510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864540Substantially Equivalent

Plak Vak - Pv-10

Paul S. Barclay, D.D.S., Ltd., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864540 is the FDA 510(k) clearance record for PLAK VAK - PV-10, a class I device, cleared for Paul S. Barclay, D.D.S. , Ltd. on under FDA product code EFS (Unit, Oral Irrigation). FDA records list one 510(k) clearance for Paul S. Barclay, D.D.S. , Ltd. As of , FDA records show no recalls naming K864540.

Clearance record

Decision date
Received
(225 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Paul S. Barclay, D.D.S. , Ltd. Suite 309, Chicago IL
Third party review
No

Clearances, product code EFS

Trailing 12 months

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

FDA records show no clearances under product code EFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFS, 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