(89 days)
Zirconium-oxide blanks for permanent and removable dental prosthetics.
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).
This document is a 510(k) Pre-market Notification for a dental material, Ceramill® Zolid HT+ white, and focuses on demonstrating its substantial equivalence to a predicate device, Ceramill® ZI. It is not an AI/ML device, so many of the requested criteria regarding AI model performance or human reader studies are not applicable.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (zirconium-oxide blanks for dental prosthetics), acceptance criteria are typically defined by recognized international standards for ceramic dental materials. The study's goal is to show that the new device meets or is equivalent to the predicate device in key performance characteristics relevant to these standards.
| Characteristic | Acceptance Criteria (Predicate Ceramill® ZI) | Reported Device Performance (Ceramill® Zolid HT+ white) | Device Comparison / Acceptance Met |
|---|---|---|---|
| Material Composition | |||
| ZrO2 + HfO2 + Y2O3 | ≥ 99.0% | ≥ 99.0% | Same |
| Y2O3 | 4.5 - 5.6% | 6.7 - 7.2% | Similar (variance, but no new safety/effectiveness concerns) |
| HfO2 | ≤ 5% | ≤ 5% | Same |
| Al2O3 | ≤ 0.5% | ≤ 0.5% | Same |
| Other oxides | ≤ 1% | ≤ 1% | Same |
| Physical Properties | |||
| Sintering Temperature/Duration | 1450°C — 2 hours | 1450°C — 2 hours | Same (Both meet ISO 6872:2015) |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 69.0 ± 1.5% | 60.0 ± 1.5% | Different (lower opacity/higher translucency, but equivalent high bending strength) |
| Flexural Bending Strength (3-point) (MPa) | 1200 ± 150 (≥8 Weibull modulus) | 1100 ± 150 (≥8 Weibull modulus) | Similar (Both meet ISO 6872:2015 minimum average of 800 MPa; 100 MPa difference not significant; Type II, Class 5) |
| Flexural Bending Strength (4-point) (MPa) | 1000 ± 150 (≥8 Weibull modulus) | 1000 ± 150 (≥8 Weibull modulus) | Same |
| E-module (GPa) | ≥ 200 | ≥ 200 | Same |
| Thermal Expansion Coefficient (CTE) (10⁻⁶/K) (25-500°C) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical Solubility (µg/cm²) | < 100 | < 100 | Same |
| Vickers Hardness (HV10) | 1300 ± 200 | 1300 ± 200 | Same |
| Final Density (g/cm³) | ≥ 6.07 | ≥ 6.05 | Similar (0.02 difference not significant; 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): 24.50 - 28.00%; V (H): 23.50 - 28.00%; H < 1 | V (L/W): 22.00 – 24.00%; V (H): 21.00 – 24.00%; H < 1 | Similar (difference in shrinkage, but no influence on performance/safety; a process parameter for dental lab) |
| Radioactivity (Bq/g) | ≤ 1.0 | ≤ 1.0 | Same |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench testing of physical and chemical properties of a dental ceramic. It does not involve a "test set" in the context of clinical data or AI model evaluation. Sample sizes would refer to the number of specimens tested for each physical or chemical property (e.g., number of bars for flexural strength, number of samples for density). These specific sample quantities are not provided in the summary, but the testing was conducted according to recognized international standards (ISO, EN), which would specify appropriate sample sizes for such tests.
The data provenance is from bench testing carried out by Amann Girrbach AG (Austrian manufacturer submitting through a Dutch consultant). This is prospective testing of the device properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving interpretation by experts or establishment of ground truth for a diagnostic test. The "ground truth" for the material properties is established by the direct measurement of its physical and chemical characteristics using standardized methods.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring human adjudication for diagnostic outcomes.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
Not applicable. This is a material science study, not a diagnostic imaging study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this device is a physical dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is derived from standardized physical and chemical measurements of the material's properties according to ISO and EN standards. These measurements establish the intrinsic characteristics of the ceramic material.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: debora.engel@amanngirrbach.com
Office number: +49 (7231) 957-260
2. Submission Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague
2514AP
The Netherlands
Contact: Rachel Paul
Title: Senior Consultant, QA&RA
Email: project.management@emergogroup.com
Cellphone number: 00 33 6 89 83 16 09
Office number: +31 (0) 70 345 8570
Direct number: +31 (0) 70 850 8249
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,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,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 secondpremolar). | further than the secondpremolar). | |||
