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510(k) K970930

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

K970930 is an FDA 510(k) premarket notification submitted by Cleft Palate Appliances, Inc. for the device "BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE". The FDA issued a decision of Substantially Equivalent on April 23, 1997. The device falls under product code DYJ (Retainer, Screw Expansion, Orthodontic), a Class I device regulated under 21 CFR 872.5410.

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)

FDA data resources