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510(k) K851727

2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA by Artiberia — Product Code EIK

K851727 is an FDA 510(k) premarket notification submitted by Artiberia for the device "2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code EIK (Carver, Wax, Dental), 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
Carver, Wax, Dental
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 EIK

  • K013993 — NEOCALEX (February 22, 2002)
  • K972642 — PERIO CONTROL II (January 26, 1998)
  • K902653 — PDS-2000 (September 13, 1990)
  • K860817 — ROOT CANAL ORGANIZER (March 17, 1986)

FDA data resources