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Dental Porcelain Powder

by Yilink (Tianjin) Biotechnology Co., Ltd

510(k) K242400Ref 17-06-02Model PAS、POW、LIQ

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242400↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697720971763NP Basic UDI-DI Date28 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK242400 Date10 Oct 2024ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
PAS、POW、LIQ, 17-06-02
FDA applicant
Yilink (Tianjin) Biotechnology Co., Ltd.
Primary DI / UDI-DI
06977209717647, 06977209717630
Basic UDI-DI
697720971763NP
510(k) Number
FDA Product Code
EIH
EMDN Code
Q01020601 Mobile dental prostheses
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 872.6660
EU market of registration
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Porcelain Powder for Clinical Use, classified under 21 CFR 872.6660 and designated as a Class II medical device. It is intended for use in dental applications, specifically as a material for dental restorations or prosthetics, where it is processed to form porcelain structures used in crowns, bridges, or inlays/onlays. The powder is designed to be mixed with a liquid to create a workable ceramic material for dental technicians.

The Dental Porcelain Powder is supplied as a single-use product, requiring preparation by dental professionals in a clinical setting. It is regulated under FDA 510(k) clearance (K242400) and MDR (Medical Device Regulation) compliance, with a Substantially Equivalent (SESE) determination. No specific sterility or MRI safety information is provided in the data, and the product is intended for use in controlled dental laboratories or clinics. Storage conditions are not detailed, but typical handling for dental ceramics applies.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dental Porcelain Powder from Yilink (Tianjin) Biotechnology Co., Ltd. used for in dental procedures?

    This product is specifically designed for dental restorations or prosthetics, serving as a material for creating porcelain structures used in crowns, bridges, or inlays/onlays. It is mixed with a liquid by dental professionals to form a workable ceramic material for fabrication in controlled dental laboratories or clinics.

  • Is the Dental Porcelain Powder single-use or reusable, and how should it be prepared?

    The Dental Porcelain Powder is intended for single-use only. It requires preparation by dental professionals in a clinical setting, where it is mixed with a liquid to form the ceramic material needed for dental restorations.

  • What regulatory pathways has this device followed, and what does the ‘SESE’ designation mean?

    The device has undergone FDA 510(k) clearance (K242400) and complies with the Medical Device Regulation (MDR). The ‘SESE’ (Substantially Equivalent to a legally marketed predicate) designation indicates that the device has been determined to be substantially equivalent to another already cleared product, ensuring it meets the same safety and performance standards.

  • Are there any specific storage instructions provided for the Dental Porcelain Powder?

    The provided data does not specify exact storage conditions, but it is typical for dental ceramics to be stored in a clean, dry environment, protected from moisture and extreme temperatures. Always follow standard handling practices for dental materials to maintain product integrity.

  • How is this product classified, and what classification category does it fall under?

    The Dental Porcelain Powder is classified under 21 CFR 872.6660 as a Class II medical device, which means it is subject to stricter regulatory controls than Class I devices but does not require the same level of scrutiny as Class III. This classification is based on its intended use in dental restorations.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No