510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952218Substantially Equivalent

Jt-3 Electrognathograph

Bio-Research Associates, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952218 is the FDA 510(k) clearance record for JT-3 ELECTROGNATHOGRAPH, a class I device, cleared for Bio-Research Associates, Inc. on under FDA product code NFS (Device, Jaw Tracking, For Monitoring Jaw Positions). FDA records list 10 510(k) clearances for Bio-Research Associates, Inc., from to . As of , FDA records show no recalls naming K952218.

Clearance record

Decision date
Received
(133 days to decision)
Product code
NFS Device, Jaw Tracking, For Monitoring Jaw Positions
Regulation
21 CFR 872.2060
Device class
Class I
Review panel
Dental
Applicant
Bio-Research Associates, Inc. 4113 N. Port Washington Rd., Milwaukee WI
510(k) summary
Statement
Third party review
No

Clearances, product code NFS

Trailing 12 months

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

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