Ceramill Zolid HT+ white

K171876 · Amann Girrbach AG · EIH · Sep 20, 2017 · Dental

Device Facts

• Record ID: K171876
• Device Name: Ceramill Zolid HT+ white
• Applicant: Amann Girrbach AG
• Product Code: EIH · Dental
• Decision Date: Sep 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Zirconium-oxide blanks for permanent and removable dental prosthetics.

Device Story

Ceramill Zolid HT+ white is an all-ceramic dental material composed of Yttria-Stabilized Zirconium Oxide (YSZ). Provided as U-shaped or round disks, the material is intended for CAD/CAM fabrication of copings, substrates, and monolithic restorations for permanent and removable dental prosthetics. Used in dental laboratories, the device is milled by a dental technician and subsequently fired in an oven to harden the ZrO2. The final restoration is placed by a clinician. The device provides a high-strength, biocompatible ceramic core for dental restorations, offering improved translucency compared to the predicate while maintaining equivalent mechanical properties.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical property verification (flexural strength, E-module, hardness, CTE) and biocompatibility testing per ISO 10993 standards.

Technological Characteristics

Material: Yttria-Stabilized Zirconium Oxide (YSZ). Form factor: U-shape or round disks. Sintering: 1450°C for 2 hours. Standards: ISO 6872:2015 (Dentistry-Ceramic Materials), ISO 13356:2015 (Y-TZP implants), ISO 7405:2008, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-18:2005, EN 1641:2009. Non-sterile, single-use.

Indications for Use

Indicated for permanent and removable dental prosthetics, including anatomically reduced crown and bridge frames (anterior/posterior), monolithic crowns and bridges, and cantilever frames/bridges. Contraindicated for patients with insufficient tooth structure, insufficient preparation results, insufficient oral hygiene, known component incompatibilities, heavily discolored tooth structure, or provisional insertion.

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 (K063511)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 20,2017

Amann Girrbach AG % Rachel Paul Senior Consultant, OA & RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP THE NETHERLANDS

Re: K171876

Trade/Device Name: Ceramill Zolid HT+ white Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: July 17, 2017 Received: July 20, 2017

Dear Rachel 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.

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

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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 devicerelated 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runner

for Tina Kiang, Ph.D. Acting 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) K171876

Device Name Ceramill Zolid HT+ white

Indications for Use (Describe) Zirconium-oxide blanks for permanent and removable dental prosthetics.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary (Special 510(k))

## Ceramill® Zolid HT+ white

## K171876

#### 1. Submission Sponsor

Amann Girrbach AG

Herrschaftswiesen 1

6842 Koblach

AUSTRIA

Contact Name: Debora Engel

Title: Regulatory Affairs Manager

Email: [e-mail]

Office number: [phone]

#### 2. Submission Correspondent

Emergo Europe Consulting

Prinsessegracht 20

The Hague

2514AP

The Netherlands

Contact: Rachel Paul

Title: Senior Consultant, QA&RA

Email: [e-mail]

Cellphone number: 00 33 6 89 83 16 09

Office number: [phone]

Direct number: [phone]

#### 3. Date Prepared

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26th June 2017

## 4. Device Identification

| Trade/Proprietary Name: | Ceramill® Zolid HT+ white |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Porcelain powder for clinical use |
| Classification Name: | Porcelain Powder |
| Regulation Number: | 872.6660 |
| Product Code: | EIH |
| Device Class: | Class II |
| Classification Panel: | Dental |

### 5. Legally Marketed Predicate Device(s)

K063511, Ceramill® ZI, Amann Girrbach America

#### 6. Indication for Use Statement

Zirconium-oxide blanks for permanent and removable dental prosthetics.

#### 7. Device Description

Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-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. 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).

