Identifiers
- 510(k) Number
- K201197 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TruAbutment DS, TruBase S is a patient-specific dental abutment system designed for use with endosseous dental implants. These components are engineered to interface directly with implant fixtures, facilitating the attachment of zirconia or other CAD/CAM-based restorative frameworks. The system includes custom-milled abutments tailored to individual patient anatomy, ensuring precise fit and stability for prosthetic restoration.
The TruAbutment DS, TruBase S is supplied as a reusable, non-sterile component intended for milling at the manufacturer’s facility. It is manufactured in a dedicated milling center and requires CAD/CAM technology for customization based on patient-specific digital scans. The product is classified under FDA product code NHA (Dental Abutments) and holds a Traditional 510(k) clearance for dental use. No additional sterility or single-use claims are specified.
Frequently asked questions
What types of dental restorations can the TruAbutment DS, TruBase S system be used with, and how does it ensure a precise fit for the patient?
The TruAbutment DS, TruBase S system is designed to interface with endosseous dental implants and supports the attachment of zirconia or other CAD/CAM-based restorative frameworks. The custom-milled abutments are tailored to individual patient anatomy using digital scans and CAD/CAM technology, ensuring a precise and stable fit for prosthetic restoration.
Is the TruAbutment DS, TruBase S system intended for single-use or can it be reused? How does this affect its handling and sterilization?
The TruAbutment DS, TruBase S is explicitly described as a reusable component, not single-use. Since it is non-sterile as supplied, it must be milled at the manufacturer’s facility before use. Sterilization is not required for the base component itself, but proper handling and cleaning protocols should be followed if reused in a clinical setting, as no additional sterility claims are specified.
How is the TruAbutment DS, TruBase S system ordered or supplied, and what steps are required before clinical use?
The system is supplied as a non-sterile, reusable component intended for milling at the manufacturer’s dedicated facility. Before clinical use, patient-specific digital scans must be provided to enable custom milling via CAD/CAM technology, ensuring the abutments are tailored to the individual patient’s anatomy.
What regulatory pathway does the TruAbutment DS, TruBase S follow, and what does this mean for its use in dental practices?
The TruAbutment DS, TruBase S holds a Traditional 510(k) clearance from the FDA under product code NHA (Dental Abutments). This means it has been deemed substantially equivalent to a legally marketed predicate device and is approved for dental use as described—specifically for interfacing with endosseous implants to support restorative frameworks. No additional regulatory claims beyond this are specified.
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: TruBase - TruAbutment Inc., TruBase - TruAbutment Inc., PDF 17666 Fitch Re: K241485 Trade/Device Name: TruAbutment DS; TruBase ..., TruAbutment DS; TruBase (K241485) — 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 | K201197 | Class II | Active |
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Manufacturer
- Manufacturer
- TruAbutment Inc.
- FDA Applicant
- Truabutment, Inc.
Sources (1)
- FDA 510(k) K201197 24 fields · synced Sep 19, 2026