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510(k) K902653

PDS-2000 by Intl. Equipment and Supply Corp. — Product Code EIK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1990
Date Received
June 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carver, Wax, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K860817 — ROOT CANAL ORGANIZER (March 17, 1986)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)