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510(k) K931980

STAINLESS STEEL ORTHODONTIC PRODUCTS by Ortho Organizers, Inc. — Product Code DYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1993
Date Received
April 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Material, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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Other clearances for product code DYO

  • K935152 — DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD (January 31, 1994)
  • K844034 — SONOCARE (January 23, 1985)