BRIGHTGLASS BRIGHTGLASS M

K122025 · Ktk Medical Supplies GmbH · EBG · Oct 9, 2012 · Dental

Device Facts

• Record ID: K122025
• Device Name: BRIGHTGLASS BRIGHTGLASS M
• Applicant: Ktk Medical Supplies GmbH
• Product Code: EBG · Dental
• Decision Date: Oct 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

BRIGHTGLASS discs are hot-cured PMMA milling blanks used by dental technicians to fabricate long-term temporary crowns and bridges. The process begins with intraoral scans or impressions/models, which are converted into virtual designs using CAD software. These designs are then machined into the final restoration shape using CAM milling centers. The milled workpieces may be individually characterized with veneering materials and polished to improve aesthetics. The device is used in a dental laboratory setting. The output is a custom-made dental restoration that replaces missing or damaged tooth structure, providing temporary functional and aesthetic support for the patient while a permanent restoration is prepared.

Clinical Evidence

Bench testing only. Testing included tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption to demonstrate compatibility with the predicate device.

Technological Characteristics

Hot-cured polymethylmethacrylate (PMMA) milling blanks. Available as monochromatic (BRIGHTGLASS) or multicolored (BRIGHTGLASS M) discs in various thicknesses. Material properties include high homogeneity and surface density. Designed for CAD/CAM milling.

Indications for Use

Indicated for fabrication of long-term temporary crown and bridgework, including substructures for single tooth crowns and bridges with up to two pontics, using CAD/CAM milling.

Regulatory Classification

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.

Predicate Devices

• ZENO PMMA Discs (K080182)

Submission Summary (Full Text)

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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 Address<br>Phone Number<br>Fax Number<br>Contact Person | Industriestr. 16, 82110 Germering, Germany<br>[phone]<br>[phone]<br>Thomas Lottermoser |
| Date summary was prepared<br>Device Trade Name(s) | 2012-06-25<br>BRIGHTGLASS<br>BRIGHTGLASS M |
| Classification Name<br>C.D.R. section number<br>Product Code<br>Regulatory Class<br>Predicate Devices | Temporary Crown and Bridge Resin<br>872.3770<br>EBG<br>class II<br>K080182<br>ZENO PMMA Discs |
| Device Description | BRIGHTGLASS discs are milling blanks composed of hot cured<br>polymethymethacrylate (PMMA).<br>They are intended to be used by dental professionals e.g. dental<br>technicians for the fabrication of long-term temporary crowns and<br>bridgeworks as custom-made restorations for the sole use of a par-<br>ticular patient.<br>These restorations are designed virtually by dental technicians us-<br>ing the CAD technology on the basis of intraoral scans or scans<br>from impressions and/or models.<br>The designed restorations can thereafter be machined in all appro-<br>priate CAM Milling Centers out of BRIGHTGLASS Discs.<br>In a further step the milled workpiece can be individually character-<br>ized with veneering materials and polished for to improve the aes-<br>thetic appearance of the finished restoration. |

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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 [phone] or [phone] 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 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.

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.: [phone] Fax: [phone] [e-mail] www.ktkgmbh.de

HRB München 197732 Geschäftsführer: Bernhard Kink Thomas Lottermoser

Kreissparkasse München BLZ 70250150 Konto 22838445 USt-ID. DE282395272