### 8. Substantial Equivalence Discussion

The following table compares the modified device Ceramill® Zolid HT+ white to the unmodified predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides detailed information regarding the basis for the determination of substantial equivalence, and supports that the subject device, as modified, does not raise any new issues of safety or effectiveness than the predicate device.

| Manufacturer | Amann Girrbach AG | Amann Girrbach America,<br>Inc. | Device Comparison |
|--------------|-------------------|---------------------------------|-------------------|
|--------------|-------------------|---------------------------------|-------------------|

### Table 5A – Comparison of Characteristics

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| Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | Manufacturer | Amann Girrbach AG | Amann Girrbach America,<br>Inc. | Device Comparison | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | N/A | Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | | |
| Product Code | EIH | EIH | | further than the second<br>premolar). | further than the second<br>premolar). | | |
| Regulation<br>Number | 872.6660 | 872.6660 | Same | Contraindications | -Insufficient tooth-<br>structure availability<br>-Insufficient preparation<br>results<br>-Insufficient oral hygiene<br>-More than two connected<br>bridge units in the<br>posterior region, more<br>than three connected<br>intermediate units in the<br>anterior region<br>-Known incompatibilities<br>with respect to the<br>components<br>-Heavily discolored hard<br>tooth structure<br>-Provisional insertion | -Insufficient tooth-<br>structure availability<br>-Insufficient preparation<br>results<br>-Insufficient oral hygiene<br>-More than two connected<br>bridge units in the<br>posterior region, more<br>than three connected<br>intermediate units in the<br>anterior region<br>-Known incompatibilities<br>with respect to the<br>components<br>-Heavily discolored hard<br>tooth structure<br>-Provisional insertion | Same |
| Regulation Name | Porcelain powder for<br>clinical use | Porcelain powder for<br>clinical use | Same | Chemical<br>composition (wt%) | -Zirconia :<br>ZrO2 + HfO2 + Y2O3 ≥ 99.0<br>-Composition:<br>Y2O3: 6.7 - 7.2<br>HfO2: ≤ 5<br>Al2O3: ≤ 0.5<br>Others oxides: ≤ 1 | -Zirconia :<br>ZrO2 + HfO2 + Y2O3 ≥ 99.0<br>-Composition:<br>Y2O3: 4.5 - 5.6<br>HfO2: ≤ 5<br>Al2O3: ≤ 0.5<br>Others oxides: ≤ 1 | Similar – variance in<br>material does not<br>introduce any new safety<br>or effectiveness<br>concerns. Both materials<br>meet ZrO2 + HfO2 + Y2O3 ≥<br>99.0. |
| Indications for Use | Zirconium-oxide blanks for<br>permanent and removable<br>dental prosthetics. | Zirconium-oxide blanks for<br>permanent and removable<br>dental prosthetics. | Same | Shapes | Disks (« U »-shape or<br>round-shape) | Disks (round), blocks<br>(rectangular) | Similar – predicate is<br>available in disks and<br>blocks whereas Ceramill®<br>Zolid HT+ white is<br>available only in disk<br>shape as the block shape<br>used for manual copy<br>milling is no more sold. |
| Conditions of Use | -Anatomically reduced<br>crown and bridge frames in<br>the anterior and posterior<br>tooth range, and<br>monolithic (fully<br>anatomical) crowns and<br>bridges;<br>-Anatomically reduced four<br>to multi-unit bridge frames<br>with a maximum of three<br>connected intermediate<br>units in the anterior region<br>and a maximum of two<br>connected intermediate<br>links in the posterior<br>region;<br>-Monolithic four to multi-<br>unit bridges with a<br>maximum of three<br>connected intermediate<br>units in the anterior region<br>and a maximum of two<br>connected intermediate<br>links in the posterior<br>region;<br>-Cantilever frames and<br>bridges with a maximum of<br>one bridge unit (maximum | -Anatomically reduced<br>crown and bridge frames in<br>the anterior and posterior<br>tooth range, and<br>monolithic (fully<br>anatomical) crowns and<br>bridges;<br>-Anatomically reduced four<br>to multi-unit bridge frames<br>with a maximum of three<br>connected intermediate<br>units in the anterior region<br>and a maximum of two<br>connected intermediate<br>links in the posterior<br>region;<br>-Monolithic four to multi-<br>unit bridges with a<br>maximum of three<br>connected intermediate<br>units in the anterior region<br>and a maximum of two<br>connected intermediate<br>links in the posterior<br>region;<br>-Cantilever frames and<br>bridges with a maximum of<br>one bridge unit (maximum | Same | | | | |

