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510(k) K925088

EXPANSION SCREWS by Forestadent — Product Code DYJ

K925088 is an FDA 510(k) premarket notification submitted by Forestadent for the device "EXPANSION SCREWS". The FDA issued a decision of Substantially Equivalent on May 22, 1993. The device falls under product code DYJ (Retainer, Screw Expansion, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Forestadent has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1993
Date Received
October 7, 1992
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 Forestadent

  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

Other clearances for product code DYJ

  • K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (April 23, 1997)
  • K935154 — DENTAURUM EXPANSION SCREWS (February 3, 1994)
  • K912417 — MOLAR DISTALIZING ASSEMBLY (December 20, 1991)
  • K843705 — MANDIBULATOR JAW POSITIONER (November 14, 1984)

FDA data resources