KERADEC is a fuse-on gold paste, which can be used by dental technicians to manufacture dental appliances for patients. It is intended for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surfaces and inlay imitations. In addition, it can be used within the AGC electroforming technique to manufacture AGC Bridges with the sintering procedure.

Device Description

KERADEC is a fuse-on gold paste, which can be used by dental technicians to fabricate dental appliances for patients. It consists of spherical gold particles and an organic liquid. KERADEC is intended for gold coating of white dental alloys. It can be used for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surface and inlay imitations. The use of KERADEC improves the color reproduction of ceramics on white porcelainfused-to-metal alloys. It optimizes the color of white dental alloys and reduces oxidation of these alloys. It does not improve the metal to ceramic bond. For applying, KERADEC has to be brushed onto the surface of the alloy and, after drying, it has to be fired in a ceramic furnace (820°C). In the course of these heat treatments, the organic liquid will completely vaporize and the gold will form a very thin layer of pure gold (99.99%), which is partly diffused into the surface of the alloy. KERADEC is highly corrosion resistant. It meats the essential requirements of the European directive 93/42/ECC concerning medical devices.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental product called KERADEC. This is a regulatory submission for a medical device and not a study proving device performance against acceptance criteria in the way you've outlined for an AI/algorithm-based device.

The information describes the device, its intended use, and its substantial equivalence to a predicate device. It confirms that the device is a gold-based alloy for clinical use in dentistry, specifically for gold coating white dental alloys and for use in AGC electroforming techniques.

Therefore, I cannot provide the information requested in your numbered list because the provided document does not contain a study or data demonstrating specific performance metrics, test sets, or ground truth establishment for an AI/algorithm.

The document discusses:

Device Description: KERADEC is a fuse-on gold paste consisting of spherical gold particles and an organic liquid.
Intended Use: Gold coating of white dental alloys, eliminating casting cavities, gold coating occlusal surfaces, inlay imitations, and use in AGC electroforming.
Regulatory Classification: Class II medical device (Product Code EJT, Regulation Number 872.3060).
Predicate Device: Blendgold Special (K 851872).
Safety/Performance claim: It is highly corrosion resistant and meets the essential requirements of the European directive 93/42/ECC concerning medical devices. However, this is a general statement about compliance, not specific performance metrics from a study.

There is no mention of acceptance criteria, a study proving performance, sample sizes, experts, ground truth, or AI-related metrics in this regulatory filing.

Summary

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KO22663

Premarket Notification 510(k)

KERADEC

15. 510 (k) Summary

'Submitter of 510(k):

Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0

Contact person:
Phone:
Fax:
e-mail:

Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 qerhard.polzer@wieland-dental.de

Date of Summarv:

Trade name:

KERADEC

2002-07-30

Classification name: Product code: C.D.R section: Classification:

Alloy, gold based, for clinical use EJT 872.3060 Class II

Legally marketed equivalent device: Blendgold Special 510(k) number: K 851872

Device description

KERADEC is a fuse-on gold paste, which can be used by dental technicians to fabricate dental appliances for patients. It consists of spherical gold particles and an organic liquid.

KERADEC is intended for gold coating of white dental alloys. It can be used for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surface and inlay imitations.

The use of KERADEC improves the color reproduction of ceramics on white porcelainfused-to-metal alloys. It optimizes the color of white dental alloys and reduces oxidation of these alloys. It does not improve the metal to ceramic bond.

For applying, KERADEC has to be brushed onto the surface of the alloy and, after drying, it has to be fired in a ceramic furnace (820°C). In the course of these heat treatments, the organic liquid will completely vaporize and the gold will form a very thin layer of pure gold (99.99%), which is partly diffused into the surface of the alloy.

KERADEC is highly corrosion resistant. It meats the essential requirements of the European directive 93/42/ECC concerning medical devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY

Re: K022663

Trade/Device Name: KERADEC Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: August 5. 2002 Received: August 9, 2002

OCT 3 1 2002

Dear Dr. Polzer:

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 vour 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.

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.

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Page 2 - Dr. Polzer

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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4513. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1
Page _ of _

510(k) Number (if known):

KERADEC Device Name:_

Indications For Use:

KERADEC is a fuse-on gold paste, which can be used by dental technicians to manufacture dental appliances for patients.

lt is intended for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surfaces and inlay imitations.

In addition, it can be used within the AGC electroforming technique to manufacture AGC Bridges with the sintering procedure. ·

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Suan Runn
--	-----------------------------------

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

510(k) Number:	K220663
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Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Formal 1-2-96)

Regulation Number and Section

§ 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.