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510(k) K861424

ADAPTABLE CLASS III MASK by Great Lakes Orthodontics, Ltd. — Product Code DZB

K861424 is an FDA 510(k) premarket notification submitted by Great Lakes Orthodontics, Ltd. for the device "ADAPTABLE CLASS III MASK". The FDA issued a decision of Substantially Equivalent on May 29, 1986. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Great Lakes Orthodontics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
April 16, 1986
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 Great Lakes Orthodontics, Ltd.

  • K172765 — Smart Moves Complete (June 1, 2018)
  • K150702 — Exceed Tx (March 24, 2016)
  • K083479 — BIOCRYL X (February 27, 2009)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K040881 — METACRYL (May 25, 2004)
  • K033632 — VARIFLEX (January 21, 2004)
  • K922818 — SNORE-NO-MORE (February 9, 1994)
  • K925275 — SOFT DENTURE RELINE MATERIAL ELASTOLINE (January 11, 1993)
  • K870908 — STEADY RESIN (March 19, 1987)
  • K840805 — ORAL SAFE (March 30, 1984)

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