Food, drugs, devices › Ultradent Products, Inc.

Device recall: Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used

FDA enforcement event 77891 · Class II · initiated 4 Aug 2017 · status Terminated · terminated 4 Jan 2018

DeviceVoluntary: Firm initiated5 product recordsSouth Jordan, UT

FDA enforcement event 77891 is a device recall by Ultradent Products, Inc. of South Jordan, UT, initiated 4 Aug 2017 and classified Class II, with 5 product records.

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 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 4 Jan 2018. 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

"The barcode label was placed underneath the sterile barrier and the product was re-wrapped."

Distribution

"Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-3214-2017	Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 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.	61 units	Class II	Terminated	4 Oct 2017
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.	95 units	Class II	Terminated	4 Oct 2017
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.	210 units	Class II	Terminated	4 Oct 2017
Z-3217-2017	Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 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..	26 units	Class II	Terminated	4 Oct 2017
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..	62 units	Class II	Terminated	4 Oct 2017

Context

93%of 2017 device events are Class II1,091 events that year

5product records 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
31 Aug 2020	PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow	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
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: "The barcode label was placed underneath the sterile barrier and the product was re-wrapped."

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: "Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Jan 2018. "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.