priti multidisc ZrO2 High Translucent

K161025 · Pritidenta GmbH · EIH · Feb 3, 2017 · Dental

Device Facts

• Record ID: K161025
• Device Name: priti multidisc ZrO2 High Translucent
• Applicant: Pritidenta GmbH
• Product Code: EIH · Dental
• Decision Date: Feb 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.

Device Story

Device consists of pre-sintered Yttria fully stabilized zirconium oxide (5Y-FSZ) blanks; supplied as 98.5mm diameter discs in various thicknesses and VITA shades. Used in dental laboratories and offices by dentists and dental technicians. Blanks are processed via CNC milling machines to fabricate dental restorations (crowns, bridges, inlays, onlays, veneers). Final restoration is achieved after milling and subsequent sintering. Device provides high-translucency aesthetic dental prostheses. No software or electronic components involved; device is non-sterile.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 6872:2015, including determination of radioactivity (gamma spectroscopy), coefficient of thermal expansion, chemical solubility, flexural strength, and fracture resistance. Biocompatibility evaluated per ISO 10993-1 based on material equivalence to predicate devices.

Technological Characteristics

Material: Yttria fully stabilized zirconia (5Y-FSZ). Form factor: 98.5mm diameter discs, 10-25mm thickness. Standards: ISO 6872:2015 (Type II, Class 4). Manufacturing: Pre-sintered ceramic blank for CNC milling. Sterilization: Non-sterile. No software or electronic components.

Indications for Use

Indicated for dental patients requiring partial or single anterior/lateral crowns, bridges up to 3 units, inlays, onlays, or veneers.

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

• Luxer Shaded Zirconia (K140070)

Reference Devices

• DD cube X2 (K150196)
• priti®multidisc ZrO2Translucent (K100250)
• priti®multidisc ZrO2 Opaque (K100250)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized human figure with outstretched arms, symbolizing care and protection. The logo is simple, clean, and easily recognizable.

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

April 7, 2017

Mrs. Magdalena Geigenberger CEO Pritidenta Inc. 1170 Howell Mill Road, Suite 300 Atlanta, Georgia 30318

Re: K161025 Trade/Device Name: Priti Multidisc Zro2 High Translucent Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 22, 2016 Received: December 27, 2016

Dear Magdalena Geigenberger:

This letter corrects our substantially equivalent letter of February 3, 2017.

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 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

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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 Industry and Consumer Education 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" (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 Industry and Consumer Education 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 DDS, MA

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) K161025

Device Name priti® multidisc Zr02 High Translucent

### Indications for Use (Describe)

priti®multidisc Zr02 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----|
| Prescription Use (Part 21 CFR 801 Subpart D) | Yes |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Image /page/3/Picture/0 description: The image shows the logo for "pritidenta". The logo features a stylized graphic of three curved lines above the text. The word "pritidenta" is written in a modern, sans-serif font, with two small pink squares above the "i"s. Below "pritidenta" is the tagline "PIONEERING DENTISTRY" in smaller, lighter font.

# Section 5.0: 510(k) Summary

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Image /page/4/Picture/0 description: The image shows the logo for Pritidenta, a dentistry company. The logo features a stylized graphic of three hills or curves above the company name. The name "pritidenta" is written in a modern sans-serif font, with two small pink squares above the "i"s. Below the name is the tagline "PIONEERING DENTISTRY" in smaller, all-caps letters.

# 510(k) Summary

#### l. SUBMITTER

Mrs. Anke Riemer QA/RA, Finance, HR, Legal pritidenta GmbH Meisenweg 37 70771 Leinfelden-Echterdingen Germany Phone: [phone] e-mail: [e-mail]

as our submitter of the answers to the deficiency list for K 161025/S001 and all further information unless other information will come up.

