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Implantech Associates Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
41
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1063-2014Class IIGelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used wJanuary 29, 2014
Z-2211-2013Class IIDevice Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruAugust 30, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K200610Customized Contour ImplantDecember 23, 2020
K191130Customized Contour ImplantAugust 23, 2019
K172389ePTFE-Coated Auricular ImplantJuly 18, 2018
K1410273D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, July 10, 2014
K071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXAugust 31, 2007
K052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XNovember 4, 2005
K052505CALF IMPLANT, MODEL EC17-XNovember 4, 2005
K013732GELZONEFebruary 7, 2002
K012419CONFORM SHEETING, MODEL IGELOctober 24, 2001
K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)November 24, 2000
K973502IMPLANTECH CONFORM BINDER SUBMALAR IMPLANTNovember 7, 1997
K964846IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETINGFebruary 12, 1997
K962824IMPLANTECH JEJ PERI-PYRIFORM IMPLANTOctober 3, 1996
K962261IMPLANTECH WM NASAL-LABIAL IMPLANTAugust 19, 1996
K943988IMPLANTECH NASAL LABIAL IMPLANTJanuary 27, 1995
K943644IMPLANTECH TEMPORAL IMPLANTOctober 18, 1994
K941960IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE IIAugust 17, 1994
K942876IMPLANTECH DORSAL NASAL IMPLANTJuly 18, 1994
K925426RIZZO NASAL IMPLANTMay 12, 1993
K921580BRINK PRE-MAXILLARY IMPLANTMay 6, 1992