PREFORMED TEMPLATE FOR TOOTH POSITIONER— 510(k) K891328

Name: FDA 510(k) clearance K891328
Creator: U.S. Food and Drug Administration
Published: 1989-03-31

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K891328 for PREFORMED TEMPLATE FOR TOOTH POSITIONER, Substantially Equivalent on 1989-03-31. 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: 1989-03-10
Decision date: 1989-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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K931615 — NITE-GUIDE1995-04-14
K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC1995-02-13
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.