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510(k) K935217

LC DENTAL HAND INSTRUMENT by L.C. Dental — Product Code EKJ

K935217 is an FDA 510(k) premarket notification submitted by L.C. Dental for the device "LC DENTAL HAND INSTRUMENT". The FDA issued a decision of Substantially Equivalent on January 5, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. L.C. Dental has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
October 26, 1993
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 L.C. Dental

  • K923384 — ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED (January 11, 1993)

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