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510(k) K000358

MULTI ADJUSTABLE FACE MASK by Ortho Technology — Product Code DZB

K000358 is an FDA 510(k) premarket notification submitted by Ortho Technology for the device "MULTI ADJUSTABLE FACE MASK". The FDA issued a decision of Substantially Equivalent on June 9, 2000. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Ortho Technology has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2000
Date Received
February 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

Other clearances by Ortho Technology

  • K112707 — GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM (January 13, 2012)
  • K073045 — SAPPHIRE CERAMIC BRACKET (December 18, 2007)
  • K051751 — EQUA-PULL SAFETY RELEASE MODULE (July 22, 2005)

Other clearances for product code DZB

  • K202855 — Orthodontic Facemask (June 21, 2021)
  • K162543 — Reverse Pull Adjustable Facemask (August 28, 2017)
  • K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-P (October 3, 2011)
  • K103019 — KJ MASK (June 9, 2011)
  • K052553 — NITOM LOCKING FACEBOW (December 22, 2005)
  • K051751 — EQUA-PULL SAFETY RELEASE MODULE (July 22, 2005)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K032392 — MORALES PROTRACTION FACEMASK (October 22, 2003)
  • K993224 — T-GEAR, MODEL TG/400-700 (February 11, 2000)
  • K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (September 4, 1998)

FDA data resources