Ceramill Zolid FX

K152383 · Emergo Europe Consulting · EIH · Sep 21, 2015 · Dental

Device Facts

• Record ID: K152383
• Device Name: Ceramill Zolid FX
• Applicant: Emergo Europe Consulting
• Product Code: EIH · Dental
• Decision Date: Sep 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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).

Device Story

Ceramill Zolid FX is an all-ceramic dental material composed of Yttria-Stabilized Zirconium Oxide (YSZ) provided as U-shaped disks. Dental technicians use CNC milling machines (e.g., Ceramill Motion) to fabricate copings and substrates for fixed all-ceramic restorations from these blanks. Following milling, the material undergoes oven firing to harden the ZrO2. The device is used in dental laboratories by technicians to produce permanent and removable prosthetics, such as crowns and three-unit bridges. The final restoration is placed by a dentist. The material provides a durable, biocompatible core for dental prosthetics, benefiting patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including flexural strength (4-point bending), Weibull modulus, Vickers hardness, density, thermal expansion, open porosity, modulus of elasticity, radioactivity, and biocompatibility (cytotoxicity, chemical analysis) per ISO 10993 and ISO 6872 standards.

Technological Characteristics

Material: Yttria-Stabilized Zirconium Oxide (ZrO2 + HfO2 + Y2O3 ≥ 99.0%). Form factor: U-shaped disks. Sintering: 1450°C for 2 hours. Standards: ISO 6872:2008, ISO 13356, ISO 9396, ANSI/ADA No. 69:2010. Biocompatibility: ISO 10993-1, -5, -12, -18, and ISO 7405. Non-sterile, single-use.

Indications for Use

Indicated for patients requiring permanent or removable dental prosthetic restorations, including crowns and up to 3-unit bridges in the anterior and posterior regions.

Regulatory Classification

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.

Predicate Devices

• Ceramill ZI blanks (K063511)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

#### 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

for

# "Ceramill Zolid FX"

## 1. Submission Sponsor

Amann Girrbach AG Herrschaftswiesen 1 6842 Koblach Austria Phone: [phone] Fax: [phone] Contact: Debora Engel, Regulatory Affairs Manager

## 2. SubmissionCorrespondent

Emergo Europe Consulting Prinsessegracht 20 2514APThe Hague The Netherlands Cell Phone: [phone] Office Phone: [phone] Direct: [phone] Fax: [phone] Contact: Rachel Paul, Senior Consultant, RA & QA Email: [e-mail]

## 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.

{4}------------------------------------------------

#### 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<br>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<br>Use | Porcelain Powder for Clinical<br>Use | Same |
| Indications for Use | Zirconium-oxide blanks for<br>permanent and removable<br>dental prosthetics. | Amann Girrbach America, Inc.<br>Ceramill ZI blanks are<br>used in the<br>manufacture of dental<br>prosthetics. | Same.<br>Ceramill ZI blanks are<br>used in the manufacture<br>of dental prosthetics<br>permanent and<br>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<br>and up to 3-unit bridge frames<br>in the anterior and posterior<br>tooth range, as well as<br>monolithic (fully anatomical)<br>crowns and 3-unit bridges<br>- anatomically reduced<br>bridge frames with a<br>maximum of one<br>connected intermediate units<br>in the anterior and in the<br>posterior region monolithic<br>bridges with a maximum of<br>one connected intermediate<br>units in the anterior and in<br>the posterior region. | - anatomically reduced<br>crown and bridge frames in<br>the anterior and posterior<br>tooth range<br>- bridges frames with a<br>maximum of 3 connected<br>intermediate units in the<br>anterior and 2 connected<br>intermediate links in the<br>posterior region, and a<br>maximum anatomical length<br>of 50mm cantilever bridges<br>with a maximum of 1 bridge<br>pontic (maximum 1 free-end<br>pontic and no further than<br>the second premolar). | Similar with minor<br>variance: exclusion of too<br>long (more than one<br>connected intermediate<br>units) bridge frames for<br>the Ceramill Zolid FX<br>blanks. |
| Material(wt%) | Zirconia<br>ZrO2 + HfO2 + Y2O3 ≥ 99.0%<br>Composition:<br>Y2O3<br>9.15-9.55<br>Al2O3<br>< 0.06<br>HfO2<br>< 3<br>SiO2<br><0.02<br>Fe2O3<br><0.01 | Zirconia<br>ZrO2 + HfO2 + Y2O3 > 99.0%<br>Composition:<br>Y2O3<br>4.5 - 5.6<br>Al2O3<br>< 0.5<br>HfO2<br>< 5<br>SiO2 and Fe2O3<br>< 0.5 | Similar. All meet ISO 13356 |
| Shapes | Disks (U-shape) | Disks, blocks | Similar. Ceramill Zolid FX only<br>available in U-shape. |
| Dimensions | various<br>6 sizes (approx. 90 x 70mm) of<br>different height (12, 14, 16,<br>18, 20 and 25mm) | various<br>3 sizes: 2 rectangular (40 x 20<br>×<br>16mm, 65 x 30 x 20mm) and 1<br>round (98 x 20 mm) | Similar. Ceramill Zolid FX only<br>available in U-shape. |
| Supplied Sterile | No | No | Same |
| Single Use | Yes | Yes | Same |
| Sintering<br>Temperature | 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,<br>no impact on properties |
| Flexural Bending<br>Strength | >500MPa | ≥1200MPa | Difference. Too long (more than<br>1 connected intermediate units)<br>bridge frames are excluded from<br>Ceramill Zolid FX blanks<br>indications. Both meet ISO<br>13356 |
| Weibull Modulus | 9.54 | 10.63 | Similar. Both meet ISO 13356 |
| Hardness(Vicker's<br>Hardness) | 1300 ± 200 HV10 | 1300 ± 200 HV10 | Same |
| Coefficient of<br>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<br>(raw material) | <0.2Bq/g | <0.2Bq/g | Same |

{5}------------------------------------------------

{6}------------------------------------------------

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<br>(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

{7}------------------------------------------------

- 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.