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Various Branemark System Implants-Immediate Function Indication

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K022562

by Nobel Biocare AB

Identifiers

510(k) Number
K022562 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 Branemark System Implants - Immediate Function Indication are titanium dental implants designed for immediate loading and functional restoration in single-tooth or multiple-tooth applications. These implants rely on primary bone stability (Type I or II bone) and appropriate occlusal loading to support early chewing function, often splinted with a bar for multi-tooth cases.

Used in dental surgery, these implants are intended for immediate functional use following placement, adhering to protocols that ensure sufficient primary stability. Supplied sterile for single-use, they are classified under FDA Class II and comply with the Medical Device Directive (MDD). The device is authorised under 510(k) clearance (K022562) and is regulated as a dental implant system.

Frequently asked questions

What types of dental procedures are these implants designed for, and how quickly can patients expect to use them for chewing?

These Branemark System Implants with an Immediate Function Indication are specifically designed for single-tooth or multiple-tooth restorations where immediate loading is possible. Patients can begin functional chewing on the implants right after placement, provided the bone quality is Type I or II and the implant achieves primary stability. The implants are often splinted with a bar in multi-tooth cases to ensure stability during early loading.

Are these implants intended for reuse, or are they meant to be used only once?

These Branemark System Implants are supplied sterile and explicitly intended for single-use only. They are not designed for reuse, adhering to standard sterile medical device practices to ensure patient safety and infection control.

What regulatory pathways have been followed for this implant system, and which committee reviewed the submission?

The Branemark System Implants - Immediate Function Indication were cleared through the FDA’s 510(k) pathway under clearance number K022562, with a decision of Substantially Equivalent (SESE). The submission was reviewed by the Dental (DE) Advisory Committee, which categorizes dental implant systems under product code DZE.

How should these implants be stored, and what precautions should be taken before use?

Since these implants are sterile and single-use, they should be stored in their original packaging until ready for use. The packaging must remain unopened and intact to maintain sterility. Always follow the manufacturer’s instructions for handling and preparation to ensure proper sterility and functionality before implantation.

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: Various Branemark System Implants-immediate Function Indication, PDF Brånemark System®, NobelSpeedy® Groovy®, Twist Drills, Twist Step ..., Various Branemark System Implants-immediate Function Indication

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (2)

  • FDA 510(k) K022562 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026