Z-0053-2021Class II

PermaFlo Flowable Composite REF-UP 948 Shade: A2 -

Name: Z-0053-2021 PermaFlo Flowable Composite REF-UP 948 Shade: A2 -
Creator: Ultradent Products, Inc.
Published: 2020-08-31
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2020-08-31 / Terminated / root cause: manufacturing process

FDA source

Ultradent Products, Inc. began a recall of PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m... on 2020-08-31. FDA classified it as Class II and gives the reason as "Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0053-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-02
Terminated: 2021-10-18
Recalling firm: Ultradent Products Inc.
Product: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On August 31, 2020, the firm sent an URGENT FIRST NOTICE PRODUCT RECALL" notification to US customers via UPS (International customer via email on September 1, 2020) informing them of the potential product contamination that may affect the performance characteristics of the product to include, micro-hardness, bond strength, and wear and may pose an increased risk of restoration failure. Customers are instructed to discontinue use of the product immediately. Customers are also instructed to: -Complete the Return Response Form enclosed with this letter and Fax 801-553-4609 or email to [email protected]. -Using the supplied shipping labels, return to Ultradent the completed form and all unused Product; and -Maintain a ledger of the patients treated with the Product, including the patients name and applicable treatment information. The Recalling Firm will send out replacement kits and issue an $100 credit to customer's accounts For questions regarding replacement product, contact Customer Service at 1-888-230-1420. For any questions regarding the recall, contact Customer Concerns at 801-553-4139.
Quantity in commerce: 412 syringes (206 kits)
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, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
Product codes and lots: Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0053-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0053-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-02

Product code EBF

K974413Class IIPermafloUltradent Products, Inc. / cleared 1998-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)