Company ยท US
Implantech Associates, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2020. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2020 | K200610 | Customized Contour Implant Implantech Associates, Inc. | FWP |
| Aug 23, 2019 | K191130 | Customized Contour Implant Implantech Associates, Inc. | FWP |
| Jul 18, 2018 | K172389 | ePTFE-Coated Auricular Implant Implantech Associates, Inc. | FZD |
| Jul 10, 2014 | K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP Implantech Associates, Inc. | FWP |
| Aug 31, 2007 | K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX Implantech Associates, Inc. | FTL |
| Nov 4, 2005 | K052505 | CALF IMPLANT, MODEL EC17-X Implantech Associates, Inc. | MIB |
| Nov 4, 2005 | K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X Implantech Associates, Inc. | MIB |
| Feb 7, 2002 | K013732 | GELZONE Implantech Associates, Inc. | MDA |
| Oct 24, 2001 | K012419 | CONFORM SHEETING, MODEL IGEL Implantech Associates, Inc. | MDA |
| Nov 24, 2000 | K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) Implantech Associates, Inc. | LZK |
| Nov 7, 1997 | K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT Implantech Associates, Inc. | LZK |
| Feb 12, 1997 | K964846 | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING Implantech Associates, Inc. | MDA |
| Oct 3, 1996 | K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT Implantech Associates, Inc. | FZE |
| Aug 19, 1996 | K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT Implantech Associates, Inc. | LZK |
| Jan 27, 1995 | K943988 | IMPLANTECH NASAL LABIAL IMPLANT Implantech Associates, Inc. | LZK |
| Oct 18, 1994 | K943644 | IMPLANTECH TEMPORAL IMPLANT Implantech Associates, Inc. | FWP |
| Aug 17, 1994 | K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II Implantech Associates, Inc. | FZE |
| Jul 18, 1994 | K942876 | IMPLANTECH DORSAL NASAL IMPLANT Implantech Associates, Inc. | FZE |
| May 12, 1993 | K925426 | RIZZO NASAL IMPLANT Implantech Associates, Inc. | FZE |
| May 6, 1992 | K921582 | FLOWERS MEDIAL MALAR IMPLANT Implantech Associates, Inc. | LZK |
| May 6, 1992 | K921581 | CHIN WAFER Implantech Associates, Inc. | FWP |
| May 6, 1992 | K921580 | BRINK PRE-MAXILLARY IMPLANT Implantech Associates, Inc. | FZE |
| Dec 19, 1991 | K914297 | K.D. CHIN IMPLANT Implantech Associates, Inc. | FWP |
| Oct 17, 1991 | K913761 | 3-D ACCUSCAN FACIAL IMPLANTS Implantech Associates, Inc. | FWP |
| Jul 1, 1991 | K911516 | HIGH PROFILE CHIN IMPLANT Implantech Associates, Inc. | FWP |
| Jul 1, 1991 | K911515 | EXTENDED MALAR IMPLANT Implantech Associates, Inc. | LZK |
| Jul 1, 1991 | K911514 | ARTICULATED CHIN IMPLANT Implantech Associates, Inc. | FWP |
| Jul 1, 1991 | K911513 | TRAPEZOIDAL MALAR IMPLANT Implantech Associates, Inc. | LZK |
| Mar 28, 1991 | K910655 | COMBINED MALAR IMPLANT Implantech Associates, Inc. | LZK |
| Jan 31, 1991 | K905268 | FLOWERS JOWL IMPLANT Implantech Associates, Inc. | FWP |
| Jan 31, 1991 | K905267 | FLOWERS CHIN IMPLANT Implantech Associates, Inc. | FWP |
| Dec 18, 1990 | K904657 | FLOWERS DORSAL COLUMELLA IMPLANT Implantech Associates, Inc. | FZE |
| Dec 18, 1990 | K904656 | FLOWERS NASAL IMPLANT Implantech Associates, Inc. | FZE |
| Aug 2, 1990 | K902941 | CURVILINEAR SILICONE CHIN IMPLANT Implantech Associates, Inc. | FWP |
| Aug 1, 1990 | K902827 | ANATOMICAL MANDIBULAR IMPLANT STYLE II Implantech Associates, Inc. | FWP |
| Aug 1, 1990 | K902826 | ANATOMICAL MANDIBULAR IMPLANT STYLE I Implantech Associates, Inc. | FWP |
| Aug 1, 1990 | K902825 | EXTENDED CHIN IMPLANT STYLE II Implantech Associates, Inc. | FWP |
| Aug 1, 1990 | K902824 | EXTENDED CHIN IMPLANT STYLE I Implantech Associates, Inc. | FWP |
| May 1, 1990 | K901662 | ANATOMICAL MALAR IMPLANT Implantech Associates, Inc. | LZK |
| Oct 27, 1989 | K895152 | BINDER SUBMALAR FACIAL IMPLANT II Implantech Associates, Inc. | LZK |
| Oct 27, 1989 | K894493 | BINDER SUBMALAR FACIAL IMPLANT Implantech Associates, Inc. | LZK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Implantech Associates Inc Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766.
Product Usage:
To be used where limb support and/or elevation is considered necessary. Terminated |
HST | None listed |
| Sep 17, 2013 | Implantech Associates Inc Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M.
To augment or reconstruct underdeveloped or traumatized mandibular region. Terminated |
FWP | K902824 |