Data / Medical devices / United States / Implantech Associates, Inc.
Implantech Associates, Inc.: FDA-registered device maker in Ventura, CA, United States, 62 510(k) clearances
Implantech Associates, Inc. is registered with the FDA (registration 2028924) in Ventura, CA, United States. It lists 18 device types. The FDA files 62 510(k) clearances under its listings, the newest dated December 23, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2028924
- FEI number
- 1000142697
- Address
- 6025 Nicolle ST., Suite B, Ventura, CA, United States, 93003
- Owner or operator
- IMPLANTECH ASSOCIATES, INC. (9000198)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- September 20, 2002
- Registered through
- 2026
- Brand names listed
- 3D Accuscan Patient-Specific® Implant, Allied Biomedical® Malar Implant, Allied Biomedical® Nasal Implant, Allied Biomedica® Chin Implant, AlliedSIl Silicone Tubing, AlliedSil Sheeting, Anatomical Chin, Anatomical Malar I and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2020 | K200610 | Customized Contour Implant | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| July 18, 2018 | K172389 | ePTFE-Coated Auricular Implant | FZD | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| July 10, 2014 | K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 31, 2007 | K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | FTL | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| November 4, 2005 | K052505 | CALF IMPLANT, MODEL EC17-X | MIB | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| November 4, 2005 | K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | MIB | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| February 7, 2002 | K013732 | GELZONE | MDA | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| November 24, 2000 | K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| October 13, 1998 | K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | MIB | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| August 5, 1998 | K982051 | KELOCATE SHEETING | MDA | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| May 6, 1998 | K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| May 6, 1998 | K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| May 6, 1998 | K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| May 6, 1998 | K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| May 6, 1998 | K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| April 3, 1998 | K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| March 4, 1998 | K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | FWP | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| March 3, 1998 | K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| March 3, 1998 | K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| March 3, 1998 | K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| November 7, 1997 | K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| July 18, 1997 | K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | FZE | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| July 18, 1997 | K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | LZK | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| July 18, 1997 | K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | FWP | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| May 28, 1997 | K971480 | DURALASTIC I AND DURALASTIC II | MIB | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| October 3, 1996 | K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| January 26, 1996 | K955433 | DURALASTIC SILICONE TUBING | KGZ | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| November 29, 1995 | K954413 | KELOCOTE | MDA | Substantially Equivalent | Allied Biomedical Corp. | accessdata.fda.gov |
| November 29, 1995 | K954382 | PROLASTIC SHEETING | MIB | Substantially Equivalent | Pillar Surgical | accessdata.fda.gov |
| August 28, 1995 | K952708 | PECTORALIS IMPLANT | FZE | Substantially Equivalent | Spirit Ridge Technologies | accessdata.fda.gov |
| August 28, 1995 | K952706 | SPIRIT RIDGE SILICONE CARVING BLOCK | FZE | Substantially Equivalent | Spirit Ridge Technologies | accessdata.fda.gov |
| February 7, 1995 | K945998 | CHIN IMPLANT STYLE I | FWP | Substantially Equivalent | King & Spalding | accessdata.fda.gov |
| January 27, 1995 | K943988 | IMPLANTECH NASAL LABIAL IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| November 7, 1994 | K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT | MIC | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| November 4, 1994 | K944166 | DORSAL COLUMELLA IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| November 4, 1994 | K944165 | SILHOUETTE MALAR IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| November 4, 1994 | K944164 | MENISCUS CHIN IMPLANT | LZK | Substantially Equivalent | Spectrum Designs, Inc. | accessdata.fda.gov |
| October 18, 1994 | K943644 | IMPLANTECH TEMPORAL IMPLANT | FWP | Substantially Equivalent - Subject to Tracking Reg. | Implantech Associates, Inc. | accessdata.fda.gov |
| August 17, 1994 | K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 8, 1994 | K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | LZK | Substantially Equivalent | King & Spalding | accessdata.fda.gov |
| July 18, 1994 | K942876 | IMPLANTECH DORSAL NASAL IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| January 10, 1994 | K931548 | INAMED DEVELOPMENT ASPIRATION TIP | GCX | Substantially Equivalent | Inamed Development Co. | accessdata.fda.gov |
| May 12, 1993 | K925426 | RIZZO NASAL IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| May 6, 1992 | K921582 | FLOWERS MEDIAL MALAR IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| May 6, 1992 | K921581 | CHIN WAFER | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| May 6, 1992 | K921580 | BRINK PRE-MAXILLARY IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| April 21, 1992 | K913882 | ZARA SILICONE BLOCK | MIB | Substantially Equivalent | Byron Medical | accessdata.fda.gov |
| July 1, 1991 | K911516 | HIGH PROFILE CHIN IMPLANT | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| July 1, 1991 | K911513 | TRAPEZOIDAL MALAR IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| March 28, 1991 | K910655 | COMBINED MALAR IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| January 31, 1991 | K905268 | FLOWERS JOWL IMPLANT | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| January 31, 1991 | K905267 | FLOWERS CHIN IMPLANT | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| December 18, 1990 | K904657 | FLOWERS DORSAL COLUMELLA IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| December 18, 1990 | K904656 | FLOWERS NASAL IMPLANT | FZE | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 2, 1990 | K902941 | CURVILINEAR SILICONE CHIN IMPLANT | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 1, 1990 | K902827 | ANATOMICAL MANDIBULAR IMPLANT STYLE II | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 1, 1990 | K902826 | ANATOMICAL MANDIBULAR IMPLANT STYLE I | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 1, 1990 | K902825 | EXTENDED CHIN IMPLANT STYLE II | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| August 1, 1990 | K902824 | EXTENDED CHIN IMPLANT STYLE I | FWP | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| May 1, 1990 | K901662 | ANATOMICAL MALAR IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| October 27, 1989 | K895152 | BINDER SUBMALAR FACIAL IMPLANT II | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
| October 27, 1989 | K894493 | BINDER SUBMALAR FACIAL IMPLANT | LZK | Substantially Equivalent | Implantech Associates, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 29, 2014 | 67446 | Class II | Terminated | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. | Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure. | accessdata.fda.gov |
| August 30, 2013 | 66208 | Class II | Terminated | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Malar
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Elastomer, Silicone Block
- All makers of Prosthesis, Chin, Internal
- All makers of Prosthesis, Nose, Internal
- All makers of Retention Device, Suture
Updated December 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.