DD cubeX2

K150196 · Dental Direkt GmbH · EIH · Mar 26, 2015 · Dental

Device Facts

• Record ID: K150196
• Device Name: DD cubeX2
• Applicant: Dental Direkt GmbH
• Product Code: EIH · Dental
• Decision Date: Mar 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.

Device Story

DD cubeX2 is a semi-finished dental blank composed of yttrium-stabilized pre-sintered zirconium dioxide. Used by dental professionals in clinical settings, the blanks are processed via commercial CAD/CAM systems or hand-operated copy milling machines to produce dental crowns and bridge frameworks. The device includes optional coloring fluid accessories (DD Bio ZX2 monolith zero) to enhance aesthetic matching to natural teeth. The material is sintered to achieve final physical properties. The output is a custom-milled dental restoration that provides structural support and aesthetic replacement for missing or damaged tooth structure. The device benefits patients by providing durable, high-translucency ceramic restorations.

Clinical Evidence

Bench testing only. No clinical data was conducted or relied upon. Testing included biocompatibility (EN ISO 10993-1, -5) and mechanical/physical characterization per DIN EN ISO 6872:2008. Results confirmed flexural strength > 720 MPa (exceeding the 500 MPa requirement) and chemical solubility of 15 µg/cm² (well below the 2000 µg/cm² limit).

Technological Characteristics

Yttrium-stabilized pre-sintered zirconium dioxide (ZrO2 + HfO2 + Y2O3 > 99.0 wt%). Class 5 dental ceramic per DIN EN ISO 6872. Flexural strength > 720 MPa; E modulus > 210 GPa; density > 6.0 g/cm³. Accessories include coloring liquids. Biocompatibility per EN ISO 10993-1 and -5. Form factor: semi-finished dental blanks for milling.

Indications for Use

Indicated for patients requiring dental restorations including crowns, multi-unit bridges (max 3 elements), and inlay bridges in anterior or posterior regions.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• DD Bio Z-transpa (K093748)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

Dental Direkt GmbH Mr. Uwe Greitens Authorized Officer Industriezentrum 106-108 32139 Spenge GERMANY

Re: K150196

Trade/Device Name: DD cubeX2 and accessories Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: February 23, 2015 Received: February 25, 2015

Dear Mr. Greitens:

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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 (if known): _K150196

Device Name: DD cubeX2 and accessories

### Indications for Use:

Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### K150196 510(k) Number:

# 510(k) Summary

| Submitter of 510 (k) | Dental Direkt GmbH<br>Industriezentrum 106-108<br>32139 Spenge / Germany |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | U. Greitens, Authorized Officer<br>Phone: [phone] / Fax: [phone] |
| Establishment<br>Registration Number | 3008347275 |
| Date Prepared | January 2015 |
| Trade Name of Device | <i>DD cubeX²</i> and accessories |
| Common Name | Powder, Porcelain |
| Classification Name | Porcelain powder for clinical use |
| Regulation Number | 21 CFR 872.6660 |
| Product Code | EIH |
| Panel | Dental |
| Classification | Class II |
| Name of legally<br>marketed device | <i>DD Bio Z-transpa</i> (K093748) |
| Indications for Use | Dental blanks made from <i>DD cubeX²</i> are indicated for crowns,<br>multi-unit bridges (up to a maximum of three elements) and<br>inlay bridges. Applications include both, anterior and posterior<br>bridges. |
| Device Description | <i>DD cubeX²</i> is a semi-finished dental blank made of yttrium sta<br>bilized pre-sintered zirconium dioxide, which has a super high<br>translucency. The ceramics is of type II (not powder), Class 5<br>according to DIN EN ISO 6872 (FDA Recognition Number 4-<br>178). The <i>DD cubeX²</i><br>dental blanks are designed for milled<br>production of crowns and bridge frameworks on commercial<br>CAD/CAM systems or hand-operated copy milling machines. |

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The material is suited ideally for bridges up to 3 elements for both, the anterior and posterior region. The accessories comprises the DD Bio ZX2 monolith zero, which is a coloring fluid for zirconia restorations made from yttrium stabilized pre-sintered zirconium dioxide of different degree of translucency.

