(28 days)
Not Found
No
The summary describes a dental material (zirconia blanks) and its intended use in traditional CAD/CAM milling processes, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a material (zirconium oxide blanks) used for manufacturing dental prosthetic restorations, not a therapeutic device itself. Its purpose is to replace missing teeth or parts of teeth, which is a restorative rather than a therapeutic function in the medical sense of treating a disease or disorder.
No
This device is a dental material (zirconium oxide blanks) used for manufacturing prosthetic restorations, not for diagnosing conditions.
No
The device description clearly states it is a physical material (zirconium oxide blanks) used for manufacturing dental restorations. It is 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 manufacturing permanent and removable prosthetic restorations (like crowns and bridges) for dental applications. This is a structural and restorative purpose, not for diagnosing a disease or condition.
- Device Description: The device is a material (zirconium oxide blanks) used to create dental prosthetics. It's a component in the manufacturing process of a medical device (the dental restoration), not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device falls under the category of a dental material used for fabrication, which is a different regulatory classification.
N/A
Intended Use / Indications for Use
"Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations (e.g. crowns and three-unit bridges to the molar region). The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
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 was performed in order to validate the design against the Company's specified design requirements for physical and chemical properties, as well as flexural strength, and to assure conformance with the consensus design standard ISO 6872:2008. "Ceramill Zolid FX" is classified as Type II Class 5 esthetic dental ceramic.
The material complies with ANSI ADA Specification No. 69:2010, Dental Ceramic.
The "Ceramill Zolid FX" passed all testing stated above as shown by the acceptable results obtained.
The "Ceramill Zolid FX" complies with the applicable voluntary standards for demonstrating biocompatibility:
- ISO 10993-1: 2010, Biological Evaluation of Medical Devices --- Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-5: 2009, Biological Evaluation of Medical Devices --- Part 5: Test for In Vitro Cytotoxicity
- ISO 10993-12: 2012, Biological Evaluation of Medical Devices Part 12: Samples preparation and reference materials
- ISO 10993-18:2005, Biological Evaluation of Medical Devices Part 18: Chemical characterization of the materials
- ISO 7405:2008, Second Edition, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
Test results show that the extract of the test material caused no toxicological/biological cell damage or growth inhibition. The material is considered as non-cytotoxic and the extracts of the material did not contain organic or inorganic detectable substances.
The "Ceramill Zolid FX" complies with the applicable voluntary standard for risk management, ISO 14971:2007, Medical devices - Application of risk management to medical devices. The risk management activities verified that risks have been eliminated or reduced to acceptable levels from a benefit/risk assessment.
The "Ceramill Zolid FX" meets all the requirements for overall design and biocompatibility, and performance testing confirms that the output meets the design inputs and specifications.
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.
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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 caduceus, which is 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. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21,2015
Amann Girrbach AG c/o Ms. Rachel Paul Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP THE NETHERLANDS
Re: K152383
Trade/Device Name: Ceramill Zolid FX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 24, 2015 Received: August 24, 2015
Dear Ms. Paul:
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.
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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 (OS) 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.
Susan Runno DDS, MA
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
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Indications for Use
510(k) Number (if known)
Device Name
"Ceramill Zolid FX"
Indications for Use (Describe)
"Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
for
"Ceramill Zolid FX"
1. Submission Sponsor
Amann Girrbach AG Herrschaftswiesen 1 6842 Koblach Austria Phone: +49 (7231) 957-260 Fax: +49 (7231) 957-249 Contact: Debora Engel, Regulatory Affairs Manager
2. SubmissionCorrespondent
Emergo Europe Consulting Prinsessegracht 20 2514APThe Hague The Netherlands Cell Phone: +33 (0)6 89 83 16 09 Office Phone: +31 (0) 70 345 85 70 Direct: +31 (0) 70 850 82 49 Fax: +31 (0) 70 346 72 99 Contact: Rachel Paul, Senior Consultant, RA & QA Email: project.management@emergogroup.com
3. Date Prepared
11 September 2015
4. DeviceIdentification
| Trade/Proprietary Name: | "Ceramill Zolid FX" |
|---|---|
| Common/Usual Name: | Porcelain powder for clinical use |
| Classification Name: | Powder, Porcelain |
| Classification Regulation: | 21 CFR Part 872.6660 |
| Product Code: | EIH |
| Device Class: | Class II |
| Classification Panel: | Dental |
5. Legally Marketed Predicate Device(s)
Amann Girrbach America, Inc. Ceramill Zl blanks 510(K) Number K063511.
