(90 days)
K 880875
K 880875
No
The summary describes a base metal casting alloy for dental frameworks, with no mention of AI, ML, image processing, or any software-driven functionality.
No.
The device is a casting alloy used to produce partial denture frameworks, which are prosthetic devices used to replace missing teeth, not therapeutic in nature.
No
The device is described as a base metal casting alloy for producing removable partial denture frameworks, which is a restorative function, not a diagnostic one.
No
The device is described as "base metal casting alloys" and "cobalt chrome casting alloys," which are physical materials used for casting, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "casting removable partial denture frameworks." This is a manufacturing process for a dental prosthetic, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The device is described as "base metal casting alloys." This refers to the material used to create the denture framework, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a material used in the creation of a medical device (a partial denture framework), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks.
Product codes
Not Found
Device Description
The family of Base Metal Casting Alloys are cobalt chrome casting alloys substantially equivalent to the alloys currently used to produce partial denture frameworks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 880875
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.
0
4101 W. 51ST STREET
CHICAGO, IL 60632-4287
TEL 312.735.0600
800.621.0381
FAX 312.735.3940
AUSTENAL
510 (K) Notification Summary
Attachment # 1
Pre-market Notification: K970205
Submitter's Name: Austenal, Inc.
4101 W. 51st Street
Chicago, IL.
Telephone: 773-735-0600
Fax: 773-735-3940
Contact Person: Ronald Dudek
Date of Filing: March 31, 1997
Trade Names of Alloy:
-
Vitallium 2000 Alloy
-
Vitallium 2000 Plus Alloy
Signature:
Ronald Dudek -
Cobalt Chrome Casting Alloy
The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks. These products are part of a class of materials called base metal casting alloys. Substantially, equivalent products for these products are preammendment devices Vitallium Alloy, Vitallium 2 Alloy, and Vitallium Equipoise Alloy cover by 510 (K) Notification K 880875.
Vitallium 2000 Alloy, Vitallium 2000 Plus Alloy, Cobalt Chrome Casting Alloy, and the predicate products comply with the compositional and mechanical property requirements of ISO Product Standard: ISO 6871, Base Metal Casting Alloys- Part I Cobalt Based Alloys and ANSI/ADA Standard Specification ANSI/ADA # 14 Base Metal Casting Alloys.
Composition Requirements
| Cobalt + Chromium + Molybdenum | ≥ | 85% |
|---|---|---|
| Vitallium Alloy | 98.1% | |
| Vitallium 2 Alloy | 98.0% | |
| Vitallium Equipoise Alloy | 98.1 % | |
| Vitallium 2000 Alloy | 98.3% | |
| Vitallium 2000 Plus Alloy | 98.0% | |
| Cobalt Chrome Casting Alloy | 97.5% |
Mechanical Property Requirements
| ISO/ANSI/ADA Requirement | 0.2%
Yield Strength | %
Elongation |
|-----------------------------|------------------------|-----------------|
| | $\ge$ 500 MPa | $\ge$ 3% |
| Vitallium Alloy | 616 | 4.5 |
| Vitallium 2 Alloy | 551 | 9.6 |
| Vitallium Equipoise Alloy | 585 | 3.0 |
| Vitallium 2000 Alloy | 609 | 8.9 |
| Vitallium 2000 Plus Alloy | 690 | 19.5 |
| Cobalt Chrome Casting Alloy | 555 | 6.0 |
Instructions and labels for these products also complies with the ISO and ANSI/ADA standards guidelines.
1
AUSTENAL
4101 W. 51ST STREET
CHICAGO, IL 60632-4287
TEL 312.735.0600
800.621.0381
FAX 312.735.3940
Base Metal Casting Alloys 510(k) Notification Summary
The family of Base Metal Casting Alloys are cobalt chrome casting alloys substantially equivalent to the alloys currently used to produce partial denture frameworks.
Alloys of this type are used extensively in the fabrication of partial dentures and have histories of excellent clinical performance and also complies with ANSI/American Dental Association Specification No. 14 for Base Metal Alloys and ISO 6871 Part 1 for Base Metal Casting Alloys- Cobalt Based.