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510(k) K060347

B&L L-BETA, MODEL WL-B1 by B&L Biotech Co., Ltd. — Product Code EKR

K060347 is an FDA 510(k) premarket notification submitted by B&L Biotech Co., Ltd. for the device "B&L L-BETA, MODEL WL-B1". The FDA issued a decision of Substantially Equivalent on June 5, 2006. The device falls under product code EKR (Plugger, Root Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2006
Date Received
February 10, 2006
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 for product code EKR

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

FDA data resources