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510(k) K931742

INJECT-R FILL by Union Broach, Div. Moyco Industries, Inc. — Product Code EKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
April 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
Review Panel
DE
Submission Type

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  • K940260 — THERMAL PULP TESTER (March 7, 1994)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
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  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K855136 — FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE (March 6, 1986)
  • K852474 — UNION BROACH BLEACHING LIGHT (July 1, 1985)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)

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