(165 days)
Not Found
No
The summary describes a material (PMMA discs) used in a CAD/CAM process for dental restorations. The process involves design using CAD technology and machining using CAM, but there is no mention or indication of AI/ML being used in the design, manufacturing, or analysis of the material or the resulting restorations. The performance studies focus on material properties.
No.
This device is a milling blank used to fabricate temporary crowns and bridgeworks. It is a material used for restoration and does not directly provide therapy.
No
This device is a material (PMMA milling blanks) used for fabricating dental restorations (temporary crowns and bridgeworks). It is a manufacturing component, not a tool for diagnosing medical conditions.
No
The device is a physical milling blank made of PMMA, not a software application. While it is used in conjunction with CAD/CAM software, the device itself is a material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of long-term temporary crown and bridgework. This is a dental restoration, not a diagnostic test performed on biological samples.
- Device Description: The device is a milling blank used to create a physical dental prosthesis. It does not interact with biological samples for diagnostic purposes.
- Lack of Diagnostic Function: The description focuses on the material properties and the process of creating a dental restoration. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the material (tensile strength, bending strength, etc.), which are relevant to the structural integrity of a dental restoration, not the accuracy of a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
DENTALOS PLUS discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined by use of the CAD/CAM technique.
DENTALOS PLUS discs are recommended for manufacturing substructures of single tooth crowns and bridgeworks with up to two pontics.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
DENTALOS PLUS discs are milling blanks composed of hot cured polymethylmethacrylate (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 DENTALOS PLUS 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. DENTALOS PLUS discs are offered as monochrome discs (DENTALOS PLUS MONO) in nine different shades and as multicolored discs (DENTALOS PLUS MULTICOLOR) in five 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
Tooth/teeth for crown and bridgework.
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 comparability of DENTALOS PLUS blanks to the predicate devices DENTALOS PLUS blanks a series of testing was performed - in particular tensile strength, elastic limit, bending strength, e-module, water solubility and water absorption. The results of this testing showed that the physical properties and performance of the subject device are comparable to the identified predicate devices. The standards used for performance testing are ISO 10477:2004, ISO 527-1:2012, and ISO 572-2:2012.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Dentalplus GmbH Mr. Ralf Rueth CEO Kohlgrub 5 Samberg, 83122 DE GERMANY
Re: K152215
Trade/Device Name: Dentalos Plus Mono, Dentalos Plus Multicolor Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 4, 2015 Received: December 24, 2015
Dear Mr. Rueth:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K152215
Device Name:
DENTALOS PLUS MONO DENTALOS PLUS MULTICOLOR
Indications For Use:
DENTALOS PLUS discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined by use of the CAD/CAM technique.
DENTALOS PLUS discs are recommended for manufacturing substructures of single tooth crowns and bridgeworks with up to two pontics.
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 NEED-ED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
.
K152215
510[k] Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | DentalPlus GmbH |
|---|---|
| Submitter Address | |
| Phone Number | |
| Fax Number | |
| Contact Person | Kohlgrub 5, D-83122 Samerberg, Germany |
| +49-8032-9892007 | |
| +49-8032-9882790 | |
| Ralf Gerschütz Rüth | |
| Date summary was prepared | |
| Device Trade Name(s) | December 4, 2015 |
| DENTALOS PLUS MONO | |
| DENTALOS PLUS MULTICOLOR | |
| Classification Name | |
| C.D.R. section number | |
| Product Code | |
| Regulatory Class | |
| Predicate Devices | Temporary Crown and Bridge Resin |
| 872.3770 | |
| EBG | |
| Class II | |
| K122025 | |
| BRIGHTGLASS | |
| BRIGHTGLASS M | |
| Device Description | DENTALOS PLUS discs are milling blanks composed of hot |
| cured polymethylmethacrylate (PMMA). | |
| They are intended to be used by dental professionals e.g. den- | |
| tal 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 DENTALOS PLUS | |
| Discs. | |
| In a further step the milled workpiece can be individually char- | |
| acterized with veneering materials and polished for to improve | |
| the aesthetic appearance of the finished restoration. | |
| DENTALOS PLUS discs are offered as monochrome discs | |
| (DENTALOS PLUS MONO) in nine different shades and as | |
| multicolored discs (DENTALOS PLUS MULTICOLOR) in five | |
| shades, all discs in different thicknesses. |
4
| Submitter: | Premarket Notification: Traditional 510(k) |
|---|---|
| DentalPlus GmbH | Temporary Crown and Bridge Resin (PMMA) |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| The state of the course of the course of the course of the course of |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Company of Concession of Children and |
|---|
| Indications for Use | DENTALOS PLUS Discs are milling blanks consisting of
polymethylmethacrylate (PMMA) and are designed for the fab-
rication of long-term temporary crown and bridgework using
the CAD/CAM technique. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DENTALOS PLUS Discs are recommended for manufacturing
substructures of single tooth crowns and bridgework with up to
two pontics. |
| Performance Testing | In order to demonstrate comparability of DENTALOS PLUS
blanks to the predicate devices DENTALOS PLUS blanks a
series of testing was performed - in particular tensile strength,
elastic limit, bending strength, e-module, water solubility and
water absorption. |
| | The results of this testing showed that the physical properties
and performance of the subject device are comparable to the
identified predicate devices. |
| | The standards used for performance testing are ISO
10477:2004, ISO 527-1:2012, and ISO 572-2:2012. |
Summary of Technological Characteristics
| Devices | DENTALOS PLUS MONO
DENTALOS PLUS MULTICOLOR | BRIGHTGLASS | BRIGHTGLASS M |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k) Number | K152215 | K122025 | |
| Manufacturer | DentalPlus GmbH | KTK Medical Supplies GmbH | |
| Trade Name [s] | DENTALOS PLUS MONO Blanks
DENTALOS PLUS MULTICOLOR | BRIGHTGLASS
BRIGHTGLASS M | |
| Shape [delivery form] | Blanks (discoidal) | Blanks (discoidal) | |
| Classification | 872.3770 | 872.3770 | |
| Product Code | EBG | EBG | |
| Intended Use | DENTALOS PLUS devices are milling blanks consisting of polymethyl-
methacrylate (PMMA) and designed
for the fabrication of long-term tem-
porary crown and bridgework using
the CAD/CAM technique.
DENTALOS PLUS blanks are rec-
ommended for manufacturing sub-
structures of single tooth crowns and
bridgework with up to two pontics. | BRIGHTGLASS Discs are milling
blanks consisting of polymethyl-
methacrylate (PMMA) and designed
for the fabrication of long-term tem-
porary crown and bridgework using
the CAD/CAM technique.
BRIGHTGLASS Discs are recom-
mended for manufacturing substruc-
tures of single tooth crowns and
bridgework with up to two pontics. | |
| Intended Customers | Professional dental technicians | Professional dental technicians | |
| Further Processing | Milling in CAM milling centers using
CAD/CAM technique | Milling in CAM milling centers using
CAD/CAM technique | |
| Types | monochrome blanks
transitional shaded blanks
different shades | monochrome blanks
transitional shaded blanks
different shades | |
Section 5
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page 5 - 3
5
| Devices | DENTALOS PLUS MONO
DENTALOS PLUS MULTICOLOR | | BRIGHTGLASS
BRIGHTGLASS M | |
|----------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Fabrication method | Granulate material (resin) plasticized
through heat and sprayed into a form
under high pressure | | Granulate material (resin) plasticized
through heat and sprayed into a form
under high pressure | |
| Material Composition | hot cured Polymethylmethacrylate
(PMMA) > 99,9 %
Different pigments - total percentage
99,9 %
Different pigments - total percentage