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510(k) K121685

SOPROCARE by Sopro — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2013
Date Received
June 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances by Sopro

  • K223470 — C50 (December 14, 2023)
  • K103813 — SOPRO 281 (March 22, 2011)
  • K092329 — SOPIX 2 (July 20, 2010)
  • K092583 — SOPROLIFE (January 13, 2010)
  • K082796 — SOPRO 184 CAMERA (April 1, 2009)
  • K080122 — SOPRO 670 ARTHROSCOPIC PUMP (July 11, 2008)
  • K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (December 13, 2007)
  • K072912 — SOPRO 225 DUAL HALOGEN LIGHT SOURCE (November 16, 2007)
  • K070102 — SOPRO 162 CAMERA (February 20, 2007)
  • K031593 — SOPRO 61D (September 16, 2003)

Other clearances for product code NBL

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  • K223470 — C50 (December 14, 2023)
  • K221249 — L1P-1F (TRIOS 5) (September 16, 2022)
  • K183471 — IC-WHCD100 (Inspire) (July 2, 2020)
  • K171007 — Fluorescence Mode (May 3, 2018)
  • K170822 — Electronic Caries Detector (September 11, 2017)
  • K150672 — VistaCam iX Proof (January 27, 2016)
  • K112139 — THE CANARY SYSTEM (October 26, 2012)