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510(k) K851716

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

K851716 is an FDA 510(k) premarket notification submitted by Artiberia for the device "865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code EMI (File, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Artiberia has at least 10 other 510(k) clearances on record.

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)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851721 — 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (July 2, 1985)
  • K851723 — 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (July 2, 1985)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (July 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (July 2, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (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)

FDA data resources