"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).

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).

AI/ML Overview

The document provided describes the submission of a medical device (Ceramill Zolid FX) for FDA clearance, demonstrating its substantial equivalence to a predicate device (Ceramill ZI blanks). The information provided focuses on non-clinical performance data and does not contain details about studies involving human readers or AI assistance. Therefore, some of the requested information, particularly related to human reader studies, AI assistance, and large-scale data sets, is not applicable or available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Ceramill Zolid FX" are based on conformance to applicable national and international standards, primarily ANSI ADA Specification No. 69:2010 (Dental Ceramic) and ISO 6872:2008 (Dentistry – Ceramic Materials), as well as internal specifications.

Test / Performance Metric	Acceptance Criteria (Standard / Predicate)	Reported Device Performance (Ceramill Zolid FX)
Material Composition (wt%)	Zirconia (ZrO2 + HfO2 + Y2O3 > 99.0%) (Predicate)	Zirconia (ZrO2 + HfO2 + Y2O3 ≥ 99.0%)
Y2O3	4.5 - 5.6 (Predicate)	9.15 - 9.55
Al2O3	< 0.5 (Predicate)	< 0.06
HfO2	< 5 (Predicate)	< 3
SiO2 and Fe2O3	< 0.5 (Predicate)	SiO2 < 0.02, Fe2O3 < 0.01
Physical/Mechanical Properties
Bulk Density	≥6.07 g/cm³ (Predicate) / Meets ISO 6872	≥6.05 g/cm³ / Meets ISO 6872
Open Porosity	0% (Predicate) / Meets ISO 6872	0% / Meets ISO 6872
Grain Size	<0.6 µm (Predicate)	0.8 µm
Flexural Bending Strength	≥1200 MPa (Predicate) / Meets ISO 13356 & ISO 6872	>500 MPa / Meets ISO 13356 & ISO 6872 (Note: Lower than predicate, but still meets standard for its limited indications)
Weibull Modulus	10.63 (Predicate) / Meets ISO 13356 & ISO 6872	9.54 / Meets ISO 13356 & ISO 6872
Hardness (Vicker's Hardness)	1300 ± 200 HV10 (Predicate) / Meets internal specifications	1300 ± 200 HV10 / Meets internal specifications
Coefficient of Thermal Expansion	10.4 ± 0.5 *10-6/K (Predicate) / Meets ISO 9396 & ISO 6872	10.1 ± 0.5 10-6/K / Meets ISO 9396 & ISO 6872*
Modulus of Elasticity	>200 GPa (Predicate) / Meets internal specifications	>200 GPa / Meets internal specifications
Radioactivity (raw material)	<0.2 Bq/g (Predicate) / Meets ISO 6872	<0.2 Bq/g / Meets ISO 6872
Biocompatibility	Non-toxicological/biological cell damages and growth inhibition (ISO 10993)	Caused no toxicological/biological cell damages and growth inhibition / Extracts did not contain organic or inorganic detectable substances / Non-cytotoxic
Chemical Analysis	No organic or inorganic detectable substances (ISO 10993)	Extracts did not contain organic or inorganic detectable substances

Note: The differences in flexural strength and Y2O3 content are acknowledged, but the device is still considered substantially equivalent due to its modified indications (e.g., exclusion of longer bridges for Ceramill Zolid FX) and conformance to relevant ISO standards for its intended use classification (Type II, Class 5 aesthetic dental ceramic).

2. Sample size used for the test set and the data provenance

The document refers to "non-clinical testing" without specifying a 'test set' in the context of clinical trials or retrospective/prospective data collection from patients. The testing involved material properties, not patient data. The provenance of the samples (e.g., raw material batches) is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a material science and engineering study for dental ceramic properties, not a study requiring expert clinical read-outs or ground truth establishment by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is detailed as it's not a clinical study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document describes a traditional medical device submission for a dental ceramic material, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. No algorithm or AI device is being discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established international and national standards for dental ceramics (e.g., ISO 6872:2008, ANSI ADA Specification No. 69:2010, ISO 13356, ISO 9396, ISO 10993 standards for biocompatibility) and internal specifications. These standards define the acceptable range or minimum thresholds for various physical, chemical, and biological properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI context. The document refers to testing of material batches.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI context. The material's properties are measured directly against established standards.

Summary

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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)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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 ZolidFX	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 ClinicalUse	Porcelain Powder for ClinicalUse	Same
Indications for Use	Zirconium-oxide blanks forpermanent and removabledental prosthetics.	Amann Girrbach America, Inc.Ceramill ZI blanks areused in themanufacture of dentalprosthetics.	Same.Ceramill ZI blanks areused in the manufactureof dental prostheticspermanent andremovable.

