(118 days)
DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Dental milling blanks made of DD Bio Z, DD Bio ZX 2 , DD Bio ZX 2 color are semi-finished products out of yttrium-stabilized, pre-sintered zirconium dioxide for the fabrication of crown- and bridge- frameworks on commercial CAD/CAM systems or hand-operated copy-milling machines, with outstanding biocompatibility and mechanical properties.
This document, a 510(k) submission for dental milling blanks (DD Bio Z, DD Bio ZX2, DD Bio ZX2 color), focuses on demonstrating substantial equivalence to a predicate device (K093748: DD Bio Z, DD Bio Z transpa) rather than establishing novel safety and effectiveness through a comprehensive study with acceptance criteria.
Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory document. I will fill in the available information and explicitly state when information is not provided.
Acceptance Criteria and Device Performance for DD Bio Z, DD Bio ZX2, DD Bio ZX2 color
This submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, as opposed to proving de novo safety and effectiveness through clinical trials with defined acceptance criteria. The primary method of demonstrating equivalence here is through non-clinical testing to voluntary design standards and comparison of material properties.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense of a clinical study endpoint. Instead, it relies on conformance to a voluntary design standard (ISO 6872:2008) and comparison of key material properties to the predicate and to the intended use. The performance reported below focuses on the material specifications as compared to the predicate.
| Characteristic | Acceptance Criteria (based on ISO 6872:2008 or predicate specs) | Reported Device Performance (DD Bio Z / DD Bio ZX2) | Notes |
|---|---|---|---|
| Biocompatibility | Conformance to DIN EN ISO 10993-1, 10993-5 (cytotoxicity) | Passed specified biocompatibility tests | "DD Bio Z zirconia was tested by an accredited testing laboratory regarding cytotoxicity (according to DIN EN ISO 10993-5) and biological compatibility (according to DIN EN ISO 10993-1)." Chemical analysis for contaminants was also done. The document states, "Based on the established use of the identical material in cleared devices, and on testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008, additional biocompatibility testing is not considered necessary." |
| Chemical composition | Equivalent to predicate (allowing for minor improvements) | ZrO2 + HfO2 + Y2O3: Same as predicate Y2O3: Same as predicate Al2O3: DD Bio Z: <0.15%, DD Bio ZX2: <0.15% (Predicate DD Bio Z transpa: <0.1%) | The key difference is a "slightly change in the chemical composition by increasing the alumina content for the translucent variant DD Bio ZX2." This change is presented as an improvement for DD Bio ZX2 compared to the predicate DD Bio Z transpa, enhancing flexural strength. The overall material group (3Y-TZP) remains the same. |
| Flexural Strength | Conformance to ISO 6872:2008 (specifications not detailed here) and >= predicate (DD Bio Z: 1000 ± 200 MPa) | DD Bio Z / DD Bio ZX2: 1200 ± 200 MPa | The reported flexural strength for DD Bio Z / DD Bio ZX2 (1200 ± 200 MPa) is higher than the predicate DD Bio Z (1000 ± 200 MPa) and the original DD Bio Z transpa. This is presented as an improvement due to the increased Alumina content in DD Bio ZX2. The document states: "The increase of Alumina content in the raw material as used for DD Bio ZX2 compared to the predicate DD Bio Z transpa leads to an increase in flexural strength." |
| Risk Management | Adherence to ISO 14971 | Device designed to eliminate or mitigate known health hazards as per ISO 14971 | The device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to ISO 14971 "Medical devices - Application of risk management to medical devices". |
| Material Group | Stay the same (3Y-TZP) | Stayed the same (3Y-TZP) | "The material group 3Y-TZP for the products in this submission and the predicate submission stayed the same." |
| Intended Use | Identical to predicate | "for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges." | "All ceramic zirconia products incorporates the same intended use with the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of number of devices/cases tested for each specific property. The submission refers to "testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008" and "non-clinical testing... to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008." The specific methodology or sample sizes for these tests are not provided in this summary.
- Data Provenance: Not specified in the provided summary. However, the submitter is "Dental Direkt of Amerika UG (haftungsbeschraenkt)" located in Germany, suggesting testing may have been conducted there or by affiliated accredited laboratories.
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 science and biocompatibility assessment, not a diagnostic imaging study requiring expert interpretation for "ground truth." The "truth" is established by laboratory measurements against defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process described, as this is related to material properties and biocompatibility testing against objective standards.
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 device is a dental milling blank (a material), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the material properties and biocompatibility is established by:
- Physical and Chemical Measurements: Laboratory tests against established material science parameters (e.g., flexural strength, chemical composition).
- Standard Conformance: Adherence to recognized international standards such as DIN EN ISO 10993-1, ISO 10993-5 (biocompatibility), and ISO 6872:2008 (dental ceramic specifications).
8. The sample size for the training set
Not applicable. This device is a physical material, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in black and create a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2015
Dental Direkt of Amerika UG (haftungsbeschraenkt) c/o Mr. Achim Rosner General Manager Pappelweg 6 32139 Spenge GERMANY
Re: K142987
Trade/Device Name: DD Bio Z, DD Bio ZX2, DD Bio ZX2 color Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: November 10, 2014 Received: November 13, 2014
Dear Mr. Rosner:
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.