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| Manufacturer | Amann Girrbach AG | Amann Girrbach America,<br>Inc. | Device Comparison |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | |
| | | | |
| Dimensions (mm) | -Various<br>-« U »-shape: 90 x 72, in<br>eight different heights (10,<br>12, 14, 16, 18, 20, 25, 30).<br>-Round-shape: 98 mm of<br>diameter, in eight different<br>heights (10, 12, 14, 16, 18,<br>20, 25, 30). | -Various<br>-Three sizes: two<br>rectangular (40 x 20 x 16<br>and 65 x 30 x 20) and one<br>round (98 x 20). | Similar — both are<br>available in various sizes |
| Supplied sterile | No | No | Same |
| Single use | Yes | Yes | Same |
| Sintering<br>Temperature and<br>Duration | 1450°C — 2 hours | 1450°C — 2 hours | Same – Both meet ISO<br>6872:2015 |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 60.0 ± 1.5% | 69.0 ± 1.5% | Different - Ceramill® Zolid<br>HT+ white has a higher<br>translucency (lower<br>opacity) compared to<br>predicate but an<br>equivalent high bending<br>strength. |
| Flexural bending<br>strength (at 3-<br>point) (MPa) (and<br>Weibull modulus) | 1100 ± 150 (≥8) | 1200 ± 150 (≥8) | Similar - Both meet ISO<br>6872:2015 minimum<br>average of 800 MPa. A<br>difference of 100 MPa is<br>not significant. Both are<br>classified dental ceramics<br>of Type II, Class 5<br>according to ISO<br>6872:2015. |
| Flexural bending<br>strength (at 4-<br>point) (MPa) (and | 1000 ± 150 (≥8) | 1000 ± 150 (≥8) | Same |
| Manufacturer | Amann Girrbach AG | Amann Girrbach America,<br>Inc. | Device Comparison |
| Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | |
| Weibul modulus) | | | |
| E-module (GPa) | ≥ 200 | ≥ 200 | Same |
| Thermal expansion<br>coefficient (CTE)<br>(25-500°C) (10⁻⁶/K) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical solubility<br>(µg/cm²) | < 100 | < 100 | Same |
| Vickers hardness<br>(HV10) | 1300 ± 200 | 1300 ± 200 | Same |
| Final Density<br>(g/cm³) | ≥ 6.05 | ≥ 6.07 | Similar – a difference of<br>0.02 is not significant.<br>Both meet ISO 6872:2015. |
| Porosity (%) | 0 (no open porosity) | 0 (no open porosity) | Same |
| Grain Size (μm) | ≤ 0.6 | ≤ 0.6 | Same |
| Shrinkage | V (L/W): 22.00 – 24.00%<br>V (H): 21.00 – 24.00%<br>H < 1 | V (L/W): 24.50 - 28.00%<br>V (H): 23.50 - 28.00%<br>H < 1 | Similar - the difference in<br>shrinkage has no influence<br>on the performance and<br>safety of the blanks.<br>Shrinkage is only a process<br>parameter for the dental<br>lab. |
| Radioactivity<br>(Bq/g) | ≤ 1.0 | ≤ 1.0 | Same |

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### 9. Non-Clinical Performance Data

Bench tests confirm that product specifications of the modified device Ceramill® Zolid HT+ white are met. These are equivalent to those of the predicate device. The biocompatibility testing confirm that the modified device Ceramill® Zolid HT+ white is as biocompatible as the predicate. The testing results support that the new zirconia material does not affectiveness of the device as compared to the zirconia material of the unmodified device. Verification testing of the modified device Ceramill® Zolid HT+ white, in accordance with design controls, demonstrated the device meets user needs. Verification testing was performed to the following:

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- ISO 6872:2015 - Dentistry - Ceramic Materials
- . ISO 13356:2015 - Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- ISO 7405:2008 - Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
- EN 1641:2009 - Dentistry. Medical devices for dentistry. Materials
- ISO 10993-1:2009 – 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: Tests for in vitro cytotoxicity
- . ISO 10993-18:2005 - Biological evaluation of medical devices -- Part 18: Chemical characterization of materials

The device passed all testing and is determined to be substantially equivalent to the unmodified Ceramill® ZI device.

### 10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the intended use is the same as the predicate device. These types of devices, including the predicate devices, have been used successfully for many years. 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 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, but can be demonstrated to be substantially equivalent to the predicate device, and does not raise additional questions regarding its safety and effectiveness.

As such, the nonclinical tests conducted that demonstrate that the Ceramil® Zolid HT+ white device is as safe and effective as the unmodified Ceramill® ZI, and is determined to be substantially equivalent to predicate device.