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Teeth in an Hour - ARK Implant Concept

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030685

by Nobel Biocare AB

Identifiers

510(k) Number
K030685 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 Teeth in an Hour - ARK Implant Concept is a dental implant system designed for the placement of implant fixtures in totally edentulous jaws. It is classified as a dental implant device, enabling immediate loading of prosthetic teeth during a single surgical procedure. The system is intended to restore full functionality to patients with complete tooth loss, facilitating rapid and efficient rehabilitation. Its design supports the integration of fixtures within the jawbone to support dental prosthetics.

This implant system is supplied as a sterile, single-use device and is intended for use in clinical settings by trained oral surgeons and restorative dentists. The procedure is conducted under controlled conditions to ensure proper placement and immediate loading of the implant fixtures. The device is regulated under FDA 510(k) clearance (K030685) and is categorized under product code DZE. No additional regulatory status beyond the stated clearance is implied.

Frequently asked questions

What is the Teeth in an Hour ARK Implant Concept used for?

This system is designed specifically for patients with completely edentulous (toothless) jaws. It allows dental implant fixtures to be placed and immediately loaded with prosthetic teeth in a single surgical session, restoring full oral function quickly. The procedure is intended for use only by trained oral surgeons or restorative dentists in controlled clinical settings.

How is the Teeth in an Hour ARK Implant System supplied?

The device is supplied as a sterile, single-use implant system. This ensures each patient receives a clean, uncontaminated set of components tailored for one surgical procedure, reducing the risk of cross-contamination and maintaining hygiene standards in clinical environments.

Is this implant system reusable or intended for single use?

The system is explicitly designed for single-use only. This design choice aligns with clinical best practices for implant systems, minimizing infection risks and ensuring consistent performance. Reuse is not recommended or supported by the manufacturer.

What regulatory approval does the Teeth in an Hour ARK Implant Concept hold?

The device holds FDA 510(k) clearance under the reference number K030685, classified under product code DZE. This clearance confirms it is deemed substantially equivalent to a legally marketed predicate device for its intended use in restoring edentulous jaws with immediate loading implants.

Who should perform the procedure using this implant system?

The procedure should only be performed by trained oral surgeons or restorative dentists. The system’s design and immediate-loading capability require specialized clinical expertise to ensure proper fixture placement, bone integration, and prosthetic attachment for long-term success and patient safety.

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: TEETH IN AN HOUR - ARK IMPLANT CONCEPT - Innolitics, What is Teeth in an Hour? A Quick Guide to Same-Day Dental Implants, K030685 FDA 510 (k) - TEETH IN AN HOUR - ARK IMPLANT CONCEPT, Teeth-In-An-Hour™ - Love Your Jaws

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (1)

  • FDA 510(k) K030685 24 fields · synced Oct 5, 2026