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510(k) K883322

DENTAL HAND INSTRUMENTS by Collagen Corp. — Product Code EKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
August 5, 1988
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 Collagen Corp.

  • K904671 — QAR HANDPIECE (December 21, 1990)
  • K904228 — OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) (November 9, 1990)
  • K901600 — OSSEOTITE IRRIGATION UNIT (June 21, 1990)
  • K900275 — OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET (April 19, 1990)
  • K895462 — OSSEODENT DENTAL ATTACHMENTS (April 4, 1990)
  • K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (March 28, 1990)
  • K894331 — OSSEODENT SURGICAL KIT (October 4, 1989)
  • K812617 — VITROGEN TM 100 (October 2, 1981)

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)