DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS— 510(k) K940908

Name: FDA 510(k) clearance K940908
Creator: U.S. Food and Drug Administration
Published: 1994-08-29

Substantially Equivalent

Dunhall Pharmaceuticals, Inc.

FDA 510(k) clearance K940908 for DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS, Substantially Equivalent on 1994-08-29. Applicant: Dunhall Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Dunhall Pharmaceuticals, Inc.
Product code: Code DZP
Device class: Class 1
Regulation: 21 CFR 872.4535
Advisory panel: Dental
Date received: 1994-02-24
Decision date: 1994-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gravette, AR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZP

view all

K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED2012-04-20
K943841 — SOPHOS DENTAL DIAMOND1994-09-16
K934981 — DENTAL DRILL1994-02-03
K923757 — DENTAL DIAMOND DRILLS1993-03-16
K913651 — MANI DIA-BURS1992-01-14

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