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510(k) K934981

DENTAL DRILL by Eare Consulting Service — Product Code DZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
October 19, 1993
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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  • K901262 — F.G. LASER (DENTAL BUR) (July 9, 1990)
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  • K893844 — 3D DENTAL DIAMOND ROTARY INSTRUMENTS (August 11, 1989)
  • K885233 — NOVA DIAMOND (February 13, 1989)