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510(k) K902284

ZYMALAR IMPLANT by Applied Biomaterial Technologies — Product Code LZK

K902284 is an FDA 510(k) premarket notification submitted by Applied Biomaterial Technologies for the device "ZYMALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Applied Biomaterial Technologies has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
May 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Applied Biomaterial Technologies

  • K935571 — DURALASTIC SHEETING (January 31, 1995)
  • K945552 — DURALASTIC SHEETING (January 31, 1995)
  • K931500 — THE PERMARIDGE MATRIX CHIN (November 17, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)
  • K902285 — THE MAGNUM CHIN IMPLANT (September 12, 1990)
  • K902283 — THE NAUTILUS NASAL IMPLANT (August 14, 1990)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources