PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

Device Description

The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.

All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.

The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.

AI/ML Overview

This document is a 510(k) Premarket Notification from Zirkonzahn srl to the FDA for their dental polymer blanks (discs) named ABRO 1, RESITON GINGIVA, PRIME, and THERAPON TRANSPA. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (UNION DENTAL S.A.'s IDODENTINE blanks) rather than proving the device meets specific performance acceptance criteria through a clinical study involving human patients or complex AI models.

Therefore, many of the requested criteria for describing a study proving the device meets acceptance criteria are not applicable to this type of regulatory submission for a medical device that is a material for dental restorations.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document refers to performance testing according to ISO 10477:2018 and states that "All tested samples meet the requirements of the standard and show similar values as the predicate device."

The comparison table on page 5 provides specific physical property values for both the new devices and the predicate, with acceptance being meeting standard requirements and showing similarity.

Criterion Type	Acceptance Criteria (Implied by reference to ISO standards)	Reported Device Performance (New Devices: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA)	Comparison to Predicate (IDODENTINE blanks)
Biocompatibility	Established in consideration of ISO 10993-1:2010 Part 1	Established	Same
Physical Properties	According to ISO 10477:2018 (meeting requirements)	According to ISO 10477:2018	Same (Predicate was ISO 10477:2004)
Flexural Strength	≥ 105 MPa (for new devices, as stated performance)	≥ 105 MPa	Similar (Predicate: 83-94 MPa)
Water Absorption	≤ 24 µg/mm³ (for new devices, as stated performance)	≤ 24 µg/mm³	Similar (Predicate: 22.3-25.8 µg/mm³)
Water Solubility	≤ 0.3 µg/mm³ (for new devices, as stated performance)	≤ 0.3 µg/mm³	Similar (Predicate: 0.7-0.9 µg/mm³)
Residual Monomer Content	Resiton Gingiva: 0.71 wt%, Therapon Transpa: < 5.0 wt%	Resiton Gingiva: 0.71 wt%, Therapon Transpa: < 5.0 wt%	Similar (Predicate: 1.4 %)
Shelf Life	10 years (specified for new devices)	10 years	Different (Predicate: None specified)

Note: The acceptance criteria for the new devices are primarily demonstrated by meeting the stated performance values or falling within ranges defined by the referenced ISO standards, and by showing equivalence or superiority to the predicate device's performance where applicable. The document explicitly states: "All tested samples meet the requirements of the standard and show similar values as the predicate device." and "most results indicate that the Zirkonzahn devices performed in a slight better way than the predicates. These differences are considered non-significant. All devices meet the requirements of the standards."

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes used for the non-clinical tests (e.g., how many specimens were tested for flexural strength, water absorption, etc.). It generally states "All tested samples."
Data Provenance: The tests were carried out by Zirkonzahn srl, which is an Italian company (Via An der Ahr 7 Gais, ITALY 39030). The data would be prospective, as it's generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the "ground truth" for material properties is established through adherence to standardized laboratory testing protocols (e.g., ISO 10477) using calibrated equipment, not through expert consensus or interpretation of complex data by human experts for a diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for laboratory testing of material properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This is a submission for dental polymer blanks, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This is a submission for dental polymer blanks, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is based on standardized laboratory test results for physical and chemical properties (e.g., ISO 10477 for physical properties, ISO 10993-1 for biocompatibility). These standards define the methods and criteria for evaluating the material.

8. The sample size for the training set:

This question is not applicable. This type of device (dental polymer blanks) does not involve a "training set" in the context of machine learning or deep learning.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

July 8, 2020

Zirkonzahn srl Sandra Leitner Regulatory Affairs Via An der Ahr 7 Gais. BZ 39030 Italy

Re: K200676

Trade/Device Name: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG. EBI. MOC Dated: April 7, 2020 Received: April 9, 2020

Dear Sandra Leitner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200676

Device Name

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

Indications for Use (Describe)

PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.

ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.

PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

Type of Use (Select one or both, as applicable)
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Research Use (Part of SER-001; Subject, Plasma)	Core Tissue Use (Part of SER-001; Subject, Core Tissue)
-----------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 05 510(k) Summary

510 (k) SUMMARY

510(k) number: K200676

APPLICANT

ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com

CONTACT PERSON

Sandra Leitner Regulatory Affairs ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 784 Fax: +39 0474 066 661 E-mail: sandra.leitner@zirkonzahn.com

DATE PREPARED 2020-06-29

DEVICE IDENTIFICATION

Trade/Proprietary Name:	ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
Generic / Common Name:	Dental polymer blanks (discs)
Regulation Number:	872.3770
Classification Name:	Temporary crown and bridge resin
Class:	II
Primary Product Code:	EBG
Secondary Product Codes:	EBI, MQC
Panel:	Dental

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LEGALLY MARKETED PRIMARY PREDICATE DEVICE

Company:	UNION DENTAL S.A.
Device Name:	IDODENTINE blanks
Primary Product Code:	EBG
Secondary Product:	EBI, MQC
510(k) Number:	K150432

LEGALLY MARKETED REFERENCE DEVICE

Company:	ZIRKONZAHN SRL
Device Name:	THERAPON
Primary Product Code:	EBG
510(k) Number:	K180562

INDICATIONS FOR USE

PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.

ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.

PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

DEVICE DESCRIPTION

The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.

All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.

The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.

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DISCUSSION OF NON CLINICAL TESTS

Zirkonzahn carried out performance testing on its devices according to ISO 10477:2018. All tested samples meet the requirements of the standard and show similar values as the predicate device.

Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing.

PREDICATE DEVICE COMPARISON TABLE

In the following comparison table, the most important aspects that support substantial equivalence to the primary predicate device are indicated.

	New devices:ABRO 1, RESITONGINGIVA, PRIME andTHERAPON TRANSPA(K200676)	Primary PredicateDevice:IDODENTINE blanks(K150432)	Comparison
Company	Zirkonzahn srl	UNION DENTAL S.A.	N.A.
Product Code	EBG, EBI, MQC	EBG, EBI, MQC	Same
RegulationNumber	872.3770	872.3770	Same
RegulationName	Temporarycrownandbridge resin	Temporarycrownandbridge resin	Same
Indications foruse	PRIME is used formanufacturingprovisional crowns andbridge frameworks withup to two adjacentpontics in the anteriorand posterior tooth area.ABRO 1 is intended forthe fabrication of dentureteeth; RESITONGINGIVA is intended forthe fabrication of denturebases.PRIME TRANSPA,ABRO 1 TRANSPA andTHERAPON TRANSPAare designed for thecreation of bite splints,orthodontic splints andocclusal splints forbruxism.	Temporary anterior andposterior crownsTemporary anterior andposterior bridges with upto two adjacent ponticsImplant supportedtemporary restorationsMaximum recommendedusage period: 12 monthsRemovable structures fordentures (dental bases)Removable structures fortherapeutic restorations(bite splints or occlusalsplints).	Similar(seediscussionhereunder)
ChemicalComposition	PMMA based withapprox. 1% pigments.	PMMA >99% wt.Pigments <1% wt.	Same
Biocompatibility	Established	Established	Same
Models	Different shapes fordifferent milling systems;different heights;different dental shades	Different shapes fordifferent milling systems;different heights;different dental shades	Same
Shelf life	10 years	None	Different (see discussionhereunder)
PhysicalProperties	According toISO 10477:2018	According toISO 10477:2004	Same
Flexural Strength	≥ 105 MPa	IDODENTINE MULTILAYER: 83 MPaIDODENTINETRANSPA:94 MPa	Similar (see discussionhereunder)
Water absorption	≤ 24 µg/mm³	IDODENTINEMULTILAYER:22.3 µg/mm³IDODENTINE TRASPA:25.8 µg/mm³	Similar (see discussionhereunder)
Water solubility	≤ 0.3 µg/mm³	IDODENTINEMULTILAYER:0.7 µg/mm³IDODENTINETRANSPARENT:0.9 µg/mm³	Similar (see discussionhereunder)
Residualmonomer content(according toISO 20795)	Resiton Gingiva:0.71 wt%Therapon Transpa:< 5.0 wt%	1.4 %	Similar (see discussionhereunder)

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DISCUSSION OF DIFFERENCES AND SIMILARITIES

The subject devices and the primary predicate devices are very similar in the above mentioned aspects. They share the same product codes, regulation number and regulation name, basic chemical composition and available product models. For both devices, biocompatibility was established and physical properties were tested according to ISO 10477.

The indications for use are not identical, but very similar. PRIME as well as the

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predicate devices are intended to fabricate crowns and bridges. Zirkonzahn uses the term provisional, while the predicate uses the term temporary. These two terms are often used interchangeably. Both mean that the dental structure is not definitive and thus the usage period will come to an end. This difference is considered as nonsignificant.

The bridges made of the new device and the predicate are limited to two adjacent pontics. This indication is the same for both compared products.

The predicate blanks can be used for implant supported temporary restorations. This is also true for the new devices, also if not explicitly stated. Union Dental limits this use to 12 months. The dental structures of Zirkonzahn resins must be checked every year by the dentist, who decides whether they can remain in the mouth of the patient or not. Therefore, it is ensured that Zirkonzahn resin structures are not longer in the mouth of the patient as useful.

The new devices as well as the Idodentine blanks can be used for the production of dental prostheses. For this use, usually gingiva and tooth shaded devices are used. In case of Zirkonzahn devices, ABRO 1 and RESITON GINGIVA are used.

The predicate as well as the new devices are used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism. For this use, usually transparent devices are used. In case of Zirkonzahn devices, THERAPON TRANSPA, ABRO 1 TRANSPA and PRIME TRANSPA are used.

The physical properties of the compared devices differ slightly. However, most results indicate that the Zirkonzahn devices performed in a slight better way than the predicates. These differences are considered non-significant. All devices meet the requirements of the standards.

Furthermore, Zirkonzahn indicates a shelf-life for its new devices while the predicate does not. Indicating a shelf life for those devices is customary as polymers are subject to decomposition over time. Thus, it does not represent a significant difference.

CONCLUSION

Based on the comparison made, it can be concluded that the new devices of Zirkonzahn and the IDODENTINE devices of Union Dental S. A. are substantially equivalent. There are not arising any new questions of safety and effectiveness form the comparison above.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.