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510(k) K101756

TSC by Kerr Corporation — Product Code MVL

K101756 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "TSC". The FDA issued a decision of Substantially Equivalent on October 26, 2010. The device falls under product code MVL (Cord, Retraction), a Class U device. Kerr Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2010
Date Received
June 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Kerr Corporation

  • K252890 — ZenSeal Pro (January 7, 2026)
  • K222830 — Rainbow 360 (January 12, 2023)
  • K221255 — SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (August 31, 2022)
  • K191548 — Nexus Universal Self-Cure (October 11, 2019)
  • K182162 — OptiBond eXTRa Universal (November 7, 2018)
  • K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retra (August 8, 2017)
  • K163064 — Demi Ultra (July 18, 2017)
  • K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminu (February 3, 2017)
  • K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retractio (January 13, 2017)
  • K162436 — EndoVac Pure (December 21, 2016)

Other clearances for product code MVL

  • K254239 — CyClean Cord (March 27, 2026)
  • K253797 — One-Stop (February 27, 2026)
  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)

FDA data resources