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510(k) K801463

OJ-1 ENDODONIC ROOT CANAL FILE HOLDER by Almore Intl., Inc. — Product Code EKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preparer, Root Canal Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

Other clearances for product code EKQ

  • K832378 — VIBRATORY ENDODONTIC SYSTEM (October 4, 1983)