(297 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the priti®multidisc ZrO2 High Translucent device, based on the provided FDA 510(k) summary:
This document describes a 510(k) premarket notification for a dental ceramic material, priti®multidisc ZrO2 High Translucent. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. It is important to note that this document is for a material (zirconia blanks) used to fabricate dental restorations, not a diagnostic AI device. Therefore, many of the typical AI/ML study components (like expert ground truth, adjudication, MRMC studies, training/test sets for algorithms) are not applicable. The "acceptance criteria" here refer to meeting performance standards for the material itself.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the priti®multidisc ZrO2 High Translucent device are based on adherence to the ISO 6872:2015 "Dentistry - Ceramic materials" standard.
| Acceptance Criterion (ISO 6872:2015 Standard Requirements) | Reported Device Performance (priti®multidisc ZrO2 High Translucent) |
|---|---|
| Classification as Type II, Class 4 material (as per ISO 6872:2015) | Met (device classified as Type II, Class 4) |
| Radioactivity | Determined by gamma spectroscopy (met standard, implicitly) |
| Coefficient of Thermal Expansion | Determined (met standard, implicitly) |
| Chemical Solubility | Determined (met standard, implicitly) |
| Flexural Strength | Determined (met standard, implicitly) |
| Fracture Resistance | Determined (met standard, implicitly) |
| Freedom from extraneous materials | Conducted via literature-based risk estimation (met standard, implicitly) |
Note: The document states that the device "met the standard requirements per ISO 6872:2015" for its classification. Specific numerical values for the performance metrics (e.g., exact flexural strength in MPa) are not provided in this summary, but the general testing categories are listed.
2. Sample Size Used for the Test Set and Data Provenance
Given this is a material science study for dental blanks (not an AI device with a "test set" in the traditional sense):
- Sample Size: Not explicitly stated for each test. The testing was conducted on samples of priti®multidisc ZrO2 High Translucent blanks.
- Data Provenance: Not applicable in the context of patient data. The material itself is manufactured by pritidenta GmbH in Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a material testing study, not a study involving human interpretation of medical images or expert consensus for ground truth. The "ground truth" is established by physical and chemical properties measured against a recognized international standard (ISO 6872).
4. Adjudication Method
- Not Applicable. There is no adjudication method described as this is not a study requiring human readers or consensus on diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for a dental material product. This type of study is typically used for diagnostic or AI-assisted interpretation systems.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. This is a material; there is no algorithm or AI component involved.
7. Type of Ground Truth Used
- International Standard (ISO 6872:2015) and Laboratory Measurements. The ground truth is the established performance requirements outlined in the ISO standard for ceramic dental materials. The device's performance is measured in a laboratory setting to confirm it meets these predefined criteria.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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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 (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" (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 (800) 638-2041 or (301) 796-7100 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: +49.(0)711.320.656.23 e-mail: a.riemer@pritidenta.com
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: +1.404.409.8811 e-mail: m.geigenberger@pritidenta.com
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
| Characteristics | priti®multidiscZrO2 HighTranslucent | Luxer Shaded ZirconiaK140070Primary Predicate | DD cubeX²K150196Reference Predicate | priti®multidiscZrO2 Translucentand OpaqueReference device |
|---|---|---|---|---|
| 510(k)Number | This Submission | K140070 | K150196 | K100250 |
| Tradename | priti®multidisc ZrO2High Translucent | Luxer Shaded Zirconia | DD cubeX² | priti®multidisc ZrO2Translucent |
| Indica-tions forUse | priti®multidisc ZrO2High Translucentare pre-sinteredzirconium oxideblanks for use inCNC millingmachines tofabricate partialand single anteriorand lateral crowns,bridges up to threeunits, inlays,onlays, andveneers forrestorationpurposes only. | Luxer Shaded Zirconiablanks are intended foruse with CAD/CAMtechnology to produce allceramic dentalrestorations (full contourcrowns and bridges) asprescribed by a dentist. | Dental blanks madefrom DD cubeX² areindicated for crowns,multi-unit bridges (upto a maximum of threeelements) and inlaybridges. Applicationsinclude both, anteriorand posterior bridges. | priti®multidisc ZrO2Translucent /priti®multidisc ZrO2Opaque are pre-sinteredzirconium oxide blanks foruse in CNC millingmachines to fabricatecrowns, bridges, inlays,and onlays for restorationpurposes only. |
| Classification Code | 21 CFR 872.6660Product Code: EIH | 21 CFR 872.6660Product Code: EIH | 21 CFR 872.6660Product Code: EIH | 21 CFR 872.6660Product 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 techniciansand dentists | Dental technicians anddentists | Dental technicians anddentists | Dental technicians anddentists |
| UserEnviron-ment | Dental laboratories,dental offices | Dental laboratories,dental offices | Dental laboratories,dental offices | Dental laboratories anddental offices |
| Multi-unitbridges | Up to three units | No limitation | Up to three units | No limitations |
| SUBSTANTIAL EQUIVALENCE BASED UPON TECNOLOGICALCHRACTERISTICS | ||||
| BlankConfigu-ration | Discs | Discs | Discs | Discs |
| Thick-nesses | 10 to 25 mm | 12 mm to 20 mm | 12 mm to 20 mm | 10 to 25 mm |
| Accesso-ries | None | None | Yes, coloring liquids | None |
| Colors | White,VITA Shades A toDMulticolor(Combination ofVITA shades) | White,VITA Shades A to DMulticolor | White | White,VITA Shades A to DMulticolor (Combinationof 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.
§ 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.