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510(k) K874964

DENTAL HAND INSTRUMENTS by Solway, Inc. — Product Code EKJ

K874964 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "DENTAL HAND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 2, 1987
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 Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)

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