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

(64 days)

Product Code
Regulation Number
872.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
More Information

No
The summary describes a dental alloy, a material, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

No
The device is a material (gold-based dental alloy) used for fabricating dental prosthetics, which are restorative devices, not therapeutic devices. Therapeutic devices are typically those that treat or cure a disease or condition.

No
Explanation: The device is a gold-based dental alloy used for fabricating prosthodontic devices, which are restorative rather than diagnostic. The "Intended Use / Indications for Use" section focuses on fabrication of dental prosthetics.

No

The device description clearly states it is a "gold-based dental alloy," which is a physical material, 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 fabricating dental prosthodontic devices (inlays, crowns, bridges, etc.). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The device is a dental alloy, a material used to create the prosthetics.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This dental alloy does not fit that description.

N/A

Intended Use / Indications for Use

CERA R PLUS ALLOY is indicated as a dental alloy for fabricating inlays. crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

Product codes

EJT

Device Description

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

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)

K951780

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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Image /page/0/Picture/0 description: The image shows a black and white abstract shape. The shape is roughly triangular, with the top right corner being the most defined point. The rest of the shape is filled with a grainy texture, giving it a rough and uneven appearance.

510(k) SUMMARY

KQ32319

NAME & ADDRESS:

DENTSPLY International

SEP 3 0 2003

570 West College Avenue O. Box 872 York, PA 17405-0872 717) 845-7511 17 17 1 2 2 2 2 2 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 ww.dentsplv.com

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

July 25, 2003 DATE PREPARED:

TRADE OR PROPRIETARY NAME: CERA R PLUS ALLOY

CLASSIFICATION NAME: Gold based alloy for clinical use (872.3060)

PREDICATE DEVICES: Stabilor NF IV alloy K951780

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

INTENDED USE: CERA R PLUS ALLOY is indicated as a dental alloy for fabricating inlays. crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in CERA R PLUS ALLOY have been used in marketed devices.

CERA R PLUS ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1998 with over 800,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary.

We believe that the prior use of the components of CERA R PLUS ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of CERA R PLUS ALLOY for the indicated uses.

1

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2003

Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K032319

Trade/Device Name: Cera R Plus Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003

Dear Mr. Lehn

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

2

Page 2 - Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known):

Device Name:

CERA R PLUS ALLOY

Indications for Use:

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

thell & the for MSR

hesiology, General Hospital, ontrol Der 510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)