Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.

Device Description

Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades: A1. A2, A3, A3.5, B1, B3, Bleach white. Kingscross temporary restorations can also be adjusted and customized using lightcuring composites. The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun. By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.

AI/ML Overview

The provided 510(k) summary for K122039, Kingscross Temporary Crown and Bridge Material, does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML or diagnostic device.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of material properties and intended use. The "acceptance criteria" here are implied by the performance of the predicate devices and the relevant industry standards for dental materials.

Here's an analysis based on the provided text, addressing the requested information to the best of its ability given the type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a dental material, the "acceptance criteria" are not quantitative thresholds set for a specific study, but rather that the material's properties are comparable to established predicate devices and meet relevant industry standards.

Acceptance Criteria (Implied by Predicate Devices & Standards)	Reported Device Performance (Kingscross)
Biocompatibility:	"Kingscross materials' biocompatibility data is comparable to other materials on the market." (ISO 10993 family tests: cytotoxicity, mutagenicity, sensitization, mucosa irritation, chemical analysis)
Mechanical Properties (Comparable to Predicate Devices & Industry Standards):	"The results indicate adequate strength results compared to leading temporary crown and bridge materials." "A comparison of the mechanical properties has also been performed in respect to the parameters and standards referenced under 'Summary of Non-Clinical Performance Testing'. The results also demonstrate substantial equivalence to the predicate devices." (Specific tests include: E-Modulus, Flexible strength, Impact strength, Compressive strength, Diametral tensile strength, Volume shrinkage, Max. temperature on cure, Inhibition layer, Extrusion force, as measured by ADA/ANSI and ISO standards).
Intended Use: For fabrication of temporary prostheses (crowns, bridges, inlays, onlays, etc.).	"Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated." (This matches the intended use of predicate devices, with some slight expansion for "customization" and "long-term temporary restorations" but argued as "no significant difference in intended use or technology").
Technology/Application: 2-paste system, dispensing gun, cartridge, mixing tip.	Matches predicate devices.

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing of material properties (E-Modulus, flexible strength, etc.) and biocompatibility tests.
Sample sizes for these material tests are not specified. For example, it doesn't state how many samples were tested for compressive strength or E-Modulus for Kingscross or the predicate devices.
Data provenance is not explicitly stated, but given the manufacturer is Kettenbach GmbH & Co KG in Germany, it's highly likely these tests were performed in Germany or by contract labs following international standards. These would be prospective tests performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the traditional sense for this device. This is a material claim, not a diagnostic or AI device that requires expert ground truth labeling of images or clinical cases. The "ground truth" here is adherence to established material testing standards (e.g., ADA/ANSI Specification No. 53, ISO 9917-1, OECD 487 for biocompatibility). The experts would be the chemists and material scientists performing and interpreting these standardized tests, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no expert adjudication process described for the quantitative material property tests. The results are objective measurements from standardized tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device or a diagnostic device involving human readers. Therefore, an MRMC study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental material, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established industry standards and the measured physical and chemical properties of the material itself, as well as the performance characteristics of the legally marketed predicate devices. No pathology, outcomes data, or expert consensus (in the clinical diagnosis sense) was used to establish ground truth for this type of submission.

8. The sample size for the training set

Not applicable. This device is a material, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

Summary

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K122039

DEC 2 7 2012

510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, Kettenbach GmbH & Co KG herewith submits a Summary of Safety and Effectiveness.

Name and address of manufacturer:

Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Establishment Registration No .: 9681356 Owner/Operator Number: 9022134

Name, title and phone number of official correspondent: Simon, Katia Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail:katja.simon@kettenbach.de

Name, title and phone number of U.S. Agent (Contact):

Roggenbau. Wilfried InterGest North America LLC. 400 Oser Ave., Suite 1650 Hauppauge, NY 11788 Phone: 631 5010500 ext Fax: 631 5011060 E-mail: roggenbauw@intergestna.com

Date of preparation:

November 23, 2012

Device Identification:

Device Trade Name: Versions: Common Name:

Kinascross B; PL-C+B-08; PL-C+B-10, PL-C+B-12 Temporary crown and bridge resin

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Classification of the device:

Device Classification Name: Product Code: Device Classification No .: Panel: Regulatory Status:

Crown And Bridge, Temporary, Resin EBG Part 872.3770 Dental Class II

Device Description:

A1. A2, A3, A3.5, B1, B3, Bleach white.

