Is this your brand? Sign in to claim ownership.
Sign in to claim this brandImplantech Associates, Inc.
United States·US-MF-000008458
Last updated September 17, 2026
What Implantech Associates, Inc. makes
Implantech Associates, Inc. manufactures silicone-based reconstructive materials and prostheses for facial and external ear reconstruction, including chin, nasal cartilage support, malar, and mandibular prostheses. Their portfolio also includes reusable scar-management dressings and non-sterile silicone sheets for tissue reconstruction. Customizable silicone blocks and pre-shaped implants are designed for surgical applications in head and neck reconstruction.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIb, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Implantech Associates, Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Implantech Associates, Inc. primarily manufacture?
Implantech Associates, Inc. specializes in silicone-based reconstructive materials and prostheses. Their devices include facial prostheses like chin, nasal cartilage support, malar, and mandibular implants, as well as external ear prostheses. They also produce reusable scar-management dressings and non-sterile silicone sheets for tissue reconstruction. Many of their products are customizable silicone blocks or pre-shaped implants designed for surgical use in head and neck reconstruction.
Where is Implantech Associates, Inc. based, and how does that affect their regulatory listings?
Implantech Associates, Inc. is headquartered in the United States. Because of this, their devices are listed in the FDA’s Unique Device Identifier (UDI) system, which is a requirement for U.S.-based manufacturers. Additionally, their devices appear in the EU’s eudamed database, indicating they are also marketed or intended for use in the European Economic Area, where eudamed registration is mandatory for medical devices.
Which regulatory registries list Implantech Associates, Inc.’s devices, and why?
Implantech Associates, Inc.’s devices are listed in two key regulatory registries: the FDA’s Unique Device Identifier (UDI) system and the EU’s eudamed database. The UDI listing is required for devices marketed in the U.S. under FDA regulations, ensuring traceability and compliance. The eudamed listing is mandatory for devices placed on the EU market, as it facilitates transparency and regulatory oversight in the European Economic Area.
How are Implantech Associates, Inc.’s devices classified under FDA regulations?
Implantech Associates, Inc.’s devices fall into three FDA classification categories: Class I, Class II, and Class IIb. Class I devices generally pose the lowest risk and may have fewer regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. Class IIb devices are more complex and carry higher risks, necessitating stricter regulatory scrutiny. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, as outlined in FDA’s regulatory framework.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6025, Nicolle Street, Ventura, United States
- Website
- www.implantech.com
- —
- —
- [email protected]
- Phone
- 805-339-9415 x601
- PRRC Contact
- Craig Arthur
- EUDAMED SRN
- US-MF-000008458
- FDA FEI Number
- 1000142697
- DUNS Number
- —
Catalogue (1430)
Page 3 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chin Implant | Style 3 / Size 1 | FDA UDI | Class II | Active |
| Lateral Mandibular Angle™ | Size: 4/10, Left | FDA UDI | Class II | Unknown |
| Binder Submalar® II | Size: Large | FDA UDI | Class II | Active |
| AlliedSil™ Sheeting | Size: 203.2mm x 152.4mm x 1.524mm | FDA UDI | Class II | Active |
| Gluteal Implant, Round, Textured, SDM | Size: 10.0cm x 10.0cm x 2.5cm | FDA UDI | Class II | Active |
| Malar Implant | Style 5 / Size 3 | FDA UDI | Class II | Active |
| ContourFlex™ Gluteal Implant | CCB5 / Size 4 | FDA UDI | Class II | Active |
| Conform™ Extended Anatomical Chin | Size: Medium | EUDAMEDFDA UDI | Class II | Active |
| Combined Malar | Size 3 | FDA UDI | Class II | Active |