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6. Device Description
Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations (e.g. crowns and three-unit bridges to the molar region). The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
7. Indication for Use Statement
Zirconium-oxide blanks for permanent and removable dental prosthetics.
8. Substantial Equivalence Discussion
The following table compares the "Ceramill Zolid FX" to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Amann Girrbach AG | Amann Girrbach America, Inc. | Significant Differences |
|---|---|---|---|
| Trade Name | Ceramill Zolid | ||
| FX | Ceramill ZI | ||
| 510(k) Number | K152383 | K063511 | N/A |
| Product Code | EIH | EIH | Same |
| Regulation Number | 21 CFR Part 872.6660 | 21 CFR Part 872.6660 | Same |
| Regulation Name | Porcelain Powder for Clinical | ||
| Use | Porcelain Powder for Clinical | ||
| Use | Same | ||
| Indications for Use | Zirconium-oxide blanks for | ||
| permanent and removable | |||
| dental prosthetics. | Amann Girrbach America, Inc. | ||
| Ceramill ZI blanks are | |||
| used in the | |||
| manufacture of dental | |||
| prosthetics. | Same. | ||
| Ceramill ZI blanks are | |||
| used in the manufacture | |||
| of dental prosthetics | |||
| permanent and | |||
| removable. |
| Table 5A – Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | Amann Girrbach AG | Amann Girrbach America, Inc. | Significant Differences |
| Trade Name | Ceramill Zolid FX | Ceramill ZI | |
| Applications | - anatomically reduced crown | ||
| and up to 3-unit bridge frames | |||
| in the anterior and posterior | |||
| tooth range, as well as | |||
| monolithic (fully anatomical) | |||
| crowns and 3-unit bridges |
- anatomically reduced
bridge frames with a
maximum of one
connected intermediate units
in the anterior and in the
posterior region monolithic
bridges with a maximum of
one connected intermediate
units in the anterior and in
the posterior region. | - anatomically reduced
crown and bridge frames in
the anterior and posterior
tooth range - bridges frames with a
maximum of 3 connected
intermediate units in the
anterior and 2 connected
intermediate links in the
posterior region, and a
maximum anatomical length
of 50mm cantilever bridges
with a maximum of 1 bridge
pontic (maximum 1 free-end
pontic and no further than
the second premolar). | Similar with minor
variance: exclusion of too
long (more than one
connected intermediate
units) bridge frames for
the Ceramill Zolid FX
blanks. |
| Material(wt%) | Zirconia
ZrO2 + HfO2 + Y2O3 ≥ 99.0%
Composition:
Y2O3
9.15-9.55
Al2O3
99.0%
Composition:
Y2O3
4.5 - 5.6
Al2O3
500MPa | ≥1200MPa | Difference. Too long (more than
1 connected intermediate units)
bridge frames are excluded from
Ceramill Zolid FX blanks
indications. Both meet ISO
13356 |
| Weibull Modulus | 9.54 | 10.63 | Similar. Both meet ISO 13356 |
| Hardness(Vicker's
Hardness) | 1300 ± 200 HV10 | 1300 ± 200 HV10 | Same |
| Coefficient of
Thermal | 10.1 ± 0.5 *10-6/K | 10.4 ± 0.5 *10-6/K | Similar. Both meet ISO 9396 |
| Modulus of Elasticity | >200GPa | >200GPa | Same |
| Radioactivity
(raw material) |