510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896364Substantially Equivalent

Decident

Nevin Laboratories, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896364 is the FDA 510(k) clearance record for DECIDENT, a class I device, cleared for Nevin Laboratories, Inc. on under FDA product code EKY (Handpiece, Water-Powered). FDA records list one 510(k) clearance for Nevin Laboratories, Inc. As of , FDA records show no recalls naming K896364.

Clearance record

Decision date
Received
(255 days to decision)
Product code
EKY Handpiece, Water-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Nevin Laboratories, Inc. 5000 S. Halsted St., Chicago IL
Third party review
No

Clearances, product code EKY

Trailing 12 months

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

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