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510(k) K141221

LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR by Lares Research, Inc. — Product Code EFB

K141221 is an FDA 510(k) premarket notification submitted by Lares Research, Inc. for the device "LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR". The FDA issued a decision of Substantially Equivalent on October 28, 2014. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Lares Research, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2014
Date Received
May 12, 2014
Clearance Type
Abbreviated
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 Lares Research, Inc.

  • K220873 — Perceptive electric dental motor and control unit (December 15, 2022)
  • K220874 — Smooth Drive contra angle and straight handpieces (November 7, 2022)
  • K031540 — APEX ELECTRIC HANDPIECE SYSTEM (June 30, 2003)
  • K011960 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S (December 21, 2001)
  • K983524 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) (April 1, 1999)
  • K961163 — LARES RESEARCH AS-1 LOWSPEED HANDPIECE (April 23, 1996)
  • K905542 — LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS (March 11, 1991)
  • K905543 — LARES APOLLO CS/CP/C (March 11, 1991)
  • K905541 — LARES 757 WORKHORSE HIGHSPEED HANDPIECE (March 7, 1991)

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