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Fill-Up!

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150218

by Coltène/Whaledent AG

Identifiers

510(k) Number
K150218 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fill-Up! is a dental filling material designed for use in restorative procedures. Classified under product code EBF, it is intended for filling cavities and restoring tooth structure, providing durable and biocompatible dental restoration.

This device is supplied as a single-use material and is intended for use in dental offices. It is not sterile at the time of shipment but is packaged in a manner that allows for easy sterilization prior to use. The device is regulated under the FDA’s 510(k) clearance process, with a clearance number of K150218, and is manufactured by Coltène/Whaledent AG in Altstätten, Switzerland.

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: Fill-Up! Brochure (31275B)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coltène/Whaledent AG
FDA Applicant
Coltene/Whaledent AG

Sources (1)

  • FDA 510(k) K150218 24 fields · synced Oct 1, 2026