DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR

K152215 · Dentalplus GmbH · EBG · Jan 19, 2016 · Dental

Device Facts

• Record ID: K152215
• Device Name: DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
• Applicant: Dentalplus GmbH
• Product Code: EBG · Dental
• Decision Date: Jan 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

DENTALOS PLUS discs are hot-cured PMMA milling blanks used by dental technicians to fabricate long-term temporary crowns and bridges. Input data consists of intraoral scans or scans from impressions/models; these are processed via CAD software to design the restoration. The design is then output to a CAM milling center where the disc is machined into the final custom restoration. The milled workpiece may be characterized with veneering materials and polished to improve aesthetics. The device is used in dental laboratories; the final restoration is placed in the patient's mouth by a dentist. The device benefits patients by providing durable, aesthetically customized temporary restorations during the treatment process.

Clinical Evidence

Bench testing only. Performance compared to predicate using ISO 10477:2004, ISO 527-1:2012, and ISO 572-2:2012. Metrics included tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption.

Technological Characteristics

Material: Hot-cured Polymethylmethacrylate (PMMA) >99.9%, pigments <0.1%. Form factor: Discoidal milling blanks. Processing: CAD/CAM milling. Standards: ISO 10477:2004, ISO 527-1:2012, ISO 572-2:2012.

Indications for Use

Indicated for dental professionals/technicians to fabricate long-term temporary crowns and bridgework (up to two pontics) using CAD/CAM milling of PMMA blanks.

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

• BRIGHTGLASS (K122025)
• BRIGHTGLASS M (K122025)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 Address<br>Phone Number<br>Fax Number<br>Contact Person | Kohlgrub 5, D-83122 Samerberg, Germany<br>[phone]<br>[phone]<br>Ralf Gerschütz Rüth |
| Date summary was prepared<br>Device Trade Name(s) | December 4, 2015<br>DENTALOS PLUS MONO<br>DENTALOS PLUS MULTICOLOR |
| 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>K122025<br>BRIGHTGLASS<br>BRIGHTGLASS M |
| Device Description | DENTALOS PLUS discs are milling blanks composed of hot<br>cured polymethylmethacrylate (PMMA).<br>They are intended to be used by dental professionals e.g. den-<br>tal technicians for the fabrication of long-term temporary crowns<br>and bridgeworks as custom-made restorations for the sole use<br>of a particular patient.<br>These restorations are designed virtually by dental technicians<br>using the CAD technology on the basis of intraoral scans or<br>scans from impressions and/or models.<br>The designed restorations can thereafter be machined in all<br>appropriate CAM Milling Centers out of DENTALOS PLUS<br>Discs.<br>In a further step the milled workpiece can be individually char-<br>acterized with veneering materials and polished for to improve<br>the aesthetic appearance of the finished restoration.<br>DENTALOS PLUS discs are offered as monochrome discs<br>(DENTALOS PLUS MONO) in nine different shades and as<br>multicolored discs (DENTALOS PLUS MULTICOLOR) in five<br>shades, all discs in different thicknesses. |

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| Submitter: | Premarket Notification: Traditional 510(k) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DentalPlus GmbH | Temporary Crown and Bridge Resin (PMMA) |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>The state of the course of the course of the course of the course of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>--------------------------------------------------------------------------------------------------------------<br>Company of Concession of Children and<br>----------------------------------- |

| Indications for Use | DENTALOS PLUS Discs are milling blanks consisting of<br>polymethylmethacrylate (PMMA) and are designed for the fab-<br>rication of long-term temporary crown and bridgework using<br>the CAD/CAM technique. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DENTALOS PLUS Discs are recommended for manufacturing<br>substructures of single tooth crowns and bridgework with up to<br>two pontics. |
| Performance Testing | In order to demonstrate comparability of DENTALOS PLUS<br>blanks to the predicate devices DENTALOS PLUS blanks a<br>series of testing was performed - in particular tensile strength,<br>elastic limit, bending strength, e-module, water solubility and<br>water absorption. |
| | The results of this testing showed that the physical properties<br>and performance of the subject device are comparable to the<br>identified predicate devices. |
| | The standards used for performance testing are ISO<br>10477:2004, ISO 527-1:2012, and ISO 572-2:2012. |

# Summary of Technological Characteristics

| Devices | DENTALOS PLUS MONO<br>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<br>DENTALOS PLUS MULTICOLOR | BRIGHTGLASS<br>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-<br>methacrylate (PMMA) and designed<br>for the fabrication of long-term tem-<br>porary crown and bridgework using<br>the CAD/CAM technique.<br><br>DENTALOS PLUS blanks are rec-<br>ommended for manufacturing sub-<br>structures of single tooth crowns and<br>bridgework with up to two pontics. | BRIGHTGLASS Discs are milling<br>blanks consisting of polymethyl-<br>methacrylate (PMMA) and designed<br>for the fabrication of long-term tem-<br>porary crown and bridgework using<br>the CAD/CAM technique.<br><br>BRIGHTGLASS Discs are recom-<br>mended for manufacturing substruc-<br>tures of single tooth crowns and<br>bridgework with up to two pontics. | |
| Intended Customers | Professional dental technicians | Professional dental technicians | |
| Further Processing | Milling in CAM milling centers using<br>CAD/CAM technique | Milling in CAM milling centers using<br>CAD/CAM technique | |
| Types | monochrome blanks<br>transitional shaded blanks<br>different shades | monochrome blanks<br>transitional shaded blanks<br>different shades | |

Section 5

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| Devices | DENTALOS PLUS MONO<br>DENTALOS PLUS MULTICOLOR | | BRIGHTGLASS<br>BRIGHTGLASS M | |
|----------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Fabrication method | Granulate material (resin) plasticized<br>through heat and sprayed into a form<br>under high pressure | | Granulate material (resin) plasticized<br>through heat and sprayed into a form<br>under high pressure | |
| Material Composition | hot cured Polymethylmethacrylate<br>(PMMA) > 99,9 %<br>Different pigments - total percentage<br>< 0,1 % | | hot cured Polymethylm ethacrylate<br>(PMMA) > 99,9 %<br>Different pigments - total percentage<br>< 0,1 % | |
| physical properties | e module<br>tensile strength<br>Elastic Limit<br>Bending strength<br>water absorption<br>water solubility | 3370 MPA<br>76,3 MPA<br>70 MPA<br>106 MPA<br>19,36 µg/m³<br>< 1µg/m³ | e module<br>tensile strength<br>Elastic Limit<br>Bending strength<br>water absorption<br>water solubility | 3370 MPA<br>76,3 MPA<br>70 MPA<br>106 MPA<br>19,36 µg/m³<br>< 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.