| Composite™ ePTFE-Coated Auricular Base Frame | Size 63, Right | FDA UDI | Class II | Active |
| Chin Implant | Style 1 / Size 3 / Fleshtone | FDA UDI | Class II | Active |
| Contoured Carving Block Style 8 | Size 5 | FDA UDI | Class II | Active |
| Powerflex™ Pectoral Implant, Aiache Style 4, SDM | Size: 1, Left Side | FDA UDI | Class II | Active |
| Silver Curvilinear Silicone Implant | Size: Small | FDA UDI | Class II | Active |
| 900-020 Dorsal Columella Syle 2 Sizer Set | 900-020 | FDA UDI | Class II | Active |
| Silicone Sizer Set for ePTFE Midfacial | ESMF-SIZ | FDA UDI | Class II | Active |
| Contoured Carving Block | CCB8 / Size 5 | FDA UDI | Class II | Active |
| Contoured Carving Block Sizer Style 9 | Size 2 | FDA UDI | Class II | Active |
| Contoured Carving Block Sizer Style 9 | Size 1 | FDA UDI | Class II | Active |
| Gelzone Wrap | 5 cm x 30 cm (2 in x12 in) | FDA UDI | Class I | Active |
| Rectangular Carving Block 2.0 | Size: 14.9cm x 7.7cm x 2.0cm | EUDAMEDFDA UDI | Class II | Active |
| 900-009 Mittleman Geniomandibular Groove Jowl Sizer Set | 900-009 | FDA UDI | Class II | Active |
| ContourFlex™ Gluteal Implant, Smooth (Round) | Size: 13.5cm x 13.5cm x 4.5cm | FDA UDI | Class II | Active |
| Temporal Shell Implant | Size: 9mm, Right | FDA UDI | Class II | Active |
| Chin Implant | Style 8 / Size 1 | FDA UDI | Class II | Active |
| ePTFE Nasal Dorsum, Round | Size: Small / 2.3mm | FDA UDI | Class II | Active |
| Powerflex™ Pectoral Implant | ACPI / Size 2 / Right | FDA UDI | Class II | Active |
| Rectangular Carving Block 1.3 | Size: 14.8cm x 7.6cm x 1.3cm | FDA UDI | Class II | Active |
| Cleft Chin | Size 2 | FDA UDI | Class II | Active |
| Rectangular Carving Block 1.3 | Size: 14.8cm x 7.6cm x 1.3cm | FDA UDI | Class II | Active |
| Dorsal Columella Style 5 | Size 2 | FDA UDI | Class II | Active |
| SG Pec Sizer | SGSIZ-RTS-PEC 42R | FDA UDI | Class II | Active |
| Composite Nasal Implant | ePTFE-VSDC-N4740 | FDA UDI | Class II | Active |
| Posterior Mandibular Angle™ | Size: 10, Right | EUDAMEDFDA UDI | Class II | Active |
| ContourFlex™ Gluteal Implant Sizer | Anatomical / Size 72 | FDA UDI | Class II | Active |
| Composite™ ePTFE-Coated Auricular Base Frame | Size 63, Left | FDA UDI | Class II | Active |
| Terino Square Chin-Style I | Size: Large | FDA UDI | Class II | Active |
| Vertical Mandibular Angle™ | Size: 11, Right | FDA UDI | Class II | Active |
| Voloshin Dorsal Columella | Size 2 | FDA UDI | Class II | Active |
| Contoured Carving Block Sizer | CCB4-3-SIZ | EUDAMEDFDA UDI | Class II | Active |
| ePTFE Sheet | Size: 10cm x 3cm x 4mm | FDA UDI | Class II | Active |
| Peri-Pyriform™ | Size: Medium | FDA UDI | Class II | Active |
| Composite™ ePTFE-Coated Auricular Anti-Helix | Size 63, Left | FDA UDI | Class II | Active |
| ePTFE Premaxillary | Size: Small | FDA UDI | Class II | Active |
| Nasal Implant | Style 12 / Size 7 | FDA UDI | Class II | Active |
| Terino Square Chin - Style II Sizers | TSCII-SIZ | EUDAMEDFDA UDI | Class II | Active |
| SLUP Nasal Implant | Size 7 | FDA UDI | Class II | Active |
| Chin Implant | Style 1 / Size 2 / Fleshtone | FDA UDI | Class II | Active |
| Shirakabe Nasal Implant, 3 Pack | Size: Large | FDA UDI | Class II | Active |
| Contoured Carving Block | CCB4 / Size 3 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Implantech Associates, Inc. has two FDA recall records, both initiated voluntarily in 2013 and 2014. The first, on August 30, 2013, involved certain lots of Terino Square Chin-Style II-Medicum devices that did not meet specified dimensional requirements. The second, on January 29, 2014, concerned a Gelzone Shoulder Sleever (Lot # 852766) where the Velcro closure may not have met customer robustness standards. Both recalls were subsequently terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 29, 2014 | Z-1063-2014 | — | terminated | 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. |
| Aug 30, 2013 | Z-2211-2013 | — | terminated | 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. |