Identifiers
- 510(k) Number
- K082299 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 Vericore Implant Abutments are classified as Dental Implant Abutments (Product Code: NHA) and serve as the connection between endosseous dental implants and prosthetic restorations. Constructed from yttria-stabilized zirconia for the abutment, titanium grade Ti-6Al-4V for the screw, and titanium grade 4 for the adaptor, these components ensure a secure, sealed interface for stability. Designed for dental professionals, they facilitate the attachment of prosthetic crowns or bridges to dental implants, restoring function and aesthetics in oral rehabilitation.
Used exclusively in clinical dental settings, Vericore Implant Abutments are single-use components intended for direct placement over dental implants. The titanium adaptor interfaces between the abutment and implant, ensuring a stable fit and preventing microleakage. Supplied sterile and packaged for one-time use, these abutments comply with FDA 510(k) clearance (K082299) under the Traditional review pathway. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
Are Vericore Implant Abutments reusable or designed for single-use only?
Vericore Implant Abutments are explicitly designed for single-use only. The packaging is sterile and intended for direct clinical placement over dental implants, ensuring patient safety and preventing cross-contamination. Reuse is not recommended or supported by the manufacturer.
What materials are used in the Vericore Implant Abutments, and how do they contribute to their function?
The abutment itself is made from yttria-stabilized zirconia, which provides a biocompatible, aesthetic surface for prosthetic attachments. The screw is constructed from titanium grade Ti-6Al-4V, offering strength and corrosion resistance, while the titanium grade 4 adaptor ensures a secure, sealed interface between the abutment and the dental implant. This combination minimizes microleakage and ensures long-term stability for prosthetic restorations.
How are Vericore Implant Abutments supplied, and what does the sterile packaging imply for clinical use?
Vericore Implant Abutments are supplied sterile and pre-packaged for one-time clinical use. The sterile packaging ensures they are ready for immediate placement in dental procedures without additional sterilization, reducing the risk of contamination. This aligns with their single-use design, as they are not intended for reprocessing or reuse.
What regulatory pathway was followed for the FDA clearance of Vericore Implant Abutments, and what does this mean for clinicians?
The Vericore Implant Abutments received FDA 510(k) clearance (K082299) under the Traditional review pathway, meaning the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device. For clinicians, this indicates that the device has undergone regulatory scrutiny to ensure safety and effectiveness for its intended use as a dental implant abutment, though it does not imply any additional clinical indications beyond what is described in the device labeling.
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: Whip-Mix Corp. · DeviceClearance, VERICORE IMPLANT ABUTMENTS (K082299) — FDA 510(k) | Innolitics, Vericore Abutment in Titanium for Implant Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082299 | Class II | Active |
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Manufacturer
- Manufacturer
- Whip Mix Corp.
- FDA Applicant
- Whip-Mix Corp.
Sources (1)
- FDA 510(k) K082299 24 fields · synced Sep 19, 2026