### Comparison of Required Technology Characteristics

The following table shows a summary of the technological characteristics of DD cubeX2 (modified product) compared to the predicate (Unmodified product) device.

| Comparison of Required Technology Characteristics | | | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature | Unmodified product | Modified product | Comment | |
| Trade name | DD Bio Z-transpa | DD cubeX2 | n.a | |
| 510(k) | K093748 (Annex 5) | this submission | n.a | |
| Product code | EIH | ElH | Same | |
| Regulatory class | Class II | Class II | Same | |
| Manufacturer | Dental Direkt GmbH for-<br>mer Dental Direkt of America<br>UG (haftungsbeschraenkt) | Dental Direkt GmbH | Same | |
| Intended use | Dental blanks made<br>from DD Bio Z transpa<br>are indicated for<br>crowns, multiunit<br>bridges and inlay<br>bridges. Application in-<br>cludes both, anterior<br>and posterior bridges. | Dental blanks made<br>from DD cubeX2 are in-<br>dicated for crowns, mul-<br>tiunit bridges and inlay<br>bridges. Application in-<br>cludes both, anterior<br>and posterior bridges. | Same | |
| Accessories | No | Yes, coloring liquids | This difference offers<br>a better adaptation of<br>dental blank to natu-<br>ral teeth. | |
| Multi-unit bridges | No limitation | Up to a maximum of<br>three elements | Same, if multi-unit<br>bridge has only three<br>elements. | |
| Chemical composition [Units] | | | | |
| ZrO2 + HfO2 + Y2O3<br>[wt%] | > 99.0 | > 99.0 | Same | |
| Y2O3 [wt%] | 5.15 + 0.20 | < 10 | Higher amount of<br>Y2O3 increases cubic<br>phase in zirconium<br>structure leading to<br>higher translucency. | |
| HfO2 [wt%] | < 5 | ca. 0.2 | Higher purity | |
| Al2O3 [wt%] | < 0.1 | < 0.1 | Same | |
| Other oxides | < 0.2 | < 0.05 | Higher purity | |
| Comparison of Required Technology Characteristics | | | | |
| Feature | Unmodified product | Modified product | Comment | |
| Categorization ISO<br>6872 | Class 6 | Class 5 | Class 5 due to restric-<br>tion to 3-element<br>restaurations | |
| Physical characteristics [Units] | | | | |
| Flexural strength [MPa] | 1000 ± 200 | > 720 | Flexural strength is<br>slightly lower, but hig-<br>her than required by<br>DIN EN ISO 6872 for<br>Class 5 dental cera-<br>mics (> 500 MPa). | |
| E modulus [GPa] | > 210 | > 210 | Same | |
| Density<br>(after sintering) [g/cm3] | > 6.0 | > 6.0 | Same | |
| CTE (25-500 °C) [10-6K-1] | 11 | 10 | Same | |
| Fracture toughness<br>[MPa * m1/2] | unknown | 4.8 | n.a | |
| Physical Testing | Tested according to<br>DIN EN ISO 6872 | Tested according to<br>DIN EN ISO 6872 | Same (Tests for<br>modified product<br>comprise coloring fluid<br>accessories) | |
| Biocompatibility | EN ISO 10993-1, -5 | EN ISO 10993-1, -5 | Same (Tests comprise<br>coloring fluid accesso-<br>ries) | |

