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510(k) K002886

IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) by Implantech Associates, Inc. — Product Code LZK

K002886 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)". The FDA issued a decision of Substantially Equivalent on November 24, 2000. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2000
Date Received
September 15, 2000
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 Implantech Associates, Inc.

  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K172389 — ePTFE-Coated Auricular Implant (July 18, 2018)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX (August 31, 2007)
  • K052505 — CALF IMPLANT, MODEL EC17-X (November 4, 2005)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)
  • K013732 — GELZONE (February 7, 2002)
  • K012419 — CONFORM SHEETING, MODEL IGEL (October 24, 2001)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • 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)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)

FDA data resources