(57 days)
Not Found
No
The device is a material (dental blanks) used in CAD/CAM systems or hand-operated milling machines, with no mention of AI/ML in its description or performance studies.
No
The device is described as "dental blanks" used for milling crowns and bridge frameworks, which are materials for restorative dental work, not therapeutic devices.
No
This device is described as a material for creating dental crowns and bridges, which are restorative prostheses, not tools for diagnosis.
No
The device description clearly states it 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, etc.) for placement in the mouth. This is a therapeutic/restorative purpose, not a diagnostic one.
- Device Description: The device is described as a dental material (semifinished product) for milling dental frameworks. This aligns with a dental prosthetic material, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a material used to create a physical restoration.
N/A
Intended Use / Indications for Use
Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling 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)
H.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determinc 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 6872:1995 + Amendment 1-1997
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.
K051462 DENTSPLY International Cercon Base, K062695 Sagemax Bioceramics, Inc. Sagemax Z-Blank, K072569 Metoxit CAM Blanks
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) Number:
Date: ________________________________________________________________________________________________________________________________________________________________________
Page 1 of 2
510(k) Summary
JUL -1 2008
2081263
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
H.C. Starck Ceramics GmbH & Co. KG Lorenz-Hutschenreuther-Str. 81 95100 Selb, GERMANY Tel: +49 92 878 07-0 / Fax: 92 878 07-477
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-463-0900 / Fax: 303-558-3833
Date Prepared
April 28, 2008
Trade Name of Device
StarCeram
Common Name of Device
Powder, Porcelain
Classification Name
Porcelain powder for clinical use
510(k) Classification
Class II
Predicate Devices
K051462 DENTSPLY International Cercon Base K062695 Sagemax Bioceramics, Inc. Sagemax Z-Blank K072569 Metoxit CAM Blanks
StarCeram 510(k) Page 16 of 113
1
| 510(k) Number: | |
|---|---|
| Date: |
Page 2 of 2
Device Description and Intended Use
Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.
Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Clinical and Non-Clinical Testing
II.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determinc 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 6872:1995 + Amendment 1-1997
Risk Management
This 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"
Substantial Equivalence
H.C. Starck Ceramics GmbH & Co. KG believes that StarCeram is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
JUL - 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
H.C. Starck Ceramics GmbH & Co. KG C/O Mr. Robert N. Clark President and Senior Consultant Medical Device Regulatory Advisors, Incorporated 13605 West 7th Avenue Golden, Colorado 80401-4604
Re: K081263
Trade/Device Name: StarCeram® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 28, 2008 Received: May 5, 2008
Dear Mr. Clark:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Clark
Enclosure
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
1208 1263 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: StarCeram _______________________________________________________________________________________________________________________________________________________
Indications for Use:
Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081263
Page 1 of 1
StarCeram 510(k) Page 14 of 113