(198 days)
No
The summary describes dental blanks made of zirconium dioxide for use in CAD/CAM systems, with no mention of AI or ML in the device description, intended use, or performance studies. The changes described are related to color qualities.
No
The device is a semi-finished dental material used for fabricating dental restorations (crowns, bridges), not a device that itself provides a therapeutic effect.
No
Explanation: The device is described as dental blanks used for the milled production of crowns and bridge frameworks, which are restorative dental products, not diagnostic tools.
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 used for dental restorations. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these are "Dental Blanks made from StarCeram® products" used for "milled production of crowns and bridge framework." These are materials used to create dental restorations that are placed in the body, not used to test samples from the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes. The performance studies focus on biocompatibility, which is relevant for materials implanted in the body, not for diagnostic tests.
Therefore, this device falls under the category of a dental material or prosthetic component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges and allceramic restoration. Applications include both anterior and posterior bridges.
Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.
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-Smile and StarCeram® Z-Nature are a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213 and K140924. StarCeram® Z-Smile and StarCeram® Z-Nature have the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change between the cleared products and the new products is the addition of new color qualities.
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)
Non-clinical Testing: Biocompatibility and cytotoxicity 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.
Clinical Testing: No clinical testing was performed.
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.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
H.C. Starck Ceramics GmbH c/o Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K143656
Trade/Device Name: StarCeram® Z-Nature, StarCeram® Z-Smile Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: June 10, 2015 Received: June 11, 2015
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 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
Page 2 - Ms. Maureen 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/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 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 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
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Indications for Use
510(k) Number (if known) K143656
Device Name StarCeram® Z-Nature StarCeram® Z-Smile
Indications for Use (Describe)
Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges and allceramic restoration. Applications include both anterior and posterior bridges.
Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K143656
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 (978) 207-1245 Phone: Facsimile: (978) 824-2541
Date Prepared: July 6, 2015
Name of Device and Name/Address of 510(k) Owner
StarCeram® Z-Nature StarCeram® Z-Smile
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 Porcelain powder for clinical use
Predicate Devices Primary Predicate StarCeram® products cleared in K133213
Reference Predicates StarCeram® Z-Med TransColour Red (K140924) DD cubeX2 (K150196)
4
Intended Use / Indications for Use
Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, multi-unit bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.
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-Smile and StarCeram® Z-Nature are a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213 and K140924. StarCeram® Z-Smile and StarCeram® Z-Nature have the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change between the cleared products and the new products is the addition of new color qualities.
Non-clinical Testing
Biocompatibility and cytotoxicity 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.
Clinical Testing
No clinical testing was performed.
| Product
Name | StarCeram®
Z-Nature and
Z-Smile | 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 | DD cubeX2 and
accessories |
| ----------------- | --------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------- | ------------------------------ |
|---|
Substantial Equivalence
5
| 510(k) Number | K143656 | K133213 | K140924 | K150196 |
|---|---|---|---|---|
| Product Code | EIH | EIH | EIH | EIH |
| Product Description | 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 machines. | 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 machines. | 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 machines. | DD cubeX2 is a semi-finished dental blank made of yttrium stabilized pre-sintered zirconium dioxide, which has a super high translucency. The ceramics is of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-178). The DD cubeX2 dental blanks are designed for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or hand-operated copy milling machines. |
| Material | Yttrium stabilized zirconium dioxide | Yttrium stabilized zirconium dioxide | Yttrium stabilized zirconium dioxide | Yttrium stabilized zirconium dioxide |
| Availability | Various colors, translucencies and thicknesses | Various colors, translucencies and thicknesses | Various colors, translucencies and thicknesses | Various colors, translucencies and thicknesses |
| Flexural Strength | Z-Smile >500 | |||
| Z-Nature 1,000 +/- 200 | 1,000 +/- 200 | 1,000 +/- 200 | >720 |
H.C. Starck's StarCeram® Z-Smile and StarCeram® Z-Nature are modifications to the StarCeram® products cleared in K133213 and K140924. StarCeram® Z-Nature has the same intended use and indications for use,
6
principles of operation, and similar technological characteristics as the previously cleared predicate devices. StarCeram® Dental Blanks are indicated for crowns, multi-unit 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 and K140924. Thus, StarCeram® Z-Nature has the same intended use and may be substantially equivalent.
StarCeram® Z-Smile is also substantially equivalent to the DD cubeX2 cleared in K150196. StarCeram® Z-Smile has the same intended use also allowing a maximum of 3 bridges to be constructed using the product. The flexural strength of StarCeram Z-Smile is slightly lower than the predicate, but exactly as required by DIN EN ISO 6872 for Class 5 dental ceramics (>500MPa). Therefore, STARCERAM Z-Smile is substantially equivalent to the DD cubeX2 cleared in K150196.
StarCeram® Z-Smile and StarCeram® Z-Nature have the same technological characteristics as the predicate devices. All of the devices are yttrium stabilized pre-sintered zirconium dioxide to be used in dental restorations. The StarCeram® products cleared in K133213 and K140924, and StarCeram® Z-Smile and StarCeram® Z-Nature are all dental blanks which are fabricated to the desired shape by the user based on the specific needs of the patient.