Kingscross temporary restorations can also be adjusted and customized using lightcuring composites.

The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun.

By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.

Intended Use:

Predicate devices:
Device Trade Name:	Integrity
Applicant:	Dentsply Intl.
510(k) No.:	K853052
Device Trade Name:	Luxatemp Ultra/Star
Applicant:	DMG USA, Inc.
510(k) No.:	K101710
Device Trade Name:	Luxatemp Automix
Applicant:	DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
510(k) No.:	K924830
Device Trade Name:	Protemp Plus
Applicant:	3M Espe
510(k) No.:	K073296

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	Substantial EquivalentDevicesKingscross			Predicate Devices
	B	PL-C+B-12	PL-C+B-10	PL-C+B-08	DentsplyIntegrity	DMGLuxatempStar	DMGLuxatempAutomix	3M EspeProtemp Plus
IntendedUse	Kingscross temporary crownand bridge material is intendedto be used for fabricationtemporary prostheses, such ascrowns, partial crowns, bridges,inlays, onlays and veneers, andfor customization ofprefabricated acrylic and metalcrowns and for fabrication oflong-term temporaryrestorations until a permanentrestoration is fabricated.				For the fabrication of temporary crowns and bridges until thepermanent restoration can be delivered.
ApplicationMixing	2-paste-system (catalyst/base)				Same	Same	Same	Same
	Dispensing gun, cartridge,mixing tip				Same	Same	Same	Same

predicate devices. A comparison of the mechanical properties has also been performed in respect to the parameters and standards referenced under "Summary of Non-Clinical Performance Testing".

The results also demonstrate substantial equivalence to the predicate devices.

The Kingscross temporary crown and bridges materials are considered substantially equivalent to the Protemp Plus (K073296), Dentsply Integrity (K853052), Luxatemp Ultra/Star (K101710) and Luxatemp Automix (K924830).

There is no significant difference in intended use or technology. Each version of the Kingscross material is substantially equivalent to the above listed predicate devices.

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Summary of Non-Clinical Performance Testing:

Biocompatiblity tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization and mucosa irritation (ISO 10993-10) and a chemical analysis showed, that Kingscross materials' biocompatibility data is comparable to other materials on the market.

Additionally bench testing was performed to allow an evaluation of the mechanical properties of Kingscross in comparison to already marketed products. The evaluation covers

E-Modulus (ADA/ANSI Specification No. 53, subclause 7.6) .
Flexible strength (ADA/ANSI Specification No. 53, subclause 7.6)
Impact strength
Compressive strength (ISO 9917-1, Annex D) .
Diametral tensile strength (ADA/ANSI Specification No. 27:1976) .
Volume shrinkage (DIN 13907) .
Max. temperature on cure
Inhibition layer .
. Extrusion force

The results indicate adequate strength results compared to leading temporary crown and bridge materials.

Conclusion:

Kettenbach GmbH & Co KG believes that the Kingscross temporary crown and bridge material is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is positioned to the right of a circular seal that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 27, 2012

Mr. Juergen Berger Regulatory Affairs Manager Kettenbach GmbH & Company KG Im Heerfeld 7 Eschenburg, Hessen Germany 35713

Re: K122039

Trade/Device Name: Kingscross Temporary Crown and Bridge Material Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 12, 2012 Received: December 26, 2012

Dear Mr. Berger:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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 that I Drederal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl it Fart 607); adoling (21 OFF 1 CFR 803); good manufacturing practice requirements as set de rico-related davers overily)S) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you acsille opeofics and AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part now the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame Q. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number (if known): K122039

Device Name:

Kingscross temporary crown and bridge material

Indications for Use:

mated on 1000.
Kingscross temporary crown and bridge material is intended to be used for fabrication of rangoroo tomperary crowns, partial crowns, bridges, inlays, onlays and veneers, and tor customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S Sheeria A. Green -3
2012.12.27 11:28:05 -05'00' For Susan Runner, DDS

(Division Sign-Off) (Division Sign-On)
Division of Anesthealology, General Hospital Division of Antol, Dental Devices

K122039 510(k) Number;

Page 1 of 1

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.