510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931615Substantially Equivalent

Nite-Guide

Ortho-Tain, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931615 is the FDA 510(k) clearance record for NITE-GUIDE, a class I device, cleared for ORTHO-TAIN, Inc. on under FDA product code KMY (Positioner, Tooth, Preformed). FDA records list 2 510(k) clearances for ORTHO-TAIN, Inc., from to . As of , FDA records show no recalls naming K931615.

Clearance record

Decision date
Received
(743 days to decision)
Product code
KMY Positioner, Tooth, Preformed
Regulation
21 CFR 872.5525
Device class
Class I
Review panel
Dental
Applicant
ORTHO-TAIN, Inc. 85th Floor Sears Tower, Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code KMY

Trailing 12 months

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

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