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510(k) K851716

865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES by Artiberia — Product Code EMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Bone, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Artiberia

  • K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (August 29, 1985)
  • K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (July 9, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (July 2, 1985)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K851729 — 2620/1 TO 2635/2 VARIOUS DENTAL CROWN SCISSORS (July 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (July 2, 1985)
  • K851721 — 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (July 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)

Other clearances for product code EMI

  • K914035 — MINI-MILL (March 2, 1992)
  • K912989 — PLANUSTAR AND DENS NOBILIS DENTURE TEETH (August 16, 1991)
  • K823676 — DISC NEEDLE SET #TX-8220 (January 9, 1983)