(90 days)
Not Found
No
The description focuses on the material properties and manufacturing process (CAD/CAM milling) of the dental discs, with no mention of AI or ML being used in the design or fabrication process.
No
The device, BRIGHTGLASS Discs, is a milling blank used to fabricate temporary dental restorations. It is a material used by dental professionals, not a device directly applied for therapeutic purposes or to treat diseases/conditions.
No
The device is a material (milling blanks) used for fabricating dental restorations (crowns and bridgework), not for diagnosing medical conditions.
No
The device described is a physical milling blank made of PMMA, used for fabricating dental restorations. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- BRIGHTGLASS Discs Function: BRIGHTGLASS Discs are materials used to fabricate dental restorations (crowns and bridges). They are a component in a manufacturing process, not a device that analyzes biological specimens.
- Intended Use: The intended use is for the fabrication of temporary dental prosthetics, not for diagnostic testing.
- Device Description: The description focuses on the material composition and the manufacturing process (CAD/CAM milling), not on analyzing biological samples.
Therefore, BRIGHTGLASS Discs fall under the category of dental materials or devices used in the fabrication of dental prosthetics, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
EBG
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 (BRIGHTGLASS) in six different shades and as multicolored disc (BRIGHT-GLASS M) in up to four shades, all discs in different thicknesses.
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
dental professionals e.g. dental technicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | |
| Phone Number | |
| Fax Number | |
| Contact Person | Industriestr. 16, 82110 Germering, Germany |
| +49-89-8407970 | |
| +49-89-84058896 | |
| Thomas Lottermoser | |
| Date summary was prepared | |
| Device Trade Name(s) | 2012-06-25 |
| BRIGHTGLASS | |
| BRIGHTGLASS M | |
| Classification Name | |
| C.D.R. section number | |
| Product Code | |
| Regulatory Class | |
| Predicate Devices | Temporary Crown and Bridge Resin |
| 872.3770 | |
| EBG | |
| class II | |
| K080182 | |
| ZENO PMMA Discs | |
| 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 par- | |
| ticular patient. | |
| These restorations are designed virtually by dental technicians us- | |
| ing 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 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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1
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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. |
.
.
.
2
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.
3
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.
4
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
5
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.: 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