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510(k) K223470

C50 by Sopro — Product Code NBL

K223470 is an FDA 510(k) premarket notification submitted by Sopro for the device "C50". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Sopro has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
November 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light-Induced Fluorescence Caries Detector
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances by Sopro

  • K121685 — SOPROCARE (March 12, 2013)
  • 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

  • K252464 — Surgical Microscope (OMS2360, OMS2380) (April 28, 2026)
  • K242103 — TRIOS Ready Tip (April 4, 2025)
  • K221275 — Qraycam PRO (September 4, 2024)
  • K231722 — SmarTooth (May 1, 2024)
  • 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)
  • K121685 — SOPROCARE (March 12, 2013)

FDA data resources