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K Number
K032319
Device Name
CERA R PLUS ALLOY
Manufacturer
DENTSPLY INTERNATIONAL
Date Cleared
2003-09-30

(64 days)

Product Code
EJT
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
K951780
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

Device Description

CERA R PLUS ALLOY is a gold-based dental alloy for prosthodontic devices.

AI/ML Overview

The provided text is a 510(k) summary for "CERA R PLUS ALLOY," a gold-based dental alloy. It explicitly states that no specific acceptance criteria or a study demonstrating the device meets such criteria are included in this document because the device relies on substantial equivalence to predicate devices and historical use.

The core argument for the device's safety and effectiveness is based on:

  • Similarity to legally marketed dental alloys: "CERA R PLUS ALLOY is very similar in formulation to legally marketed dental alloys."
  • Prior use of components: "All of the components found in CERA R PLUS ALLOY have been used in marketed devices."
  • Historical use in Europe: "This alloy has been on the European market since 1998 with over 800,000 units placed."

Based on these points, the document states: "Therefore, it was determined that no biocompatibility testing was necessary." This implies that without specific biocompatibility testing or performance studies, there wouldn't be set acceptance criteria for such tests.

Therefore, I cannot provide the requested table and study details because they are not present in the provided document. The document specifically points out that these types of studies were deemed unnecessary due to the device's nature and history.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.