{1}------------------------------------------------
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 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): 142987
Device Name: DD Bio Z, DD Bio ZX2, DD Bio ZX2 color
Indications for Use:
DD Bio Z-dental 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
{3}------------------------------------------------
Section 5
510(k) Summary
{4}------------------------------------------------
Page 1 of 2
| 510(k) Number: | |
|---|---|
| ---------------- | -- |
Date: ________________________________________________________________________________________________________________________________________________________________________
510(k) Summary
| Submitter of 510(k) | Dental Direkt of Amerika UG (haftungsbeschraenkt)Pappelweg 632139 SpengeGermany |
|---|---|
| Contact Person | Gerhard de Boer (General Manager)Tel 0049 / 5225-8 6319-0Fax: 0049 / 5225-8 6319-99 |
| Establishment RegistrationNumber | 3008347275 |
| Date Prepared | November 10, 2014 |
| Proprietary Name | DD Bio Z, DD Bio ZX 2 , DD Bio ZX 2 color |
| Common name | Powder, Porcelain |
| Classification name | Porcelain powder for clinical use(21 CFR 872.6660, Product Code EIH) |
| Classification | Class II |
| Predicate Devices | K093748:Dental Direkt of Amerika UG (haftungsbeschraenkt)DD Bio Z, DD Bio Z transpa |
| Device Description andIntended Use | Dental milling blanks made of DD Bio Z, DD Bio ZX 2 orDD Bio ZX 2 color are semi-finished products out ofyttrium-stabilized, pre-sintered zirconium dioxide forthe fabrication of crown- and bridge- frameworks oncommercial CAD/CAM systems or hand-operatedcopy-milling machines, with outstandingbiocompatibility and mechanical properties.DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications includeboth anterior and posterior bridges. |
{5}------------------------------------------------
Page 2 of 2
510(k) Number: K142987
Date:__
Biocompatibility All patient contacting materials used in the device are identical to those used in other FDA cleared devices, in formulation and processing, and no other chemicals have been added (e.g. plasticizers, fillers, cleaning agents, mold release agents, etc.). As usual for this type of device, the product has direct/indirect (salviamediated), permanent (> 30 days) contact with oral mucosa and hard tooth tissue (enamel, dentin). According to DIN EN ISO 10993-1 biological effects which have to be considered for this type of device to prove biological safety are cytotoxicity, tissue/ mucosa irritation, sensitization, systemic toxicity, genotoxicity/ carcinogenicity and chronic toxicity.
DD Bio Z zirconia was tested by an accredited testing laboratory regarding cytotoxicity (according to DIN EN ISO 10993-5) and biological compatibility (according to DIN EN ISO 10993-1). To prove biocompatibility chemical analysis of organic and inorganic contaminants have been done. This highly sensitive chemical and biological test methods substantiated the known inert material properties and justifies the non-performance of additional toxicological tests. The material was classified as eminently suitable for use in the dental sector.
Based on the established use of the identical material in cleared devices, and on testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008, additional biocompatibility testing is not considered necessary.
- Dental Direkt of Amerika UG (haftungsbeschraenkt) did not Clinical and Non-Clinical Testing conduct nor rely upon clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008
- Risk Management The device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to ISO 14971 "Medical devices - Application of risk management to medical devices".
- Technological The difference between the products of the predicate device
{6}------------------------------------------------
characteristics K093748 and the products in the current 510(k) submission is a modification of raw materials used in the manufacture of milling blanks. Even if the material group 3Y-TZP staved the same, the properties differ significantly and are improved. The indication of use for the predicate K093748 "Dental Blanks made from DD Bio Z or DD Bio Z transpa are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges" is the same as for the new product, only the product names were summarized as "DD Bio Z-dental blanks" in the new indication for use.
The modification is mainly a slightly change in the chemical composition by increasing the alumina content for the translucent variant DD Bio ZX2. The raw material as used for the predicate device DD Bio Z transpa had nearly no alumina contained. The missing alumina in the zirconia structure and the recommendation of a higher final sintering temperature lead to an increased grain growth and more translucency but a lowered flexural strength in comparison to DD Bio Z. Compared to DD Bio Z transpa the new DD Bio ZX2 material with an increased alumina content is an improvement. DD Bio ZX2 is still more translucent than the DD Bio Z material even if the sintering temperature recommendation is now the same as for DD Bio Z and the flexural strength was enhanced in comparison to the DD Bio Z transpa material. Furthermore, the utilization of colouring oxides was excluded in the first submission.
The following table shows the significant similarities and
Substantial Equivalence Comparison Table
differences between the predicate products and this submission
| Submitter | Dental Direkt | Dental Direkt |
|---|---|---|
| Device name | DD Bio Z /DD Bio ZX²(incl. pre-coloredvariants) | DD Bio Z /DD Bio Z transpa |
| 510(k) No. | this submission | K093748 |
| Product code | EIH | EIH |
| Regulatory Class | Class II | Class II |
{7}------------------------------------------------
| Indications for Use | DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges. | Dental Blanks made from DD Bio Z or DD Bio Z transpa are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges. |
|---|---|---|
| Chemical composition [wt%]: | DD Bio Z / DD Bio ZX2 | DD Bio Z / DD Bio Z transpa |
| ZrO2 + HfO2 + Y2O3 | same | same |
| Y2O3 | same | same |
| Al2O3 | same <0,15 | same <0,1 |
| Flexural strength [MPa] | same 1200 ± 200 | same 1000 ± 200 |
Brief summary:
Substantial Equivalence Conclusion
The material group 3Y-TZP for the products in this submission and the predicate submission stayed the same. All ceramic zirconia products incorporates the same intended use with the predicate device. The increase of Alumina content in the raw material as used for DD Bio ZX2 compared to the predicate DD Bio Z transpa leads to an increase in flexural strength.
Beside this improvement the technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. The colouring dopants in pre coloured variants have no influence on material properties They have similar labels and instructions for use (see chapter 21 "Predicates").
Dental Direkt of Amerika UG (haftungsbeschraenkt) believes that DD Bio Z-dental blanks are as safe and effective as the predicate devices when used as instructed by knowledgeable and trained personnel, and are substantially equivalent to the legally marketed predicate devices.
{8}------------------------------------------------
§ 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.