Medical Device Manufacturer · US , Washington , DC

Implantech Associates, Inc.

41 submissions · 40 cleared · Since 1989
41
Total
40
Cleared
0
Denied

Implantech Associates, Inc. — FDA 510(k) Submissions

Implantech Associates, Inc. has submitted 41 FDA 510(k) premarket notifications since 1989, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Chin, Internal, Implant, Malar, Prosthesis, Nose, Internal, Elastomer, Silicone, For Scar Management, Elastomer, Silicone Block . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
Customized Contour Implant
K200610 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Dec 2020 289d
Customized Contour Implant
K191130 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Aug 2019 116d
ePTFE-Coated Auricular Implant
K172389 · FZD Prosthesis, Ear, Internal · General & Plastic Surgery
Jul 2018 344d
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
K141027 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Jul 2014 79d
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Aug 2007 94d
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Nov 2005 52d
CALF IMPLANT, MODEL EC17-X
K052505 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Nov 2005 52d
GELZONE
K013732 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Feb 2002 90d
CONFORM SHEETING, MODEL IGEL
K012419 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Oct 2001 86d
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · LZK Implant, Malar · General & Plastic Surgery
Nov 2000 70d
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · LZK Implant, Malar · General & Plastic Surgery
Nov 1997 52d
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Feb 1997 71d
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K962824 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Oct 1996 76d
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · LZK Implant, Malar · General & Plastic Surgery
Aug 1996 68d
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · LZK Implant, Malar · General & Plastic Surgery
Jan 1995 164d
IMPLANTECH TEMPORAL IMPLANT
K943644 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Oct 1994 83d
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Aug 1994 117d
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Jul 1994 31d
RIZZO NASAL IMPLANT
K925426 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
May 1993 197d
BRINK PRE-MAXILLARY IMPLANT
K921580 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
May 1992 34d
CHIN WAFER
K921581 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1992 34d
FLOWERS MEDIAL MALAR IMPLANT
K921582 · LZK Implant, Malar · General & Plastic Surgery
May 1992 34d
K.D. CHIN IMPLANT
K914297 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Dec 1991 85d
3-D ACCUSCAN FACIAL IMPLANTS
K913761 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Oct 1991 57d
TRAPEZOIDAL MALAR IMPLANT
K911513 · LZK Implant, Malar · General & Plastic Surgery
Jul 1991 88d
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