510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972642Substantially Equivalent

Perio Control II

Estrad B.V., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972642 is the FDA 510(k) clearance record for PERIO CONTROL II, a class I device, cleared for Estrad B.V. on under FDA product code EIK (Carver, Wax, Dental). FDA records list one 510(k) clearance for Estrad B.V. As of , FDA records show no recalls naming K972642.

Clearance record

Decision date
Received
(195 days to decision)
Product code
EIK Carver, Wax, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Estrad B.V. P.O. Box 7007, Deer Field IL
510(k) summary
Summary
Third party review
No

Clearances, product code EIK

Trailing 12 months

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

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