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510(k) K901958

GUARDIAN SAFE BOW by Lancer Orthodontics, Inc. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1990
Date Received
May 1, 1990
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 Lancer Orthodontics, Inc.

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  • K071192 — BLUGOO HD (June 22, 2007)
  • K051552 — O.A.S.I. SYSTEM (September 19, 2005)
  • K991481 — PARAGON (August 11, 1999)
  • K904090 — ORTHODONTIC BONDING ADHESIVE CONTROL (April 29, 1991)
  • K904092 — LANCER ORIGINAL, SIERRA, GENERAL PURPOSE (November 9, 1990)
  • K904093 — BUCCAL TUBE, BUCCAL ATTACHMENT (November 7, 1990)
  • K904091 — TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (November 5, 1990)
  • K904094 — C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (November 2, 1990)
  • K904089 — PERMA MESH (November 2, 1990)

Other clearances for product code DZB

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  • 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)