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510(k) K884515

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED by Gatewood and Associates, Ltd. — Product Code EKJ

K884515 is an FDA 510(k) premarket notification submitted by Gatewood and Associates, Ltd. for the device "BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED". The FDA issued a decision of Substantially Equivalent on January 10, 1989. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Gatewood and Associates, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1989
Date Received
October 27, 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 Gatewood and Associates, Ltd.

  • K884514 — FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL (November 17, 1988)

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