BRIGHTGLASS Discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined with the CAD/CAM technique. BRIGHTGLASS Discs are recommended for manufacturing substructures of single tooth crowns and bridgework with up to two pontics.

Device Description

BRIGHTGLASS discs are milling blanks composed of hot cured polymethymethacrylate (PMMA). They are intended to be used by dental professionals e.g. dental technicians for the fabrication of long-term temporary crowns and bridgeworks as custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations can thereafter be machined in all appropriate CAM Milling Centers out of BRIGHTGLASS Discs. In a further step the milled workpiece can be individually characterized with veneering materials and polished for to improve the aesthetic appearance of the finished restoration. BRIGHTGLASS discs are offered as monochromic disc (BRIGHT-GLASS) in six different shades and as multicolored disc (BRIGHT-GLASS M) in up to four shades, all discs in different thicknesses.

AI/ML Overview

The medical device described, BRIGHTGLASS and BRIGHTGLASS M, is a Temporary Crown and Bridge Resin (PMMA). The submission is a Traditional 510(k) by KTK Medical Supplies GmbH.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define discrete "acceptance criteria" with numerical thresholds for each test, nor does it present the "reported device performance" in a structured table or quantitative manner for each criterion. Instead, it describes a comparative testing approach.

The closest equivalent to acceptance criteria is implied through the stated goal of demonstrating "compatibility" and "substantially equivalent" to the predicate device (ZENO PMMA Discs) in a series of tests. Therefore, the "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the specified tests. The "reported device performance" is described qualitatively as being "comparable."

Test Performed	Implied Acceptance Criteria (Goal)	Reported Device Performance (Qualitative)
Tensile Strength	Comparable to ZENO PMMA Discs	Comparable to the predicate device
Elastic Limit	Comparable to ZENO PMMA Discs	Comparable to the predicate device
Bending Strength	Comparable to ZENO PMMA Discs	Comparable to the predicate device (noted as "major bending strength" and "extreme high homogeneity")
E-Module	Comparable to ZENO PMMA Discs	Comparable to the predicate device
Water Solubility	Comparable to ZENO PMMA Discs	Comparable to the predicate device
Water Absorption	Comparable to ZENO PMMA Discs	Comparable to the predicate device
Homogeneity	Comparable to ZENO PMMA Discs	"extreme high homogeneity"
Surface Density	Comparable to ZENO PMMA Discs	"high surface density"
Breaking Resistance	Comparable to ZENO PMMA Discs	"major breaking resistance"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size used for the mechanical and physical tests performed (tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption). It only states "a series of testing was performed."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's location (Germany) and the nature of physical/mechanical testing, it's highly probable the testing was conducted in a laboratory setting, likely in Germany, to generate prospective data. However, this is an inference.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This medical device is a material (PMMA) for dental fabrication, not an imaging or diagnostic device requiring expert interpretation of results for ground truth establishment in the traditional sense. The "ground truth" for the performance tests (tensile strength, etc.) is established through standardized physical and chemical measurement techniques and instruments, not human experts. There is no mention of experts establishing a "ground truth" for these measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for these material property tests is derived from standardized physical and chemical measurements, not from expert review or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret patient cases, comparing performance with and without AI assistance. The BRIGHTGLASS device is a dental material, not a diagnostic tool, so an MRMC study is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study in the context of an algorithm's performance was not done. This device is a material, not software or an algorithm. The "standalone" performance relates to the material's inherent physical and chemical properties as measured in a lab, which is what the comparative testing aimed to assess against the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption) is established through objective, quantifiable physical and chemical measurements obtained using standard laboratory methods and equipment, not expert consensus, pathology, or outcomes data. The "truth" is the measured value for each material property.

