NITE-GUIDE— 510(k) K931615

Name: FDA 510(k) clearance K931615
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

ORTHO-TAIN, Inc.

FDA 510(k) clearance K931615 for NITE-GUIDE, Substantially Equivalent on 1995-04-14. Applicant: ORTHO-TAIN, Inc.. Device class: 1.

Clearance details

Applicant: ORTHO-TAIN, Inc.
Product code: Code KMY
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1993-04-01
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K925064 — RELAX-O-GUARD1993-09-13
K924975 — THE ORTHOTRAINER1993-07-08
K924974 — THE TMJ APPLIANCE1993-06-23

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K980952 — SNORE-CURE ANTI-SNORING APPLIANCE1998-06-01

Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.