Nobeldirect 3.0-IMMEDIATE Load, 3.0 × 13 mm and 3.0 × 15 mm
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070857 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nobeldirect 3.0-Immediate Load is a dental implant designed for immediate loading in the replacement of missing maxillary lateral incisors, mandibular central incisors, or mandibular lateral incisors. It is intended to support prosthetic devices, such as artificial teeth, to restore chewing function in partially edentulous patients. The implant features a 3.0 mm diameter with lengths of 13 mm and 15 mm, providing options for varying bone heights. Its design enables early functional loading under specific stability criteria.
This implant is supplied sterile and intended for single-use in dental procedures. It is classified under the FDA product code DZE (Dental Implants) and was granted 510(k) clearance (K070857) as substantially equivalent to a predicate device. Compatible components include impression copings, abutments, and scan bodies, all designed for integration with Nobel Biocare’s implant system. Storage requires adherence to sterile packaging instructions, and usage must comply with dental implant protocols to ensure proper osseointegration and immediate load stability.
Frequently asked questions
What dental sites is the Nobeldirect 3.0-Immediate Load implant designed for?
This implant is specifically engineered for replacing missing maxillary lateral incisors, mandibular central incisors, or mandibular lateral incisors. Its design prioritizes stability in these anterior regions to enable immediate loading of prosthetic devices, restoring chewing function while minimizing patient downtime.
How is the Nobeldirect 3.0-Immediate Load implant supplied and intended for use?
The implant is supplied sterile in its packaging, ensuring readiness for immediate clinical use. It is intended for single-use only in dental procedures, adhering to standard aseptic protocols to prevent cross-contamination. This aligns with Nobel Biocare’s commitment to patient safety and procedural integrity.
What lengths and diameters are available for the Nobeldirect 3.0-Immediate Load?
The implant features a consistent 3.0 mm diameter with two length options: 13 mm and 15 mm. These dimensions cater to varying bone heights in the targeted incisor sites, allowing clinicians to select the appropriate length for optimal osseointegration and immediate load stability.
Are there specific storage instructions for this implant?
Storage must follow the sterile packaging instructions provided by Nobel Biocare. The implant should remain unopened until use and protected from contamination. Proper storage ensures sterility and maintains the implant’s integrity for immediate loading procedures.
What compatibility does the Nobeldirect 3.0-Immediate Load have with other components?
The implant integrates seamlessly with Nobel Biocare’s broader system, including impression copings, abutments, and scan bodies. These compatible components are designed to work together, ensuring a cohesive workflow from placement to prosthetic restoration while adhering to immediate load protocols.
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: Nobeldirect 3.0-immediate Load, 3.0 X 13 Mm and 3.0 X 15 Mm (K070857 ..., Nobel Biocare NobelDirect 3.0 Dental Implant | SpotImplant, NobelActive® 3.0 Dental Implant | 3.0x13mm | Nobel Biocare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070857 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
Sources (1)
- FDA 510(k) K070857 24 fields · synced Oct 6, 2026