ROK— 510(k) K012529

Substantially Equivalent

Southern Dental Industries, Ltd.

FDA 510(k) clearance K012529 for ROK, Substantially Equivalent on 2001-10-22. Applicant: Southern Dental Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Southern Dental Industries, Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2001-08-06
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensenville, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Southern Dental Industries, Ltd.

K051008 — SET2005-06-15
K012528 — ICE2001-10-22

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