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510(k) K852670

A-COMPANY ESPREE SAFETY HEADGEAR by A Company, Inc. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
June 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
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)
  • K852598 — A-COMPANY SEPARATING ELASTICS (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)

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