DENT-O-CRYL ORTHODONTIC ACRYLIC— 510(k) K942667

Name: FDA 510(k) clearance K942667
Creator: U.S. Food and Drug Administration
Published: 1995-02-13

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K942667 for DENT-O-CRYL ORTHODONTIC ACRYLIC, Substantially Equivalent on 1995-02-13. Applicant: Dentauraum, Inc.. Device class: 1.

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code KMY
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1994-06-06
Decision date: 1995-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMY

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K931615 — NITE-GUIDE1995-04-14
K924351 — GLENROE ELASTIBITE STIMULATOR1994-01-06
K925064 — RELAX-O-GUARD1993-09-13
K924975 — THE ORTHOTRAINER1993-07-08
K924974 — THE TMJ APPLIANCE1993-06-23

More clearances from Dentauraum, Inc.

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K952866 — REMATITAN TITANIUM1995-07-27
K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH1995-07-27
K952870 — REMANIUM: CS & G-SOFT1995-07-27
K952865 — REMANIUM: 200,CS, 380, AND CD1995-07-26
K952868 — DENTAURUM JACKET CROWN & ROOT POSTS1995-07-19

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.