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510(k) K831748

ENDODONTIC ROOT CANAL PLUGGER FINGER- by Union Branch — Product Code EKR

K831748 is an FDA 510(k) premarket notification submitted by Union Branch for the device "ENDODONTIC ROOT CANAL PLUGGER FINGER-". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code EKR (Plugger, Root Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Union Branch has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plugger, Root Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Union Branch

  • K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACH (July 12, 1983)

Other clearances for product code EKR

  • K060347 — B&L L-BETA, MODEL WL-B1 (June 5, 2006)
  • K042828 — OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (December 1, 2004)
  • K031664 — ELEMENTS OBTURATION UNIT (April 28, 2004)
  • K860569 — ENDODONTIC ROOT CANAL PLUGGER (March 26, 1986)
  • K791019 — MCSPADDEN CONDENSOR (August 3, 1979)

FDA data resources