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510(k) K851722

1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS by Artiberia — Product Code EKC

K851722 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code EKC (Excavator, Dental, Operative), 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
July 2, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Excavator, Dental, Operative
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)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (July 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (July 2, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851723 — 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (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)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)

Other clearances for product code EKC

  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)

FDA data resources