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510(k) K852179

CERAMIC ORTHODONIT APPLIANCE by Gac Intl., Inc. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
May 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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Other clearances for product code EJF

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  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)