DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.

Device Description

DD cube ONE ML are dental milling blanks made of yttria-stabilized pre-sintered zirconium dioxide, showing a super high translucency and a high strength and fracture toughness at the same time. The ceramics are of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-223). The material is suited ideally for crowns and bridges for both, the anterior and posterior region.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: DD cube ONE ML (Dental Zirconia Blanks)
Predicate Device: K170885: Dental Direkt GmbH DD cube ONE (former DD cubeX2 HS)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Requirement from ISO 6872:2015)	Required Value	Achieved Value	Passed / Failed
Uniformity (Clause 5.1)	N/A (Visual Inspection)	-	Passed
Freedom from extraneous materials (Clause 5.2.1)	N/A (Visual Inspection)	-	Passed
Activity concentration of uranium 238 (Clause 5.2.2)	< 1.0 Bq/g	< 0.03 Bq/g	Passed
Flexural strength (Clause 4)	800 MPa	1100 MPa	Passed
Chemical solubility (Clause 4)	< 100 µg/cm²	15.3 µg/cm²	Passed
Information supplied by the manufacturer (Clause 8.1.3)	Detailed information regarding handling and treatment	- (Confirmed by review of supplied information)	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the non-clinical tests (physical/chemical properties). It mentions that "DD cube ONE ML products were tested by an accredited testing laboratory" but doesn't specify how many samples were tested for each criterion.
Data Provenance: The tests were performed by an "accredited testing laboratory." The country of origin of this laboratory is not specified. The tests are "non-clinical tests," implying a laboratory setting rather than patient data. The study is not a clinical study, so terms like "retrospective" or "prospective" are not applicable in that context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the provided study is a non-clinical, laboratory-based testing report for material properties (physical and chemical), not a diagnostic or AI-assisted clinical device requiring expert ground truth for interpretation. Visual inspections were performed, but no specific "experts" or their qualifications are detailed beyond the testing laboratory's accreditation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. The evaluation of physical and chemical properties in a laboratory setting typically does not involve adjudication by multiple experts in the sense of clinical image review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
The device is "Porcelain Powder for Clinical Use" (specifically, dental zirconia blanks), which is a material used for dental restorations, not a diagnostic or AI-assisted device that would involve human readers interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study was not done.
This device is a material, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through measurement against established scientific and regulatory standards for material properties.
- For physical and chemical properties (flexural strength, chemical solubility, uranium 238 activity concentration), the "ground truth" was the required value specified in the DIN EN ISO 6872:2015 standard.
- For uniformity, freedom from extraneous materials, and information provided, the "ground truth" was adherence to the standard's qualitative requirements, confirmed by visual inspection or documentation review.
The study also relied on biocompatibility testing against EN ISO 10993-1 and EN ISO 10993-5, where the "ground truth" was compliance with biological safety requirements.

8. Sample Size for the Training Set

This information is not applicable as the device is a dental material, not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a dental material, not a machine learning or AI device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

Dental Direkt GmbH Vera Escher Regulatory Affairs Manager International Industriezentrum 106-108 Spenge, 32139 GERMANY

February 14, 2019

Re: K183569

Trade/Device Name: DD cube ONE ML Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 9, 2019 Received: January 15, 2019

Dear Vera Escher:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.02.14

For Tina Kiang, Ph.D. Acting 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): K183569

Device Name: DD cube ONE ML

Indications for Use:

DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.

Prescription Use	X
(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)

Page 1 of 1

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Page 1 of 2		510(k) Number:	K183569
		Date:

510(k) Summary

Submitter of 510(k)	Dental Direkt GmbHIndustriezentrum 106-10832139 Spenge / Germany
Contact Person	Uwe Greitens, CEOPhone: +49 5225 86319-0Fax: +49 5225 86319-99u.greitens@dentaldirekt.de
Regulatory Correspondent:	Vera Escher, Manager Regulatory AffairsPhone:+49 5225 86319-0Fax: +49 5225 86319-99v.escher@dentaldirekt.de
Establishment Registration No.	3008347275
Date Prepared	2018/12/18
Trade Name of Device	DD cube ONE ML
Common Name	Powder, Porcelain
Classification Name	Porcelain Powder for clinical use
Regulation Number	21 CFR 872.6660
Classification Product Code	EIH
Panel	Dental
Classification	Class II
Predicate Device	K170885:Dental Direkt GmbHDD cube ONE (former DD cubeX2 HS)

