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510(k) K925115

AMD DENTIST AND HYGIENIST KITS by Advance Medical Designs, Inc. — Product Code EKJ

K925115 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "AMD DENTIST AND HYGIENIST KITS". The FDA issued a decision of Substantially Equivalent on July 5, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
October 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Advance Medical Designs, Inc.

  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)
  • K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel (October 25, 2017)
  • K053495 — EQUIPMENT SLUSH DRAPE (March 16, 2006)
  • K011265 — ULTRASOUND TRANSDUCER COVER (October 30, 2001)
  • K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH (September 18, 2001)
  • K011422 — SURGICAL DRAPES (July 10, 2001)
  • K003670 — PATIENT DRAPE, SURGICAL (January 26, 2001)
  • K911884 — ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES (July 5, 1994)
  • K915301 — ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK (December 11, 1992)
  • K911732 — ADVANCE DISPOSABLE CONTROL SYRINGE (September 16, 1991)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)

FDA data resources