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510(k) K031664

ELEMENTS OBTURATION UNIT by Sybron Endo/Analytic — Product Code EKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2004
Date Received
May 29, 2003
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 Sybron Endo/Analytic

  • K021253 — ULTRASONIC TIPS WITH DIAMOND COATING (July 5, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)

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)
  • K860569 — ENDODONTIC ROOT CANAL PLUGGER (March 26, 1986)
  • K831748 — ENDODONTIC ROOT CANAL PLUGGER FINGER- (July 12, 1983)
  • K791019 — MCSPADDEN CONDENSOR (August 3, 1979)