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510(k) K973876

PROPHYFLEX 2, MODEL 2012 by Kavo America — Product Code EFB

K973876 is an FDA 510(k) premarket notification submitted by Kavo America for the device "PROPHYFLEX 2, MODEL 2012". The FDA issued a decision of Substantially Equivalent on December 19, 1997. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1997
Date Received
October 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Kavo America

  • K073074 — KEY LASER III 1243 US WITH DETECT (July 10, 2008)
  • K072262 — GENTLERAY 980 DIODE LASER SYSTEM (October 26, 2007)
  • K063624 — KAVO EVEREST C-TEMP (February 8, 2007)
  • K051909 — DIAGNODENT (October 21, 2005)
  • K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (August 3, 2005)
  • K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (January 31, 2005)
  • K032081 — KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 (July 24, 2003)
  • K031868 — PROPHYPEARLS (July 9, 2003)
  • K030607 — KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND (May 2, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

Other clearances for product code EFB

  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)

FDA data resources