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510(k) K931980

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

K931980 is an FDA 510(k) premarket notification submitted by Ortho Organizers, Inc. for the device "STAINLESS STEEL ORTHODONTIC PRODUCTS". The FDA issued a decision of Substantially Equivalent on September 1, 1993. The device falls under product code DYO (Band, Material, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ortho Organizers, Inc. has at least 7 other 510(k) clearances on record.

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

Other clearances by Ortho Organizers, Inc.

  • K252760 — Carriere® Motion Pro® Clear Bite Corrector (November 27, 2025)
  • K173440 — Carriere SLX 3D Clear (March 8, 2018)
  • K160720 — Carriere Motion Clear Class II (November 28, 2016)
  • K110335 — CERAMIC BRACKETS (May 19, 2011)
  • K061266 — ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR (July 31, 2006)
  • K923218 — NITANIUM PALATAL EXPANDER (September 13, 1993)
  • K931663 — NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL (July 8, 1993)

Other clearances for product code DYO

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

FDA data resources