| RegulationNumber | 872.6660 | 872.6660 | Same | Contraindications | -Insufficient tooth-structure availability-Insufficient preparationresults-Insufficient oral hygiene-More than two connectedbridge units in theposterior region, morethan three connectedintermediate units in theanterior region-Known incompatibilitieswith respect to thecomponents-Heavily discolored hardtooth structure-Provisional insertion | -Insufficient tooth-structure availability-Insufficient preparationresults-Insufficient oral hygiene-More than two connectedbridge units in theposterior region, morethan three connectedintermediate units in theanterior region-Known incompatibilitieswith respect to thecomponents-Heavily discolored hardtooth structure-Provisional insertion | Same |
| Regulation Name | Porcelain powder forclinical use | Porcelain powder forclinical use | Same | Chemicalcomposition (wt%) | -Zirconia :ZrO2 + HfO2 + Y2O3 ≥ 99.0-Composition:Y2O3: 6.7 - 7.2HfO2: ≤ 5Al2O3: ≤ 0.5Others oxides: ≤ 1 | -Zirconia :ZrO2 + HfO2 + Y2O3 ≥ 99.0-Composition:Y2O3: 4.5 - 5.6HfO2: ≤ 5Al2O3: ≤ 0.5Others oxides: ≤ 1 | Similar – variance inmaterial does notintroduce any new safetyor effectivenessconcerns. Both materialsmeet ZrO2 + HfO2 + Y2O3 ≥99.0. |
| Indications for Use | Zirconium-oxide blanks forpermanent and removabledental prosthetics. | Zirconium-oxide blanks forpermanent and removabledental prosthetics. | Same | Shapes | Disks (« U »-shape orround-shape) | Disks (round), blocks(rectangular) | Similar – predicate isavailable in disks andblocks whereas Ceramill®Zolid HT+ white isavailable only in diskshape as the block shapeused for manual copymilling is no more sold. |
| Conditions of Use | -Anatomically reducedcrown and bridge frames inthe anterior and posteriortooth range, andmonolithic (fullyanatomical) crowns andbridges;-Anatomically reduced fourto multi-unit bridge frameswith a maximum of threeconnected intermediateunits in the anterior regionand a maximum of twoconnected intermediatelinks in the posteriorregion;-Monolithic four to multi-unit bridges with amaximum of threeconnected intermediateunits in the anterior regionand a maximum of twoconnected intermediatelinks in the posteriorregion;-Cantilever frames andbridges with a maximum ofone bridge unit (maximum | -Anatomically reducedcrown and bridge frames inthe anterior and posteriortooth range, andmonolithic (fullyanatomical) crowns andbridges;-Anatomically reduced fourto multi-unit bridge frameswith a maximum of threeconnected intermediateunits in the anterior regionand a maximum of twoconnected intermediatelinks in the posteriorregion;-Monolithic four to multi-unit bridges with amaximum of threeconnected intermediateunits in the anterior regionand a maximum of twoconnected intermediatelinks in the posteriorregion;-Cantilever frames andbridges with a maximum ofone bridge unit (maximum | Same |
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| Manufacturer | Amann Girrbach AG | Amann Girrbach America,Inc. | Device Comparison |
|---|---|---|---|
| Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | |
| Dimensions (mm) | -Various-« U »-shape: 90 x 72, ineight different heights (10,12, 14, 16, 18, 20, 25, 30).-Round-shape: 98 mm ofdiameter, in eight differentheights (10, 12, 14, 16, 18,20, 25, 30). | -Various-Three sizes: tworectangular (40 x 20 x 16and 65 x 30 x 20) and oneround (98 x 20). | Similar — both areavailable in various sizes |
| Supplied sterile | No | No | Same |
| Single use | Yes | Yes | Same |
| SinteringTemperature andDuration | 1450°C — 2 hours | 1450°C — 2 hours | Same – Both meet ISO6872:2015 |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 60.0 ± 1.5% | 69.0 ± 1.5% | Different - Ceramill® ZolidHT+ white has a highertranslucency (loweropacity) compared topredicate but anequivalent high bendingstrength. |
| Flexural bendingstrength (at 3-point) (MPa) (andWeibull modulus) | 1100 ± 150 (≥8) | 1200 ± 150 (≥8) | Similar - Both meet ISO6872:2015 minimumaverage of 800 MPa. Adifference of 100 MPa isnot significant. Both areclassified dental ceramicsof Type II, Class 5according to ISO6872:2015. |
| Flexural bendingstrength (at 4-point) (MPa) (and | 1000 ± 150 (≥8) | 1000 ± 150 (≥8) | Same |
| Manufacturer | Amann Girrbach AG | Amann Girrbach America,Inc. | Device Comparison |
| Trade Name | Ceramill® Zolid HT+ white | Ceramill® ZI (Predicate) | |
| Weibul modulus) | |||
| E-module (GPa) | ≥ 200 | ≥ 200 | Same |
| Thermal expansioncoefficient (CTE)(25-500°C) (10⁻⁶/K) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical solubility(µg/cm²) | < 100 | < 100 | Same |
| Vickers hardness(HV10) | 1300 ± 200 | 1300 ± 200 | Same |
| Final Density(g/cm³) | ≥ 6.05 | ≥ 6.07 | Similar – a difference of0.02 is not significant.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%V (H): 21.00 – 24.00%H < 1 | V (L/W): 24.50 - 28.00%V (H): 23.50 - 28.00%H < 1 | Similar - the difference inshrinkage has no influenceon the performance andsafety of the blanks.Shrinkage is only a processparameter for the dentallab. |
| Radioactivity(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.
§ 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.