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K Number
K981244
Device Name
BW-1 (CODE NAME RD-0807)
Manufacturer
J.F. JELENKO & CO., INC.
Date Cleared
1998-08-13

(129 days)

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

BW-1 ( Code Name : RD-0807 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. It can also be used as Type-III crown and bridge alloy. BW-1 is copper and palladium free, rich yellow color alloy and it provides quality restoration. It polishes to a high luster and is suitable for Single and 3 to 4 crowns.

Device Description

BW-1 (Code Name: RD-0807) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. It can also be used as Type-III crown and bridge alloy. BW-1 is copper and palladium free, rich yellow color alloy and it provides quality restoration. It polishes to a high luster and is suitable for Single and 3 to 4 crowns.

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy device (BW-1). This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its FDA clearance. However, it does not provide details on:

  1. Acceptance criteria table or reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used.
  8. Sample size or ground truth establishment for training sets.

The document is purely an administrative clearance letter and lacks the technical study details you are requesting.

§ 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.