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Indications for Use	DD cube ONE ML dental zirconia blanks areindicated for crowns, multi-unit bridges and inlaybridges. Applications include both, anterior andposterior bridges.
Device Description	DD cube ONE ML are dental milling blanks made ofyttria-stabilized pre-sintered zirconium dioxide,showing a super high translucency and a highstrength and fracture toughness at the same time.The ceramics are of type II (not powder), Class 5according to DIN EN ISO 6872 (FDA RecognitionNumber 4-223). The material is suited ideally forcrowns and bridges for both, the anterior andposterior region.
Technological Characteristics	The technological characteristics of the modifieddevice are the same as those of the legallymarketed unmodified device. Both devices aremade of yttria-stabilized zirconia ceramics of highquality and with outstanding material properties. Theonly difference to the unmodified device is theshade. The unmodified device DD cube ONE is awhite blank and the new device is a multilayer-blank. The base material is identical, and the newdevice only contains small amounts of coloringoxides to achieve a natural tooth shade directly aftersintering. The blank has different layers: The upperpart contains less coloring oxides and therefore isbrighter than the medium dentine area and thedarker bottom layer which contain more coloringoxides.
Comparison ofRequired TechnologyCharacteristics	The following table shows a summary of thetechnological characteristics of DD cube ONEML (modified product) compared to the predicatedevice.

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Comparison of Required Technology Characteristics
Feature	Unmodifiedproduct	Modified product	Comment
Trade name	DD cube ONE	DD cube ONE ML	n.a.
510(k)	K170885	this submission	n.a.
Product code	EIH	EIH	Same
Regulatory class	Class II	Class II	Same
Manufacturer	Dental Direkt GmbH	Dental Direkt GmbH	Same
Intended use	DD cube ONEdental zirconiablanks are indicatedfor crowns, multi-unit bridges andinlay bridges.Applications includeboth, anterior andposterior bridges.	DD cube ONE MLdental zirconiablanks are indicatedfor crowns, multi-unit bridges andinlay bridges.Applications includeboth, anterior andposterior bridges.	Same
Multi-unit bridges	Yes	Yes	Same.
Accessories	Yes, coloring liquids	None.	The application ofcoloring liquids withthe new product isnot reasonable,since it is alreadycolored.
Feature	Unmodifiedproduct	Modified product	Comment
Chemical composition
ZrO2 + HfO2 + Y2O3 [wt%]	> 99.0	> 99.0	Same
Y2O3 [wt%]	< 8	< 8	Same
Al2O3 [wt%]	< 0.1	< 0.1	Same
Other oxides	< 0.05	≤ 0.8	Minor deviation dueto color oxides butstill below 1%
Physical characteristics [Units]
PerformanceTesting	Tested according toDIN EN ISO 6872	Tested according toDIN EN ISO 6872	Same
Biocompatibility	EN ISO 10993-1, -5	EN ISO 10993-1, -5	Same

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Discussion ofTests Performed	Clinical Tests
	Dental Direkt GmbH did not conduct, nor rely upon, clinicaltests to determine substantial equivalence as dentalceramics that fall under FDA product code EIH have a longhistory in the US.
	Non Clinical Tests
	Non-clinical testing was performed in order to validate theproduct against the company's specified design require-ments according to the following standards:
	EN ISO 10993-1 (biological compatibility) andEN ISO 10993-5 (cytotoxicity)
	DD cube ONE ML products were tested by an accreditedtesting laboratory with respect to biocompatibility. Thelaboratory certified that "the insolubility of the material is incompliance with the requirements of the standard. There isno evidence that hazardous effects will arise by release ofleachable ingredients/residues". Based on the test resultsDD cube ONE ML was classified as eminently suitable foruse in the dental applications.

ISO 6872:2015, Dentistry Ceramic materials . (FDA Recognition # 4-223)

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Requirements acc. to ISO 6872:2015:
RequirementsISO 6872(Clause)	Shortdescription	Requiredvalue	Achievedvalue	Passed /Failed
Uniformity(Clause 5.1)	Checked byvisual inspection	N/A	-	Passed
Freedom fromextraneous materials(Clause 5.2.1)	Checked byvisual inspection	N/A	-	Passed
Physical and chemicalproperties(Clause 5.2.2)	Activityconcentration ofuranium 238	< 1.0 Bq/g	< 0.03 Bq/g	Passed
Physical and chemicalproperties(Clause 4)	Flexuralstrength	800 MPa	1100 MPa	Passed
Physical and chemicalproperties(Clause 4)	Chemicalsolubility	< 100 μg/cm²	15.3 μg/cm²	Passed
Information supplied bythe manufacturer(Clause 8.1.3)	Detailedinformationregarding thehandling andtreatment of thematerial	N/A	-	Passed

Substantial Equivalence Conclusion

Dental Direkt GmbH believes that DD cube ONE ML is as safe and effective as the predicate device 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 as the predicate device. The new device was verified in accordance with the above FDA recognized standard. Dental Direkt GmbH therefore believes that DD cube ONE ML (modified device) is substantially equivalent to the legally marketed unmodified device.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
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.(b)
Classification. Class II.