PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER— 510(k) K904128

Name: FDA 510(k) clearance K904128
Creator: U.S. Food and Drug Administration
Published: 1990-11-09

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K904128 for PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER, Substantially Equivalent on 1990-11-09. Applicant: American Orthodontics. Device class: 1.

Clearance details

Applicant: American Orthodontics
Product code: Code KMY
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1990-09-05
Decision date: 1990-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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K924351 — GLENROE ELASTIBITE STIMULATOR1994-01-06
K925064 — RELAX-O-GUARD1993-09-13
K924975 — THE ORTHOTRAINER1993-07-08

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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.