Duralastic Anatomical Chin Implants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K973575 FDA 510(k)
- FDA Product Code
- FWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3550 FDA 510(k)
- Regulation Number
- 878.3550 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Duralastic Anatomical Chin Implants are internal chin prostheses designed for chin augmentation. These crescent-shaped, concave-convex silicone elastomer implants provide forward and lateral projection to enhance facial contours, with variations in size and style to accommodate different anatomical needs, including jowl augmentation.
These implants are supplied sterile and intended for single-use in surgical settings. They are classified as Class II devices under FDA regulations (878.3550) and have received 510(k) clearance (K973575) for use in general plastic surgery procedures. Multiple reference codes (e.g., 1032347, 3002821504) identify distinct sizes and styles, including flat-backed designs for increased projection in larger sizes.
Frequently asked questions
What types of facial contour enhancements can the Duralastic Anatomical Chin Implants address, and how do the different sizes and styles vary in their effects?
The Duralastic Anatomical Chin Implants are designed specifically for chin augmentation and jowl augmentation, providing both forward projection and lateral enhancement to refine facial contours. The crescent-shaped, concave-convex silicone elastomer implants come in multiple sizes and styles, including flat-backed designs for increased projection in larger sizes. This variety allows surgeons to select the appropriate implant to address individual anatomical needs, ensuring tailored results for patients.
Are these implants intended for reuse, or are they meant to be used only once during surgery?
The Duralastic Anatomical Chin Implants are explicitly supplied sterile and intended for single-use in surgical settings. This design ensures patient safety and reduces the risk of infection or contamination, aligning with best practices for implantable medical devices.
How are these implants classified under FDA regulations, and what does that mean for their use in clinical settings?
These implants are classified as Class II devices under FDA regulations (878.3550), which means they undergo a 510(k) clearance process to demonstrate substantial equivalence to a predicate device. This classification ensures they meet specific performance and safety standards before being authorized for use in general plastic surgery procedures, providing clinicians and patients with confidence in their reliability and efficacy.
What should clinicians consider when selecting a specific size or model of the Duralastic Anatomical Chin Implants for a patient?
Clinicians should consider the patient’s anatomical needs, including the degree of chin projection required and whether jowl augmentation is part of the procedure. The implants come in multiple sizes and styles, including flat-backed designs for greater projection in larger sizes, allowing for customization. The provided reference codes (e.g., 1032347, 3002821504) correspond to distinct sizes and styles, so selecting the appropriate code ensures the right implant is chosen for the intended outcome.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Chin Implants - Hanson Medical Inc. - Medical & Health Care Product ..., chin_implants - Hanson Medical Inc. - Medical & Health Care Product ..., K973575 FDA 510 (k) - DURALASTIC ANATOMICAL CHIN IMPLANTS, DURALASTIC ANATOMICAL CHIN IMPLANTS (K973575) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973575 | Class II | Active |
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Manufacturer
- Manufacturer
- Hanson Medical, Inc.
Sources (1)
- FDA 510(k) K973575 24 fields · synced Oct 6, 2026