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510(k) K932255

YOUNG D'GRANULATOR by Young Dental Manufacturing Co. 1, LLC — Product Code KMW

K932255 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "YOUNG D'GRANULATOR". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
May 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Young Dental Manufacturing Co. 1, LLC

  • K241041 — Silver Fluoride Hypersensitivity Varnish (February 28, 2025)
  • K201127 — DEFEND Ear-loop Face Masks (April 14, 2021)
  • K171377 — Young INFINITY Cordless Handpiece System (August 20, 2018)
  • K153334 — Oral-B 5% Sodium Fluoride Varnish (May 20, 2016)
  • K903284 — YOUNG PROPHY SYSTEM, PS UNIT (December 17, 1990)
  • K875340 — JETPOLISHER(TM) (June 10, 1988)
  • K875339 — JETPOLISHER AIRPOLISHING POWDER (April 18, 1988)
  • K821484 — DAWN LOW SPEED HANDPIECE SYSTEM (June 9, 1982)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)
  • K790722 — PROPHYLAXIS ANGLE (June 15, 1979)

Other clearances for product code KMW

  • K211584 — Oral Surgery Contra (August 19, 2021)
  • K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece (November 21, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (July 29, 2008)
  • K994298 — FRIOS MICROSAW (February 18, 2000)
  • K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES (June 27, 1997)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K862110 — OSSEODENT DRILLING SYSTEM (August 7, 1986)

FDA data resources