SOPHOS DENTAL DIAMOND— 510(k) K943841

Substantially Equivalent

Sophos Technologic

FDA 510(k) clearance K943841 for SOPHOS DENTAL DIAMOND, Substantially Equivalent on 1994-09-16. Applicant: Sophos Technologic. Device class: 1.

Clearance details

Applicant: Sophos Technologic
Product code: Code DZP
Device class: Class 1
Regulation: 21 CFR 872.4535
Advisory panel: Dental
Date received: 1994-08-05
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZP

K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED2012-04-20
K940908 — DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS1994-08-29
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.