NobelActive 3.0 GoldAdapt Abutments
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112259 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 NobelActive 3.0 GoldAdapt Abutments are dental abutments designed to interface with the Nobel Biocare NobelActive 3.0 implant system. These components are fabricated from a gold alloy and serve as connectors between dental implants and prosthetic crowns, facilitating the restoration of single-tooth or multi-tooth dental structures in narrow-space applications, such as lateral or central incisors.
These abutments are supplied sterile and intended for single-use in clinical dental settings. They are classified under the FDA’s dental category (product code NHA) and comply with both FDA 510(k) clearance (K112259) and the EU’s Medical Device Directive (MDD). No MRI safety information is specified, and sizes or additional technical specifications beyond the alloy composition are not detailed in the regulatory submission.
Frequently asked questions
Are these abutments reusable in a clinical setting, or are they meant for single-use only?
The NobelActive 3.0 GoldAdapt Abutments are explicitly intended for single-use in clinical dental settings, as stated in the device description. This aligns with standard practices for dental implants to ensure sterility and patient safety, avoiding cross-contamination risks.
What types of dental restorations can these abutments support, and why are they particularly suited for narrow spaces?
These abutments connect dental implants to prosthetic crowns for restoring single-tooth or multi-tooth structures, with a focus on narrow-space applications like lateral or central incisors. Their design facilitates precise adaptation in confined areas, ensuring stability and proper alignment for restorative work.
How are these abutments supplied, and what does the sterility claim mean for clinical use?
The NobelActive 3.0 GoldAdapt Abutments are supplied sterile, meaning they undergo processing to eliminate microbial contamination before packaging. This ensures they can be safely used immediately upon opening in clinical settings without additional sterilization, reducing procedural risks.
What material are these abutments made from, and why is this relevant for patients?
These abutments are fabricated from a gold alloy, which is known for its biocompatibility, corrosion resistance, and durability. Gold alloys are commonly used in dental implants due to their ability to integrate well with surrounding tissues and minimize allergic reactions, making them a reliable choice for long-term restorations.
What regulatory pathways have these abutments followed, and how does that affect their availability?
The NobelActive 3.0 GoldAdapt Abutments have received FDA 510(k) clearance (K112259) under the dental category (product code NHA) and comply with the EU’s Medical Device Directive (MDD). This means they are legally authorized for sale in the U.S. and EU markets, though clinicians should verify local regulations for specific practice requirements.
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: K112259 - NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS | FDA 510(k), PDF 1.4 510(k) Summary of Safety and Effectiveness, NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS - fda.report, NobelActive® - Nobel Biocare, PDF K112259 - Nobelactive 3.0 Goldadapt Abutments
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112259 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
Sources (2)
- FDA 510(k) K112259 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026