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510(k) K771095

J HOOK HEADGEAR by Northwest Orthodontics, Inc. — Product Code DZB

K771095 is an FDA 510(k) premarket notification submitted by Northwest Orthodontics, Inc. for the device "J HOOK HEADGEAR". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Northwest Orthodontics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
June 20, 1977
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 Northwest Orthodontics, Inc.

  • K800748 — SNAP-WAY HEADGEAR (April 10, 1980)
  • K790843 — SNAP-WAY (May 31, 1979)
  • K780814 — SAFETY STOP NECKSTRAP (June 30, 1978)
  • K780747 — SNAP-WAY (May 26, 1978)
  • K771706 — SAIF-BOW (September 20, 1977)

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)
  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
  • K993224 — T-GEAR, MODEL TG/400-700 (February 11, 2000)

FDA data resources