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 crownand up to 3-unit bridge framesin the anterior and posteriortooth range, as well asmonolithic (fully anatomical)crowns and 3-unit bridges- anatomically reducedbridge frames with amaximum of oneconnected intermediate unitsin the anterior and in theposterior region monolithicbridges with a maximum ofone connected intermediateunits in the anterior and inthe posterior region.	- anatomically reducedcrown and bridge frames inthe anterior and posteriortooth range- bridges frames with amaximum of 3 connectedintermediate units in theanterior and 2 connectedintermediate links in theposterior region, and amaximum anatomical lengthof 50mm cantilever bridgeswith a maximum of 1 bridgepontic (maximum 1 free-endpontic and no further thanthe second premolar).	Similar with minorvariance: exclusion of toolong (more than oneconnected intermediateunits) bridge frames forthe Ceramill Zolid FXblanks.
Material(wt%)	ZirconiaZrO2 + HfO2 + Y2O3 ≥ 99.0%Composition:Y2O39.15-9.55Al2O3< 0.06HfO2< 3SiO2<0.02Fe2O3<0.01	ZirconiaZrO2 + HfO2 + Y2O3 > 99.0%Composition:Y2O34.5 - 5.6Al2O3< 0.5HfO2< 5SiO2 and Fe2O3< 0.5	Similar. All meet ISO 13356
Shapes	Disks (U-shape)	Disks, blocks	Similar. Ceramill Zolid FX onlyavailable in U-shape.
Dimensions	various6 sizes (approx. 90 x 70mm) ofdifferent height (12, 14, 16,18, 20 and 25mm)	various3 sizes: 2 rectangular (40 x 20×16mm, 65 x 30 x 20mm) and 1round (98 x 20 mm)	Similar. Ceramill Zolid FX onlyavailable in U-shape.
Supplied Sterile	No	No	Same
Single Use	Yes	Yes	Same
SinteringTemperature	1450°C - 2 hours	1450°C - 2 hours	Same
Bulk Density	≥6.05 g/cm³	≥6.07 g/cm³	Similar. Both meet ISO 6872
Open Porosity	0%	0%	Same
Grain Size	0.8 µm	<0.6 µm	Similar. Comparable values,no impact on properties
Flexural BendingStrength	>500MPa	≥1200MPa	Difference. Too long (more than1 connected intermediate units)bridge frames are excluded fromCeramill Zolid FX blanksindications. Both meet ISO13356
Weibull Modulus	9.54	10.63	Similar. Both meet ISO 13356
Hardness(Vicker'sHardness)	1300 ± 200 HV10	1300 ± 200 HV10	Same
Coefficient ofThermal	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)	<0.2Bq/g	<0.2Bq/g	Same

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The "Ceramill Zolid FX" device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact safety or efficacy.

9. Non-Clinical Performance Data

Safety and performance of "Ceramill Zolid FX" was shown in accordance with applicable national and international standards. The material complies with ANSI ADA Specification No. 69:2010, Dental Ceramic.

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 disks can be fabricated into various prosthetic dental devices and the zirconia powder conforms to ISO 6872:2008, Dentistry – Ceramic Materials and BS EN 1641:2004, Dentistry, Medical Devices for Dentistry, Materials. The table below summarizes the results.

Test	Conformance to ISO 6872:2008
Flexural Strength(4-point bending test)	The results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Weibull Modulus	The results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Vickers Hardness	The results meeting the internal specifications requirements support a finding of substantial equivalence.
Final density	The results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Thermal Expansion Coefficient (CTE)	The CTE results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Open Porosity	The results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Modulus of Elasticity	The results meeting the internal specifications requirements support a finding of substantial equivalence.
Radioactivity	The results meeting the predefined criteria as specified in ISO 6872:2008 (E) support a finding of substantial equivalence.
Cytotoxicity	The results show that the extract of the test material caused no toxicological/biological cell damages and growth inhibition.
Chemical Analysis	The extracts of the material did not contain organic or inorganic detectable substances

Table 5B: Testing performed for the "Ceramill Zolid FX" 510(k) Submission

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

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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.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device (there have been little to no adverse events reported). The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The proposed device and the predicate have the same intended use. The technological characteristics are identical or similar.

It has been shown in this 510(k) submission that the difference between the "Ceramill Zolid FX" and the predicate devices do not raise any different questions regarding its safety and effectiveness. The "Ceramill Zolid FX", as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 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.