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510(k) K851454

A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS by A Company, Inc. — Product Code ECQ

K851454 is an FDA 510(k) premarket notification submitted by A Company, Inc. for the device "A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code ECQ (Aligner, Bracket, Orthodontic), a Class I device regulated under 21 CFR 872.4565. A Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
April 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aligner, Bracket, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by A Company, Inc.

  • K897195 — A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (May 31, 1990)
  • K852596 — A-COMPANY ELASTIC LIGATURE RINGS (July 31, 1985)
  • K852597 — A-COMPANY ELASTIC ROTATION WEDGES (July 31, 1985)
  • K852599 — A-COMPANY ELASTOMERIC TUBING (July 31, 1985)
  • K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSER (July 31, 1985)
  • K852598 — A-COMPANY SEPARATING ELASTICS (July 31, 1985)
  • K852800 — A-COMPANY SELF-LIGATING APPLIANCE (July 31, 1985)
  • K852670 — A-COMPANY ESPREE SAFETY HEADGEAR (July 31, 1985)
  • K851878 — A COMPANY BRASS SEPARATING RINGS (June 5, 1985)
  • K844067 — VANISH ORTHODONTIC BRACKET (November 23, 1984)

Other clearances for product code ECQ

  • K935153 — DENTAURUM BRACKET POSITIONING GAUGE (January 31, 1994)

FDA data resources