Recall Z-1368-2022— Ultradent Products, Inc.

Name: FDA recall Z-1368-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-01

Class II · Completed

Class II FDA medical device recall by Ultradent Products, Inc., initiated 2022-06-01. It names one FDA 510(k) clearance: K063558. Product: 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.. Reason: 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..

Recalling firm: Ultradent Products, Inc.
Classification: Class II
Status: Completed
Initiated: 2022-06-01
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K063558 — PEAK SE, MODEL 5135Ultradent Products, Inc.·cleared 2006-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.