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510(k) K871493

DENTI-TRAY(TM) by Advanced Medical, Inc. — Product Code EKW

K871493 is an FDA 510(k) premarket notification submitted by Advanced Medical, Inc. for the device "DENTI-TRAY(TM)". The FDA issued a decision of Substantially Equivalent on June 24, 1987. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Advanced Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1987
Date Received
April 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Broach, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Advanced Medical, Inc.

  • K884919 — DISPOSABLE DOME STOCK #D-300 (January 5, 1989)
  • K760368 — MONITORING & STRESS TESTING EQUIPMENT (February 28, 1977)

Other clearances for product code EKW

  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K862523 — MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (August 1, 1986)
  • K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACH (July 12, 1983)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)
  • K800292 — ENDEX BROACH, ENDODONTIC (February 19, 1980)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)

FDA data resources