(55 days)
Not Found
No
The device is a dental material blank and the summary does not mention any AI or ML components.
No
The device is a dental material blank used for creating crowns and bridges, which are restorative rather than therapeutic in nature.
No
The device is a dental material (zirconia blanks) used for fabricating crowns and bridges, not for diagnosing conditions.
No
The device description clearly states it is a dental milling blank made of yttria-stabilized pre-sintered zirconium dioxide, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this is a dental material blank used for creating crowns, bridges, and inlays. It is a material that is placed in the body, not used to test samples from the body.
- The performance studies focus on material properties and biocompatibility. The testing described relates to the physical and chemical characteristics of the zirconia material and its safety for use in the mouth. This is typical for a dental restorative material, not an IVD.
- There is no mention of analyzing biological samples or providing diagnostic information. The purpose of this device is to provide a structural component for dental restorations, not to diagnose a condition or provide information about a patient's health status based on a biological sample.
Therefore, the DD cube ONE ML dental zirconia blanks are a dental material, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
knowledgeable and trained dental personnel.
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)
Non Clinical Tests
Non-clinical testing was performed in order to validate the product against the company's specified design require-ments according to the following standards:
EN ISO 10993-1 (biological compatibility) and EN ISO 10993-5 (cytotoxicity)
DD cube ONE ML products were tested by an accredited testing laboratory with respect to biocompatibility. The laboratory certified that "the insolubility of the material is in compliance with the requirements of the standard. There is no evidence that hazardous effects will arise by release of leachable ingredients/residues". Based on the test results DD cube ONE ML was classified as eminently suitable for use in the dental applications.
ISO 6872:2015, Dentistry Ceramic materials.
Requirements acc. to ISO 6872:2015:
- Uniformity (Clause 5.1): Checked by visual inspection, Passed
- Freedom from extraneous materials (Clause 5.2.1): Checked by visual inspection, Passed
- Physical and chemical properties (Clause 5.2.2): Activity concentration of uranium 238, Required value
§ 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.
0
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
1
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
2
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
3
Page 1 of 2 | 510(k) Number: | K183569 | |
---|---|---|---|
Date: |
510(k) Summary
| Submitter of 510(k) | Dental Direkt GmbH
Industriezentrum 106-108
32139 Spenge / Germany |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Uwe Greitens, CEO
Phone: +49 5225 86319-0
Fax: +49 5225 86319-99
u.greitens@dentaldirekt.de |
| Regulatory Correspondent: | Vera Escher, Manager Regulatory Affairs
Phone:+49 5225 86319-0
Fax: +49 5225 86319-99
v.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 GmbH
DD cube ONE (former DD cubeX2 HS) |
4
| 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. |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Technological Characteristics | The technological characteristics of the modified
device are the same as those of the legally
marketed unmodified device. Both devices are
made of yttria-stabilized zirconia ceramics of high
quality and with outstanding material properties. The
only difference to the unmodified device is the
shade. The unmodified device DD cube ONE is a
white blank and the new device is a multilayer-
blank. The base material is identical, and the new
device only contains small amounts of coloring
oxides to achieve a natural tooth shade directly after
sintering. The blank has different layers: The upper
part contains less coloring oxides and therefore is
brighter than the medium dentine area and the
darker bottom layer which contain more coloring
oxides. |
| Comparison of
Required Technology
Characteristics | The following table shows a summary of the
technological characteristics of DD cube ONE
ML (modified product) compared to the predicate
device. |
5
Comparison of Required Technology Characteristics | |||
---|---|---|---|
Feature | Unmodified | ||
product | 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 ONE | ||
dental zirconia | |||
blanks are indicated | |||
for crowns, multi- | |||
unit bridges and | |||
inlay bridges. | |||
Applications include | |||
both, anterior and | |||
posterior bridges. | DD cube ONE ML | ||
dental zirconia | |||
blanks are indicated | |||
for crowns, multi- | |||
unit bridges and | |||
inlay bridges. | |||
Applications include | |||
both, anterior and | |||
posterior bridges. | Same | ||
Multi-unit bridges | Yes | Yes | Same. |
Accessories | Yes, coloring liquids | None. | The application of |
coloring liquids with | |||
the new product is | |||
not reasonable, | |||
since it is already | |||
colored. | |||
Feature | Unmodified | ||
product | Modified product | Comment | |
Chemical composition | |||
ZrO2 + HfO2 + Y2O3 [wt%] | > 99.0 | > 99.0 | Same |
Y2O3 [wt%] |