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510(k) K921999

INTERJET(TM) GINGIVAL CARE INSTRUMENT by Bausch & Lomb, Inc. — Product Code EFS

K921999 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "INTERJET(TM) GINGIVAL CARE INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 3, 1992. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1992
Date Received
April 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
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 EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)
  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (October 25, 2000)
  • K983374 — AGATHA-A-H2010 (December 23, 1998)
  • K964810 — DERMADAM (February 10, 1997)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K923711 — PERIOFLEX TIP (May 16, 1994)
  • K923937 — HYDRO FLOSS (February 25, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K923457 — SHOWERFLOSS (September 1, 1992)

FDA data resources