510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874543Substantially Equivalent

Model Opo-32 Irrigation Sleeve

Allergan, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874543 is the FDA 510(k) clearance record for MODEL OPO-32 IRRIGATION SLEEVE, a class I device, cleared for Allergan, Inc. on under FDA product code EIB (Syringe, Irrigating (Dental)). FDA records list 39 510(k) clearances for Allergan, Inc., from to . As of , FDA records show no recalls naming K874543.

Clearance record

Decision date
Received
(72 days to decision)
Product code
EIB Syringe, Irrigating (Dental)
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Allergan, Inc. Post Office Box 25155, Santa Ana CA
Third party review
No

Clearances, product code EIB

Trailing 12 months

FDA records hold no clearances under product code EIB in the trailing twelve months.

FDA records show no clearances under product code EIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260