(165 days)
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.
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.
The document provided is a 510(k) Summary for a medical device called "DENTALOS PLUS MONO" and "DENTALOS PLUS MULTICOLOR," which are milling blanks made of polymethylmethacrylate (PMMA) for fabricating temporary crowns and bridges. This submission is for establishing substantial equivalence to a predicate device, not for a novel AI/software device.
Therefore, the requested information about acceptance criteria and study details related to AI/software performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document.
The document focuses on demonstrating physical and material property comparability of the new device to a predicate device (BRIGHTGLASS and BRIGHTGLASS M).
However, I can extract the relevant information from the document regarding the performance testing that was conducted:
1. A table of acceptance criteria and the reported device performance
The document reports performance parameters for the "DENTALOS PLUS MONO" and "DENTALOS PLUS MULTICOLOR" devices, and implicitly expects them to be comparable to the predicate devices. The table below presents the reported physical properties. The acceptance criteria are implied to be "comparable to the predicate devices," as stated in the "Performance Testing" section.
| Performance Parameter | Reported Device Performance (DENTALOS PLUS MONO/MULTICOLOR) | Acceptance Criteria (Implicit: Comparable to Predicate) |
|---|---|---|
| e-module | 3370 MPA | 3370 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Tensile Strength | 76.3 MPA | 76.3 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Elastic Limit | 70 MPA | 70 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Bending Strength | 106 MPA | 106 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Water Absorption | 19.36 µg/m³ | 19.36 µg/m³ (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Water Solubility | < 1 µg/m³ | < 1 µg/m³ (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
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 does not specify the sample size for the tests conducted (tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption). It only states that "a series of testing was performed." The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a material properties comparison for a dental device, not an AI/software evaluation requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a material properties comparison, not an AI/software evaluation.
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
Not applicable. This is a material properties comparison, not an AI/software evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material properties comparison, not an AI/software evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on physical and chemical testing specified by ISO standards (ISO 10477:2004, ISO 527-1:2012, and ISO 572-2:2012). These standards define the methods and parameters for evaluating the properties of dental polymer-based materials. The performance of the new device is compared directly to the predicate device based on these objective measurements.
8. The sample size for the training set
Not applicable. This is a material properties comparison, not an AI/software evaluation that involves a training set.
9. How the ground truth for the training set was established
Not applicable. This is a material properties comparison, not an AI/software evaluation that involves a training set.
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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.
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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 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
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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)
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.
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 AddressPhone NumberFax NumberContact Person | Kohlgrub 5, D-83122 Samerberg, Germany+49-8032-9892007+49-8032-9882790Ralf Gerschütz Rüth |
| Date summary was preparedDevice Trade Name(s) | December 4, 2015DENTALOS PLUS MONODENTALOS PLUS MULTICOLOR |
| Classification NameC.D.R. section numberProduct CodeRegulatory ClassPredicate Devices | Temporary Crown and Bridge Resin872.3770EBGClass IIK122025BRIGHTGLASSBRIGHTGLASS M |
