Recall Z-0285-2024— Young Dental Manufacturing I, LLC

Name: FDA recall Z-0285-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-06

Class II · Ongoing

Class II FDA medical device recall by Young Dental Manufacturing I, LLC, initiated 2023-10-06. It names one FDA 510(k) clearance: K780752. Product: CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles. Reason: one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs..

Recalling firm: Young Dental Manufacturing I, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-10-06
Firm location: Earth City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K780752 — PROPHYLAXIS ANGLEYoung Dental Manufacturing Co. 1, LLC·cleared 1978-05-26

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

CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

Reason for recall

one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

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