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510(k) K904094

C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE by Lancer Orthodontics, Inc. — Product Code EJF

K904094 is an FDA 510(k) premarket notification submitted by Lancer Orthodontics, Inc. for the device "C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Lancer Orthodontics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
September 6, 1990
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 Lancer Orthodontics, Inc.

  • K122069 — STORM MINI SCREW (April 11, 2013)
  • 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)
  • K904089 — PERMA MESH (November 2, 1990)
  • K902075 — INTRIGUE CERAMIC BRACKET (August 6, 1990)

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