Switchboard: +49 (0)711.320.656.0 +49 (0)711.320.656.99 Fax: Contact at pritidenta GmbH: Mrs. Anke Riemer

# OFFICIAL CORRESPONDENT

Mrs. Magdalena Geigenberger CEO pritidenta Inc. 1170 Howell Mill Road, Suite 300 Atlanta, GA 30318, USA Phone: [phone] e-mail: [e-mail]

Feb 02, 2017 Date Prepared:

#### DEVICE II.

Device Name: Common/Usual Name: Classification Name: Product Code: Class:

priti®multidisc ZrO2 High Translucent Porcelain Powder for Clinical Use Powder, Porcelain ElH ll

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Image /page/5/Picture/0 description: The image shows the logo for "pritidenta", a dentistry company. The logo features a stylized mountain range above the company name. Below the name is the text "PIONEERING DENTISTRY" and the words "PREDICATE DEVICES".

Predicate Device Luxer Shaded Zirconia, K140070

This predicate device has not been subject to a recall.

# Reference Predicate Device

DD cube X2, K150196

This reference predicate device has not been subject to a recall.

Reference device, own 510(k) submission priti®multidisc ZrO2Translucent and priti®multidisc ZrO2 Opaque, K100250

This reference predicate device has not been subject to a recall.

### IV. DEVICE DESCRIPTION

The priti multidisc ZrOs High Translucent blanks are made of Yttria fully stabilized zirconia (5Y-FSZ Fully Stabilized Zirconia), whereby the increased translucency is due to the higher stabilization of the zirconia base powder with yttrium oxide (Y2O3).

The priti®multidisc ZrO₂ High Translucent blanks are provided as round discs with a diameter of 98.5mm, and varying thicknesses along with 16 VITA color shades, and multicolor versions.

We hereby specifically state each shade and color available for the subject device:

| VITA shades | Heights |
|-------------|----------------------------|
| | (10,12,14,16,18,20,25)[mm] |
| A1 | All |
| A2 | All |
| A3 | All |
| A3,5 | All |
| A4 | All |
| B1 | All |
| B2 | All |
| B3 | All |
| B4 | All |
| C1 | All |
| C2 | All |
| C3 | All |
| C4 | All |
| D2 | All |

K 161025 pritidenta 510(k) for priti®multidisc ZrOz High Translucent Rev. 006, date 2017-02-02 CONFIDENTIAL Page 5-3

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| | | pritidenta® |
|--|--|-------------|
| | | |
| | | |

| PIONEERING DENTISTRY | |
|-------------------------------------------|-------------|
| D3 | All |
| D4 | All |
| White | All |
| multicolor: | |
| A light (covers range between A1, A2, A3) | 14,18,20,25 |
| B light (includes B1, B2) | 14,18,20,25 |
| C light (includes C1, C2) | 14,18,20,25 |
| D light (includes D2, D3, D4) | 14,18,20,25 |
| A dark (includes A3,5; A4) | 14,18,20,25 |
| B dark (includes B3, B4) | 14,18,20,25 |
| C dark (includes C3, C4) | 14,18,20,25 |

### V. INDICATIONS FOR USE

priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE AND REFERENCE DEVICES

The pritismultidisc ZrO2 High Translucent, the primary predicate device, Luxer Shaded Zirconia, the reference predicate device, DD cubeX', as well as pritidenta's own reference device priti multidisc ZrO2Translucent and pritismultidisc ZrO2 Opaque are supplied in a presintered state as discs/blanks of varying thicknesses and are suitable for milling to produce crowns or bridges.

All blank materials are ceramics based upon Yttria stabilized zirconium oxide (ZrO₂/HfO₂/Y₂O₃). The priti®multidisc ZrO₂ High Translucent and Luxer Shaded Zirconia Predicate Device are fabricated from TOSOH TZ-Series white, yellow, pink and gray powders or equivalent and include Fe-O3, Er-O3 and Co3O2 to provide the color shading, thereby establishing substantial equivalence for the chemical composition of the subject device.

Change of classes due to change in ISO standard:

The priti®multidisc ZrO2 High Translucent and the predicate devices have been characterized per ISO 6872:2015 Dentistry - Ceramic materials and have met the requirements for their respective categories per ISO 6872. The priti® multidisc ZrO> High Translucent device is a Type II, Class 4 material per ISO 6872:2015 Dentistry – Ceramic materials. The primary predicate device, Luxer Shaded Zirconia, materials are Type II, Class 5 per ISO 6872:2015 Dentistry - Ceramic materials. The reference predicate device, DD

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Image /page/7/Picture/0 description: The image shows the logo for Pritidenta, a dentistry company. The logo features a stylized graphic of three hills or mountains above the company name. The name "pritidenta" is written in a modern, sans-serif font, with two small pink squares above the "i"s. Below the name, the words "PIONEERING DENTISTRY" are written in a smaller font.

, is also a Type II, Class 4 material per ISO 6872:2008 Dentistry - Ceramic materials as is the priti®multidisc ZrO2 High Translucent device.

Own reference device priti® multidisc ZrO2 Translucent and priti® multidisc ZrO2 Opaque are Type II, class 5 devices per ISO 6872:2015 Dentistry - Ceramic materials.

#### VII. SUBSTANTIAL EQUIVALENCE DISCUSSION

The following table compares the priti® multidisc ZrO2 High Translucent device to the Primary Predicate Device Luxer Shaded Zirconia, DD cubeX2 Reference Predicate and Reference Device priti®multidisc ZrO2 Translucent and Opaque with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

Table 12-1: Substantial Equivalence Comparison Table – priti® multidisc ZrO2 High Translucent, Predicate Device Luxer Shaded Zirconia, DD cubeX Reference Predicate and Reference Device priti®multidisc ZrO₂ Translucent and Opaque

| Characte<br>ristics | priti®multidisc<br>ZrO2 High<br>Translucent | Luxer Shaded Zirconia<br>K140070<br>Primary Predicate | DD cubeX²<br>K150196<br>Reference Predicate | priti®multidisc<br>ZrO2 Translucent<br>and Opaque<br>Reference device |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | This Submission | K140070 | K150196 | K100250 |
| Trade<br>name | priti®multidisc ZrO2<br>High Translucent | Luxer Shaded Zirconia | DD cubeX² | priti®multidisc ZrO2<br>Translucent |
| Indica-<br>tions for<br>Use | priti®multidisc ZrO2<br>High Translucent<br>are pre-sintered<br>zirconium oxide<br>blanks for use in<br>CNC milling<br>machines to<br>fabricate partial<br>and single anterior<br>and lateral crowns,<br>bridges up to three<br>units, inlays,<br>onlays, and<br>veneers for<br>restoration<br>purposes only. | Luxer Shaded Zirconia<br>blanks are intended for<br>use with CAD/CAM<br>technology to produce all<br>ceramic dental<br>restorations (full contour<br>crowns and bridges) as<br>prescribed by a dentist. | Dental blanks made<br>from DD cubeX² are<br>indicated for crowns,<br>multi-unit bridges (up<br>to a maximum of three<br>elements) and inlay<br>bridges. Applications<br>include both, anterior<br>and posterior bridges. | priti®multidisc ZrO2<br>Translucent /<br>priti®multidisc ZrO2<br>Opaque are pre-sintered<br>zirconium oxide blanks for<br>use in CNC milling<br>machines to fabricate<br>crowns, bridges, inlays,<br>and onlays for restoration<br>purposes only. |
| Classifica<br>tion Code | 21 CFR 872.6660<br>Product Code: EIH | 21 CFR 872.6660<br>Product Code: EIH | 21 CFR 872.6660<br>Product Code: EIH | 21 CFR 872.6660<br>Product Code: EIH |

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Image /page/8/Picture/0 description: The image shows the logo for Pritidenta, a dentistry company. The logo features a stylized mountain range above the company name. The word "pritidenta" is written in a modern sans-serif font, with two small pink squares above the "i"s. Below the company name, the words "Pioneering Dentistry" are written in a smaller font.

