(82 days)
Not Found
No
The summary describes dental blanks used in CAD/CAM systems, which are materials for milling. There is no mention of software, algorithms, or any technology that would suggest AI/ML is incorporated into the device itself (the blanks). The description focuses on the material properties and intended use in existing milling systems.
No
The device description states that the dental blanks are "dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridges frameworks". They are materials used to create restorations, not a therapeutic device themselves. They do not directly treat or prevent a disease.
No
The device, "Dental Blanks made from DD Bio Z or DD Bio Z-transpa," is described as a dental material used for fabricating crowns and bridge frameworks. Its intended use is for restoration and not for diagnostic purposes.
No
The device is a dental material (semifinished product) made of 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:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges) for anterior and posterior ridges. This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a dental material (semifinished product) made of zirconium dioxide for milling dental frameworks. This aligns with a material used for fabrication, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 ridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental Blanks made of DD Bio Z or DD Bio Z-transpa are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or handoperated copy-milling machines. machines with outstanding biocompatibility and high resistance against tension and pressure.
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
Not Found
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)
Clinical and Non-Clinical Testing did not 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 standards: ANSI ADA Specifications No. 69:1999 ISO 6872:2008
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072569 Metoxit CAM blanks, K081263 H.C. Starck Ceramics StarCeram, K051462 DENTSPLY International Cercon Base
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Dental Direkt of Amerika UG (haftungsbeschraenkt), Spenge, Germany
Page 1 of 2
FEB 2 4 2010
| 510(k) Number: | K093748 |
|---|---|
| ---------------- | --------- |
Date:
510(k) Summary
November 23, 2009
DD Bio Z, DD Bio Z-transpa
Porcelain powder for clinical use
K072569 Metoxit CAM blanks
(21 CFR 872.6660, Product Code EIH)
K081263 H.C. Starck Ceramics StarCeram K051462 DENTSPLY International Cercon Base
Submitter of 510(k) ﻪ ﺗ
Dental Direkt of Amerika UG (haftungsbeschraenkt) Pappelweg 6 32139 Spenge Germany
Contact Person
Gerhard de Boer (General Manager) Tel 0049 / 5225-8 6319-0 Fax: 0049 / 5225-8 6319-99
Establishment Registration Pending Number
Date Prepared
Common name
Trade Name of Device
Powder, Porcelain
Class II
Classification name
Classification
Predicate Devices
Device Description and Intended Use
Dental Blanks made of DD Bio Z or DD Bio Z-transpa are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or handoperated copy-milling machines. machines with outstanding biocompatibility and high resistance against tension and pressure.
Dental Blanks made from DD Bio Z or DD Bio Ztranspa are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
1
Page 2 of 2
510(k) Number: K093748
Date:
Clinical and Non-Clinical Dental Direkt of Amerika UG (haftungsbeschraenkt) Testing did not 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 standards: ANSI ADA Specifications No. 69:1999 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 characteristics The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They are made from the same materials and have the same intended use.
Substantial Equivalence Dental Direkt of Amerika UG (haftungsbeschraenkt) Conclusion believes that DD Bio Z and DD Bio Z-transpa 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gerhard de Boer FEB 2 4 2010 General Manager Dental Direkt of Amerika UG (haftungsbeschraenkt) Pappelweg 6 32139 Spenge GERMANY
Re: K093748
Trade/Device Name: DD Bio Z, DD Bio Z-transpa Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 29, 2010 Received: February 3, 2010
Dear Mr. de Boer:
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.
3
Page 2- Mr. de Boer
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ph for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 1093748
Device Name: DD Bio Z, DD Bio Z-transpa
Indications for Use:
:
Dental Blanks made from DD Bio Z or DD Bio Z-transpa are indicated for crowns, multiunit bridges and inlay bridges. Applications include both anterior and posterior ridges.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz ms for Dr. K.P. Muly
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K093748
510(k) Premarket Notification