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PANAVIA SA Cement Plus Automix - Automix Trial (Universal(A2), White, Translucent)

by Kuraray Noritake Dental Inc.

510(k) K142625

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) K142625↗

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
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142625 Date27 Jan 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
EMA
Models / Variants
Automix Trial (Universal(A2), White, Translucent)
FDA applicant
Kuraray Noritake Dental, Inc.
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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.

Panavia SA Cement Plus Automix is a dental resin cement classified under the nomenclature for Cement, Dental. It is designed for bonding dental restorations, including those made from zirconia, ceramics, and other substrates, using a self-mixing adhesive system. The formulation includes universal (A2) and translucent variants, ensuring compatibility with various tooth shades and restoration materials.

This device is supplied as a ready-to-use, single-use system, including mixing tips and endodontic tips (SS). It is intended for use in clinical dental settings and requires proper handling to maintain sterility. The Automix Trial and Value Pack variants are available for different procedural needs, and the product adheres to FDA 510(k) and MDR regulatory standards. Storage conditions must be followed to preserve performance, as specified in the manufacturer’s instructions.

Other devices from Kuraray Noritake Dental Inc.

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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 types of dental restorations can Panavia SA Cement Plus Automix be used to bond, and why is this important for clinicians?

    Panavia SA Cement Plus Automix is specifically designed for bonding dental restorations made from zirconia, ceramics, and other substrates. This versatility is important for clinicians because it ensures compatibility with a wide range of materials commonly used in modern dentistry, such as crowns, bridges, and inlays/onlays. The universal (A2) and translucent variants further allow for better shade matching, reducing the risk of visible gaps or discoloration at the restoration interface.

  • Is Panavia SA Cement Plus Automix intended for single-use only, and how does this affect clinical workflow?

    Yes, Panavia SA Cement Plus Automix is supplied as a ready-to-use, single-use system. This design ensures sterility and eliminates the need for additional preparation or mixing steps in the clinic, streamlining the workflow. Clinicians can rely on consistent performance without cross-contamination concerns, as each kit is pre-mixed and ready for immediate use.

  • What color options are available for Panavia SA Cement Plus Automix, and how do they benefit the clinician?

    Panavia SA Cement Plus Automix comes in universal (A2) and translucent variants. The universal shade (A2) provides a balanced match for most tooth colors, while the translucent option allows for better integration with lighter or more translucent restorations. This flexibility helps clinicians achieve more natural-looking results, reducing the need for additional adjustments or corrections.

  • Are there different packaging options for Panavia SA Cement Plus Automix, and how might a clinician choose between them?

    Yes, the product is available in three packaging variants: the Panavia SA Cement Plus Automix (standard), the Value Pack (translucent variant), and the Automix Trial (universal or white/translucent). Clinicians may choose the Automix Trial for testing the product’s performance before committing to larger quantities, while the Value Pack offers a cost-effective option for bulk translucent cement needs. The standard version provides flexibility for general use with both universal and translucent applications.

  • What regulatory standards does Panavia SA Cement Plus Automix comply with, and how does this impact its use in clinical settings?

    Panavia SA Cement Plus Automix has been authorized under FDA 510(k) and MDR (Medical Device Regulation) standards, indicating it meets stringent safety and performance requirements. This compliance ensures that clinicians can confidently use the product in clinical settings, knowing it adheres to global regulatory expectations for dental cements. The product’s classification under FDA Device Class II further confirms its role as a well-vetted, reliable option for bonding dental restorations.