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510(k) K093721

COSP2 by 3M Espe AG Dental Products — Product Code MVL

K093721 is an FDA 510(k) premarket notification submitted by 3M Espe AG Dental Products for the device "COSP2". The FDA issued a decision of Substantially Equivalent on February 19, 2010. The device falls under product code MVL (Cord, Retraction), a Class U device. 3M Espe AG Dental Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2010
Date Received
December 2, 2009
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 3M Espe AG Dental Products

  • K100908 — UNICEM HM (June 22, 2010)
  • K100756 — MALTA (June 2, 2010)
  • K094007 — UNICEM (April 8, 2010)
  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K080514 — PECD-01 AND PECD QUICK-01 (March 26, 2008)
  • K072055 — LAVA FRAME, LAVA FRAME SHADE (February 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)
  • K071260 — HERMES BOND 3 (July 17, 2007)

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