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510(k) K943841

SOPHOS DENTAL DIAMOND by Sophos Technologic — Product Code DZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1994
Date Received
August 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Diamond, Dental
Device Class
Class I
Regulation Number
872.4535
Review Panel
DE
Submission Type

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  • K893844 — 3D DENTAL DIAMOND ROTARY INSTRUMENTS (August 11, 1989)
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