntary: firm initiated. Ultradent Products, Inc. has 15 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ultradent Products, Inc., South Jordan, UT.

Reason for recall

"Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous."

Distribution

"Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
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.	412 syringes (206 kits)	Class II	Terminated	14 Oct 2020

Context

93%of 2020 device events are Class II916 events that year

1product record in this eventfirm median: 1

15events on this register for the firm

Other enforcement events for Ultradent Products, Inc.

Initiated	Product (first record)	Type	Class	Records
28 Jan 2026	Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.	Device	Class II	1
2 Aug 2024	Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Produ	Device	Class II	3
1 Jun 2022	Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime	Device	Class II	1
12 Jul 2018	Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit	Device	Class II	1
4 Aug 2017	Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used	Device	Class II	5
14 Dec 2016	NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless	Device	Class II	1
17 Nov 2016	UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus i	Device	Class II	1
22 Dec 2015	InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard	Device	Class II	1
19 Nov 2013	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in	Device	Class III	1
8 Mar 2013	Opalescence Treswhite Supreme Peach Patient Kit	Food	Class III	1

All 15 events for Ultradent Products, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 18 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.