| Device Description | DENTALOS PLUS discs are milling blanks composed of hotcured polymethylmethacrylate (PMMA).They are intended to be used by dental professionals e.g. den-tal technicians for the fabrication of long-term temporary crownsand bridgeworks as custom-made restorations for the sole useof a particular patient.These restorations are designed virtually by dental techniciansusing the CAD technology on the basis of intraoral scans orscans from impressions and/or models.The designed restorations can thereafter be machined in allappropriate CAM Milling Centers out of DENTALOS PLUSDiscs.In a further step the milled workpiece can be individually char-acterized with veneering materials and polished for to improvethe aesthetic appearance of the finished restoration.DENTALOS PLUS discs are offered as monochrome discs(DENTALOS PLUS MONO) in nine different shades and asmulticolored discs (DENTALOS PLUS MULTICOLOR) in fiveshades, all discs in different thicknesses. |
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| 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 ofpolymethylmethacrylate (PMMA) and are designed for the fab-rication of long-term temporary crown and bridgework usingthe CAD/CAM technique. |
|---|---|
| DENTALOS PLUS Discs are recommended for manufacturingsubstructures of single tooth crowns and bridgework with up totwo pontics. | |
| Performance Testing | In order to demonstrate comparability of DENTALOS PLUSblanks to the predicate devices DENTALOS PLUS blanks aseries of testing was performed - in particular tensile strength,elastic limit, bending strength, e-module, water solubility andwater absorption. |
| The results of this testing showed that the physical propertiesand performance of the subject device are comparable to theidentified predicate devices. | |
| The standards used for performance testing are ISO10477:2004, ISO 527-1:2012, and ISO 572-2:2012. |
Summary of Technological Characteristics
| Devices | DENTALOS PLUS MONODENTALOS PLUS MULTICOLOR | BRIGHTGLASS | BRIGHTGLASS M |
|---|---|---|---|
| 510(k) Number | K152215 | K122025 | |
| Manufacturer | DentalPlus GmbH | KTK Medical Supplies GmbH | |
| Trade Name [s] | DENTALOS PLUS MONO BlanksDENTALOS PLUS MULTICOLOR | BRIGHTGLASSBRIGHTGLASS 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 designedfor the fabrication of long-term tem-porary crown and bridgework usingthe CAD/CAM technique.DENTALOS PLUS blanks are rec-ommended for manufacturing sub-structures of single tooth crowns andbridgework with up to two pontics. | BRIGHTGLASS Discs are millingblanks consisting of polymethyl-methacrylate (PMMA) and designedfor the fabrication of long-term tem-porary crown and bridgework usingthe CAD/CAM technique.BRIGHTGLASS Discs are recom-mended for manufacturing substruc-tures of single tooth crowns andbridgework with up to two pontics. | |
| Intended Customers | Professional dental technicians | Professional dental technicians | |
| Further Processing | Milling in CAM milling centers usingCAD/CAM technique | Milling in CAM milling centers usingCAD/CAM technique | |
| Types | monochrome blankstransitional shaded blanksdifferent shades | monochrome blankstransitional shaded blanksdifferent shades |
Section 5
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| Devices | DENTALOS PLUS MONODENTALOS PLUS MULTICOLOR | BRIGHTGLASSBRIGHTGLASS M | ||
|---|---|---|---|---|
| Fabrication method | Granulate material (resin) plasticizedthrough heat and sprayed into a formunder high pressure | Granulate material (resin) plasticizedthrough heat and sprayed into a formunder high pressure | ||
| Material Composition | hot cured Polymethylmethacrylate(PMMA) > 99,9 %Different pigments - total percentage< 0,1 % | hot cured Polymethylm ethacrylate(PMMA) > 99,9 %Different pigments - total percentage< 0,1 % | ||
| physical properties | e moduletensile strengthElastic LimitBending strengthwater absorptionwater solubility | 3370 MPA76,3 MPA70 MPA106 MPA19,36 µg/m³< 1µg/m³ | e moduletensile strengthElastic LimitBending strengthwater absorptionwater solubility | 3370 MPA76,3 MPA70 MPA106 MPA19,36 µg/m³< 1µg/m³ |
The only difference between the subject device and the noted predicate device is the addition of further shades of color based on slight variations of the pigments within a range of 0,1 % totally according to their type and percentage.
The information discussed above demonstrates that DENTA-LOS Substantially Equivalence PLUS discs are substantially equivalent to the predicate dental device DENTALOS PLUS 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 DENTALOS PLUS disks shows like the predicate device an extreme high homogeneity and by the high surface density a major bending strength and breaking resistance.
Conclusion
The information discussed above demonstrates that the DEN- TALOS fromation alsouboutially equivalent to to the predicate devices.
§ 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.