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510(k) K922806

ORMCO SPORTSGUARD by Ormco Corp. — Product Code EJF

K922806 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "ORMCO SPORTSGUARD". The FDA issued a decision of Substantially Equivalent on October 20, 1993. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ormco Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1993
Date Received
June 10, 1992
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

Other clearances by Ormco Corp.

  • K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM (December 5, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)
  • K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (February 8, 2013)
  • K121524 — INSIGNIA (August 9, 2012)
  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K101676 — CLEARARCH (September 13, 2010)
  • K081900 — TEMPORARY TOOTH REPLACEMENT (October 24, 2008)
  • K081415 — DAMON 4CLEAR (September 24, 2008)
  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • 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)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources