Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material properties and manufacturing process of a dental prosthetic blank, with no mention of AI or ML.

Therapeutic

No.
This device is a material used for manufacturing dental prosthetics, which are considered medical devices but not therapeutic in themselves; they are restorative.

Diagnostic

No

Explanation: The device is a material (zirconium-oxide blanks) used for fabricating dental prosthetics, which is a treatment rather than a diagnostic tool. Its function is to create physical restorations, not to identify or characterize diseases or conditions.

SaMD (Software as a Medical Device)

No

The device is a physical material (zirconium-oxide blanks) used for dental prosthetics, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for creating permanent and removable dental prosthetics. This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a material (zirconium-oxide blanks) used to fabricate dental prosthetics. It is processed and then placed in the patient's mouth.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
User and Setting: The intended user is a dental technician, and the setting is likely a dental lab or clinic, focused on fabrication and restoration.

IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Zirconium-oxide blanks for permanent and removable dental prosthetics.

Product codes (comma separated list FDA assigned to the subject device)

EIH

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dental

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental technician

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)

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:

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.
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.

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.

K063511

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

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.

Summary

0

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 PRAStaff@fda.hhs.gov

"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 (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

4

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.

--------------	-------------------	---------------------------------	-------------------

Table 5A – Comparison of Characteristics

5

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

6

7

| 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, in
eight different heights (10,
12, 14, 16, 18, 20, 25, 30).
-Round-shape: 98 mm of
diameter, in eight different
heights (10, 12, 14, 16, 18,
20, 25, 30). | -Various
-Three sizes: two
rectangular (40 x 20 x 16
and 65 x 30 x 20) and one
round (98 x 20). | Similar — both are
available in various sizes |
| Supplied sterile | No | No | Same |
| Single use | Yes | Yes | Same |
| Sintering
Temperature and
Duration | 1450°C — 2 hours | 1450°C — 2 hours | Same – Both meet ISO
6872:2015 |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 60.0 ± 1.5% | 69.0 ± 1.5% | Different - Ceramill® Zolid
HT+ white has a higher
translucency (lower
opacity) compared to
predicate but an
equivalent high bending
strength. |
| Flexural bending
strength (at 3-
point) (MPa) (and
Weibull modulus) | 1100 ± 150 (≥8) | 1200 ± 150 (≥8) | Similar - Both meet ISO
6872:2015 minimum
average of 800 MPa. A
difference of 100 MPa is
not significant. Both are
classified dental ceramics
of Type II, Class 5
according to ISO
6872:2015. |
| Flexural bending
strength (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 expansion
coefficient (CTE)
(25-500°C) (10⁻⁶/K) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical solubility
(µg/cm²) |