| SUBSTANTIAL EQUIVALENCE BASED UPON INTENDED USE | | | | |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------|----------------------------------------------------------------------------|
| User | Dental technicians<br>and dentists | Dental technicians and<br>dentists | Dental technicians and<br>dentists | Dental technicians and<br>dentists |
| User<br>Environ-<br>ment | Dental laboratories,<br>dental offices | Dental laboratories,<br>dental offices | Dental laboratories,<br>dental offices | Dental laboratories and<br>dental offices |
| Multi-unit<br>bridges | Up to three units | No limitation | Up to three units | No limitations |
| SUBSTANTIAL EQUIVALENCE BASED UPON TECNOLOGICAL<br>CHRACTERISTICS | | | | |
| Blank<br>Configu-<br>ration | Discs | Discs | Discs | Discs |
| Thick-<br>nesses | 10 to 25 mm | 12 mm to 20 mm | 12 mm to 20 mm | 10 to 25 mm |
| Accesso-<br>ries | None | None | Yes, coloring liquids | None |
| Colors | White,<br>VITA Shades A to<br>D<br>Multicolor<br>(Combination of<br>VITA shades) | White,<br>VITA Shades A to D<br>Multicolor | White | White,<br>VITA Shades A to D<br>Multicolor (Combination<br>of VITA shades) |

#### VIII. PERFORMANCE DATA

## Biocompatibility Testing

Biological testing requirements were evaluated based upon FDA Draft Guidance on the Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (April 23, 2013). As stated in the FDA guidance document referencing Appendix C - Biocompatibility Flow Chart, biocompatibility requirements were met on the basis that the material used in the priti® multidisc ZrO₂ High Translucent device is the same as in the predicate device with the same manufacturing process, same chemical composition, same body contact for both the subject device and the predicate.

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Image /page/9/Picture/0 description: The image shows the logo for Pritidenta, a pioneering dentistry company. The logo features a stylized mountain range above the company name, with the "i" in "pritidenta" dotted with pink squares. Below the company name, the words "Pioneering Dentistry" are written in a smaller font. The words "Performance Testing" are written in bold black font below the company name.

- Performance testing was conducted in accordance with ISO 6872:2008 Dentistry -Ceramic materials. The pritismultidisc ZrO2 High Translucent device is classified as a Type II, Class 4 device and met the standard requirements per ISO 6872:2015. We also provided a comparison between ISO 6872:2008 and ISO 6872:2015, effects of changes to materials properties.
General type of testing performed:

- Determination of radioactivity by gamma spectroscopy -
- -Determination of coefficient of thermal expansion
- Determination of chemical solubility -
- Determination of flexural strength -
- -Determination of fracture resistance
- Freedom from extraneous materials test was conducted via literature based risk estimation.

### Sterilization

Due to the status of a semi-finished product as a kind of blank that will be finalized at customers labs, these blanks are shipped not sterile.

## IX. CONCLUSIONS

The performance testing conducted demonstrates that the pritismultidisc ZrQz High Translucent device is substantially equivalent to the predicate devices.

In comparison to the predicate, using ISO standard 6872 the data from that testing concludes that both materials are fundamentally the same. They both have the same fundamental technology and physical properties (coefficient of thermal expansion, biocompatibility, solubility).

Based on the comparative data, priti® multidisc ZrO2High Translucent device is essentially the same as currently marketed devices for the same indication, with similar physical and chemical properties, which supports our claim for substantial equivalence.

The priti®multidisc ZrO2 High Translucent shows no differences in technological characteristics compared to the predicate devices.

The indications for use of this pritidenta's submission (K161025) are covered by indications for use of pritidenta's previous submission of the own reference devices K100250.

That demonstrates that the pritismultidisc ZrO2 High Translucent device is substantially equivalent to the own reference devices.