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510(k) K843705

MANDIBULATOR JAW POSITIONER by A Company, Inc. — Product Code DYJ

K843705 is an FDA 510(k) premarket notification submitted by A Company, Inc. for the device "MANDIBULATOR JAW POSITIONER". The FDA issued a decision of Substantially Equivalent on November 14, 1984. The device falls under product code DYJ (Retainer, Screw Expansion, Orthodontic), a Class I device regulated under 21 CFR 872.5410. A Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1984
Date Received
September 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retainer, Screw Expansion, 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)
  • K852597 — A-COMPANY ELASTIC ROTATION WEDGES (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)
  • K852596 — A-COMPANY ELASTIC LIGATURE RINGS (July 31, 1985)
  • K852599 — A-COMPANY ELASTOMERIC TUBING (July 31, 1985)
  • K851878 — A COMPANY BRASS SEPARATING RINGS (June 5, 1985)
  • K851454 — A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (April 29, 1985)

Other clearances for product code DYJ

  • K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (April 23, 1997)
  • K935154 — DENTAURUM EXPANSION SCREWS (February 3, 1994)
  • K925088 — EXPANSION SCREWS (May 22, 1993)
  • K912417 — MOLAR DISTALIZING ASSEMBLY (December 20, 1991)

FDA data resources