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510(k) K852598

A-COMPANY SEPARATING ELASTICS by A Company, Inc. — Product Code ECI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
June 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by A Company, Inc.

  • K897195 — A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (May 31, 1990)
  • K852599 — A-COMPANY ELASTOMERIC TUBING (July 31, 1985)
  • K852800 — A-COMPANY SELF-LIGATING APPLIANCE (July 31, 1985)
  • K852596 — A-COMPANY ELASTIC LIGATURE RINGS (July 31, 1985)
  • K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSER (July 31, 1985)
  • K852670 — A-COMPANY ESPREE SAFETY HEADGEAR (July 31, 1985)
  • K852597 — A-COMPANY ELASTIC ROTATION WEDGES (July 31, 1985)
  • K851878 — A COMPANY BRASS SEPARATING RINGS (June 5, 1985)
  • K851454 — A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (April 29, 1985)
  • K844067 — VANISH ORTHODONTIC BRACKET (November 23, 1984)

Other clearances for product code ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (December 1, 1997)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K940165 — ALASTIK (March 7, 1994)
  • K932298 — PRO'S NEO-LASTICS (February 14, 1994)
  • K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (February 4, 1994)