(55 days)
Not Found
No
The summary describes a dental blank material for CAD/CAM milling, with no mention of AI or ML in its function or processing.
No
Explanation: This device is a semi-finished product for manufacturing dental restorations like crowns and bridges, which are prosthetic devices, not therapeutic devices.
No
Explanation: The device is a dental blank for fabricating crowns and bridges, not for diagnosing medical conditions. Its function is to be milled into a restoration, which is a treatment, not a diagnostic step.
No
The device description clearly states it is a "semi finished product made of yttrium 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:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, etc.) for placement in the mouth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a semi-finished product made of zirconium dioxide for milling dental frameworks. This material is used to build the physical structure of the restoration, not to perform a test on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a material used in the manufacturing of a medical device (dental restoration), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Med TransColour Red is a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213. StarCeram® Z-Med TransColour Red has the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change is the addition of a new color additive.
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)
No performance data was required or provided. Biocompatibility and cvtotoxicity testing was performed which showed that all versions of the product comply with ISO 10993-1 and ISO 10993-5. Biocompatibility testing was performed under Design Controls to show that the modified version of the product continued to comply with the recognized consensus standards.
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.
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
510(k) SUMMARY
JUN 0 5 2014
H.C. Starck Ceramics GmbH StarCeram®
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 (978) 824-2541 Facsimile:
Date Prepared: March 21, 2014
Name of Device and Name/Address of 510(k) Owner
StarCeram® Z-Med StarCeram® Z-Al-Med HD StarCeram® Z-Al-Med HD Colour StarCeram® Z-Al-Med-HD Translucent StarCeram® Z-Med TransColour StarCeram® Z-Med TransColour Red
H.C. Starck Ceramics GmbH Lorenz-Hutschenreuther-Str. 81 95100 Selb, Germany
Common or Usual Name
Powder, Porcelain
Classification Name
21 C.F.R. 872.6660
Predicate Devices
StarCeram Z-Med and Z-Al-Med HD (K133213)
1
Intended Use / Indications for Use
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Technological Characteristics
Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Med TransColour Red is a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213. StarCeram® Z-Med TransColour Red has the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change is the addition of a new color additive.
Performance Data
No performance data was required or provided. Biocompatibility and cvtotoxicity testing was performed which showed that all versions of the product comply with ISO 10993-1 and ISO 10993-5. Biocompatibility testing was performed under Design Controls to show that the modified version of the product continued to comply with the recognized consensus standards.
Substantial Equivalence
H.C. Starck's StarCeram® Z-Med Transcolour Red is a modification to the StarCeram® products cleared in K133213. StarCeram® Z-Med TransColour Red has the same intended use and indications for use, principles of operation, and similar technological characteristics as the previously cleared predicate device. StarCeram® Dental Blanks are indicated for crowns, multiunit bridges, inlay bridges and all-ceramic restoration. Applications include anterior and posterior bridges. This is the exact indications for use statement cleared for StarCeram® in K133213. Thus, StarCeram® Z-Med TransColour Red has the same intended use and may be substantially equivalent.
StarCeram® Z-Med TransColour Red has the same technological characteristics as the predicate device. All of the devices are vttrium stabilized pre-sintered zirconium dioxide to be used in dental restorations. The StarCeram® products cleared in K133213 and StarCeram® Z-Med TransColour Red are all dental blanks which are fabricated to the desired shape by the user based on the specific needs of the patient. The only
2
difference between StarCeram® Z-Med TransColour Red and the StarCeram® products cleared in K133213 is the addition of a color additive.
This difference has been addressed by performing biocompatibility testing which shows that the new version of the product was found to be biocompatible. Therefore, the differences do not affect the safety or effectiveness of the products.
77
3
Indications for Use Statement
K140924 510(k) Number (if known):___
Device Name: StarCeram®
Indications for Use:
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Prescription Use __ X (Part 21 C.F.R. 801 Subpart D) Subpart C)
AND/OR
Over-The-Counter Use_ (21 C.F.R. 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Greens 2014.06.05 15:23:07
Page 1 of 1
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contral Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2014
H.C. Starck Ceramics GmbH C/O Ms. Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Incorporated 5 Timber Lane North Reading, MA 01864
Re: K140924
Trade/Device Name: StarCeram® Z-Med TransColour Red Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 8, 2014 Received: May 9, 2014
Dear Ms. O'Connell:
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 for use stated in the enotices of the enactment date of the Medical Device Amendments, or to commerce prof to May 20, 1970, the accordance with the provisions of the Federal Food, Drug, de nees mat have been roomstiled trequire approval of a premarket approval application (PMA). and Costiere rice (rice) that to not required to the general controls provisions of the Act. The 1 ou may, merceive, manel the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and actives, good mananatianing praction as a maginate information related to contract liability adultieration. Ticase note: ODNey develop must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classince (500 abore) into stire) in the stime major regulations affecting your device can be It may of Subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of Peacharts concerning your device in the Federal Register.
5
Page 2 - Ms. O Connell
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
Mary S. Runner -S
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
6
Indications for Use Statement
K140924 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
StarCeram® Device Name:
Indications for Use:
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) Subpart C)
AND/OR :
Over-The-Counter Use_ (21 C.F.R. 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Greenss 2014.06.05 15:28:00
Page 1 of 1