K Number
K993572
Device Name
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
Manufacturer
Date Cleared
1999-12-13

(53 days)

Product Code
Regulation Number
872.3710
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium - Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth. - Classifcation: Class II C-
Device Description
Ceradium V Non-Precious Ceramic Alloy
More Information

Not Found

Not Found

No
The summary describes a dental alloy material and its intended use in fabricating dental devices, with no mention of AI or ML.

No
The device is a material (base metal alloy) used by a dentist to fabricate a custom-made dental device (porcelain veneer), which is then a therapeutic device. The alloy itself is not a therapeutic device.

No
The device is described as a base metal alloy used by a dentist for fabricating a custom-made dental device like a porcelain veneer, indicating it's a material for creation rather than diagnosis.

No

The device description clearly states it is a "base metal alloy" and a "material," indicating a physical substance, 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 the fabrication of a custom-made dental device (like a porcelain veneer) by a dentist. This is a material used in a medical device, not a device used to diagnose a condition by examining samples from the human body.
  • Device Description: The device is described as a "Non-Precious Ceramic Alloy," which is a material.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely as a material for creating a dental restoration.

N/A

Intended Use / Indications for Use

  • Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium
  • Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.

Product codes

EJH

Device Description

Not Found

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

Dentist

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble a caduceus or a stylized representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1999

Mr. Paul L. Saxton Manager Education and Technical Service Matech, Inc. 13010 San Fernando Rd. Sylmar, California 91342

K993572 Re: Ceradium V Non-Precious Ceramic Alloy Trade Name: Regulatory Class: II Product Code: EJH Dated: Undated Received: October 21, 1999

Dear Mr. Saxton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

1

Page 2 - Mr. Saxton

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdatgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timòthy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

K993572

Document #: g 055589

510 (k) Number (if known): K993572
Device Name: Ceradium V Non-Precious Ceramic Alloy
510 (k) Request Matech, Inc.

Indications For Use:

  • Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium
  • Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
  • Classifcation: Class II C-

Sincerely,

Paul E. Seton

1 L. Saxte anager Matech, Inc. 3010 San Fernando Rd. Sylmar, Ca 91342

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number KM3572

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)