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured material, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Submitter: KTK Medical Supplies GmbH

Premarket Notification: Traditional 510(k) Temporary Crown and Bridge Resin (PMMA)

OCT
9
2012

510[k] Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Submitter Name	KTK Medical Supplies GmbH
Submitter AddressPhone NumberFax NumberContact Person	Industriestr. 16, 82110 Germering, Germany+49-89-8407970+49-89-84058896Thomas Lottermoser
Date summary was preparedDevice Trade Name(s)	2012-06-25BRIGHTGLASSBRIGHTGLASS M
Classification NameC.D.R. section numberProduct CodeRegulatory ClassPredicate Devices	Temporary Crown and Bridge Resin872.3770EBGclass IIK080182ZENO PMMA Discs
Device Description	BRIGHTGLASS discs are milling blanks composed of hot curedpolymethymethacrylate (PMMA).They are intended to be used by dental professionals e.g. dentaltechnicians for the fabrication of long-term temporary crowns andbridgeworks as custom-made restorations for the sole use of a par-ticular patient.These restorations are designed virtually by dental technicians us-ing the CAD technology on the basis of intraoral scans or scansfrom impressions and/or models.The designed restorations can thereafter be machined in all appro-priate CAM Milling Centers out of BRIGHTGLASS Discs.In a further step the milled workpiece can be individually character-ized with veneering materials and polished for to improve the aes-thetic appearance of the finished restoration.

page 5 – 2

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・

Submitter:	KTK Medical Supplies GmbH
	Premarket Notification: Traditional 510(k)
	Temporary Crown and Bridge Resin (PMMA)
	BRIGHTGLASS discs are offered as monochromic disc (BRIGHT-GLASS) in six different shades and as multicolored disc (BRIGHT-GLASS M) in up to four shades, all discs in different thicknesses.
Indications for Use	BRIGHTGLASS Discs are milling blanks consisting of polymethyl-methacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework using the CAD/CAM technique.
	BRIGHTGLASS Discs are recommended for manufacturing sub-structures of single tooth crowns and bridgework with up to two pontics.
Summary of technological characteristics / Testing Summary
	In order to demonstrate compatibility of BRIGHTGLASS PMMA discs to the predicate devices ZENO PMMA discs a series of testing was performed – in particular tensile strength, elastic limit, bending strength, e-module, water solubility and water absorption. See section 18.
Substantially Equivalence	The information discussed above demonstrates that BRIGHT-GLASS PMMA discs are substantially equivalent to the predicate dental device ZENO PMMA Discs.
	Both devices are polymethylmethacrylates (PMMA).
	Both devices have identical indications for use.
	Both devices have comparable technical, physical, chemical, and biological properties and characteristics.
	Both devices have the same aesthetic, prophylactic and diagnostic function.
	The thermoplastic manufactured BRIGHTGLASS disks shows like the predicate device an extreme high homogeneity and by the high surface density a major bending strength and breaking resistance.
	BRIGHTGLASS discs are as safe, as effective and performs as well than the predicate device.
Conclusion	The information discussed above demonstrates that the BRIGHT-GLASS discs are substantially equivalent to the predicate devices.
Declaration	This summary includes only information that is also covered in the body of the 510(k).
	This summary does not contain any puffery or unsubstantiated labeling claims.
	This summary does not contain any raw data, i.e., contains only summary data.

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Submitter: KTK Medical Supplies GmbH

Premarket Notification: Traditional 510(k) Temporary Crown and Bridge Resin (PMMA)

This summary does not contain any trade secret or confidential commercial information

This summary does not contain any patient identification information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.

OCT

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

2019

KTK Medical Supplies GmbH Mr. Thomas Lottermoser Chief Executive Officer Industriestr. 16 82110 Germering, Germany

Re: K122025

Trade/Device Name: Brightglass, Brightglass M Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: September 6, 2012 Received: September 6, 2012

Dear Mr. Lottermoser:

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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Page 2- Mr. Lottermoser

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/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 807.97). For questions 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

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

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Indications for Use

510(k) Number (if known):

K10026

Device Name:

BRIGHTGLASS

Indications For Use:

BRIGHTGLASS Discs are recommended for manufacturing substructures of single tooth crowns and bridgework with up to two pontics.

Suon Ruone

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of City

510(k) Number;

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)

KTK Medical Supplies GmbH Industriestr. 16 82110 Germering

Tel.: 089-840797-0 Fax: 089-84058896 info@ktkgmbh.de www.ktkgmbh.de

HRB München 197732 Geschäftsführer: Bernhard Kink Thomas Lottermoser

Kreissparkasse München BLZ 70250150 Konto 22838445 USt-ID. DE282395272

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.