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510(k) K970930

BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE by Cleft Palate Appliances, Inc. — Product Code DYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
March 13, 1997
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 for product code DYJ

  • K935154 — DENTAURUM EXPANSION SCREWS (February 3, 1994)
  • K925088 — EXPANSION SCREWS (May 22, 1993)
  • K912417 — MOLAR DISTALIZING ASSEMBLY (December 20, 1991)
  • K843705 — MANDIBULATOR JAW POSITIONER (November 14, 1984)