Special 510(k) DD cubeX2

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### Brief summary

First, DD cubeX2 (modified product) shares de facto all product specifications and characteristics of the predicate device (unmodified device). There is no difference in fundamental scientific technology. Secondly, the modification of the material composition results in a higher translucency of the product, which leads to better aesthetic results. However, it also leads to a lower flexural strength when compared to the unmodified product. This is compensated by restricting the use of DD cubeX2 if used for multi-unit bridges to three element bridges. Finally the Flexural strength testing result of DD cubeX2 (modified product) is considerably higher than required by DIN EN ISO 6872 for class 5 dental ceramics indicated for three element bridges including molar restorations. Thirdly, the two devices are similar in physical and mechanical properties. Also both (for DD cubeX2 (modified product) including coloring fluid accessories) their safety and effectiveness have been verified by appropriate FDA recognized standards.

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Through they are not identical in chemical material composition, such difference will not influence the core usage of the device, thus will not affect the devices` substantial equivalence.

Discussion of - Clinical Tests Tests Performed Dental Direkt GmbH did not conduct, nor rely upon, clinical tests to determine substantial equivalence as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US. - Non Clinical Tests Non-clinical testing was performed in order to validate the product against the company's specified design requirements, and to evaluate its safety and effectiveness according to the following standards: EN ISO 10993-1 (biological compatibility) and EN ISO -10993-5 (cytotoxicity) With DD Bio ZX2 monolith zero colored and then sintered DD cubeX2finished products were tested by an accredited testing laboratory with respect to biocompatibility. The laboratory certified that "the insolubility is in compliance with the requirements of the Standard. There is no evidence that effects hazardous to the patient will arise by release of leachable ingredients/contaminants".Based on the test results DD cubeX was classified as eminently suitable for use in the dental applications.

- ISO 6872:2008, Dentistry Ceramic materials (FDA Re- cognition # 4-178)

| Part of Table 4 of Section 13: Test results. | | | | |
|--------------------------------------------------------|------------------------------------------|-------------------|-------------------|--------------------|
| Requirements<br>ISO 6872<br>(Clause) | Short description | Required<br>value | Required<br>value | Passed /<br>Failed |
| Uniformity of the<br>material<br>(Clause 5.1) | Checked by visual in-spection | n.a. | - | Passed |
| Freedom from<br>extraneous materials<br>(Clause 5.2.1) | Checked by visual in-spection | n.a. | - | Passed |
| Physical and chemical<br>properties<br>(Clause 5.2.2) | Activity concentration<br>of uranium 238 | < 1.0 Bq/g | < 0.03 Bq/g | Passed |

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| Part of Table 4 of Section 13: Test results. | | | | |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|-------------------|--------------------|
| Requirements<br>ISO 6872<br>(Clause) | Short description | Required<br>value | Required<br>value | Passed /<br>Failed |
| Physical and chemical<br>properties<br>(Clause 4) | Flexural strength | > 500 MPa | > 720 MPa | Passed |
| Physical and chemical<br>properties<br>(Clause 4) | Chemical solubility | < 2000<br>µg/cm² | 15 µg/cm² | Passed |
| Information supplied by<br>the manufacturer<br>(Clause 8.1.3) | Detailed Information<br>regarding the hand-<br>ling and treatment of<br>the material | | | Passed |

DD Bio ZX2 (modified product) meets the requirements of ISO 6872 as well as the unmodified device. Compared to the legally marketed unmodified device the DD cubeX2 (modified device) has the same high resistance against tension and pressure. The only difference to the unmodified device is the amount of yttrium contained in DD cubeX2 and which does not raise new performance or safety issues.

Substantial Dental Direkt GmbH believes that DD cubeX2 and its Equivalence accessories is as safe and effective as the unmodified device Conclusion when used as instructed by knowledgeable and trained dental personnel. There is no change of the intended Use of the modified device and no difference in fundamental scientific technology. The modified device is made from the same materials and the performance safety and effectiveness has been verified in accordance with the above FDA recognized standards. Dental Direkt GmbH therefore believes that DD cubeX2 (modified device) is substantially equivalent to the leqally marketed unmodified device.