Identifiers
- 510(k) Number
- K983754 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 Standard Chin is an internal chin prosthesis (FWP product code) designed for augmenting or reconstructing the anterior mandible. Classified as a Prosthesis, Chin, Internal under FDA nomenclature, it is intended for use in general plastic surgery procedures to restore or enhance facial contours.
This device is supplied as a single-use, sterile implant and is regulated under FDA 510(k) clearance (K983754) as a Class II device under Special Controls. It is intended for surgical use in a controlled clinical setting and must be implanted by a qualified healthcare professional. No additional regulatory status beyond the stated FDA clearance is implied.
Frequently asked questions
What is the Standard Chin implant used for in surgical procedures?
The Standard Chin implant is specifically designed for augmenting or reconstructing the anterior mandible, which is the front portion of the lower jaw. It is intended to restore or enhance facial contours in general plastic surgery procedures, helping patients achieve a more balanced or improved chin appearance.
Is the Standard Chin implant reusable or intended for single-use?
The Standard Chin implant is supplied as a single-use, sterile device. This means it is intended for one-time surgical use only and should not be reused after implantation, as reuse could compromise sterility and patient safety.
How is the Standard Chin implant regulated by the FDA?
The Standard Chin implant is regulated under the FDA’s 510(k) clearance process and is classified as a Class II device under Special Controls. It was granted clearance (K983754) in 1998 and is intended for use in controlled clinical settings by qualified healthcare professionals.
What types of sizes or models are available for the Standard Chin implant?
The provided data does not specify exact sizes or model variations for the Standard Chin implant. However, as an internal chin prosthesis, it is likely available in multiple sizes to accommodate different patient anatomies. For precise sizing options, consulting the manufacturer’s catalog or a surgical specialist is recommended.
How should the Standard Chin implant be stored before use?
Since the Standard Chin implant is supplied sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to maintain sterility.
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: K983754 FDA 510 (k) - STANDARD CHIN, FDA Browser - Cleared 510 (K) - STANDARD CHIN (K983754), Surgical Technology Laboratories, Inc. FDA 510 (k) Products (1980-2017), SURGICAL TECHNOLOGY LABORATORIES INC. - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983754 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgical Technology Laboratories Inc
- FDA Applicant
- Surgical Technology Laboratories, Inc.
Sources (1)
- FDA 510(k) K983754 24 fields · synced Sep 19, 2026