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510(k) K935561

INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT by Bausch & Lomb, Inc. — Product Code JEQ

K935561 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
November 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Powered
Device Class
Class I
Regulation Number
872.6865
Review Panel
DE
Submission Type

Other clearances by Bausch & Lomb, Inc.

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  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K173480 — Crystalsert Lens Delivery System (December 11, 2017)
  • K151102 — Bausch + Lomb Injector System (May 22, 2015)
  • K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM (March 12, 2014)
  • K133242 — STELLARIS VISION ENHANCEMENT SYSTEM (February 14, 2014)
  • K131958 — BAUSCH & LOMB INJECTOR SYSTEM (January 9, 2014)
  • K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (January 3, 2014)
  • K132481 — EASY-LOAD LENS DELIVERY SYSTEM (December 27, 2013)

Other clearances for product code JEQ

  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (July 2, 2004)
  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K012914 — SONICWAVE SONIC PLAQUE REMOVER (October 1, 2001)
  • K970381 — POWERED TOOTHBRUSH (April 18, 1997)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K945248 — HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (January 26, 1995)

FDA data resources