KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

Device Description

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
Sirona TiBase
. KATANA Zirconia ONE mesostructured blocks

AI/ML Overview

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Device Performance / Standards Met
Material Composition	Identical to reference device KATANA Zirconia Block (K190436)
Biocompatibility	Evaluated per ISO 10993 series and ISO 7405; meets requirements
Material Standards (Zirconia Ceramic)	Conforms to ISO 6872:2015
Dynamic Fatigue Test (Implants)	Performed according to ISO 14801:2016 for worst-case representative devices
Sterilization	Validated per ISO 17665-1, achieving SAL of at least 10^-6
MR Environment Compatibility	Non-clinical worst-case MRI review performed based on scientific rationale and published literature; addressed magnetic displacement force and torque.
CAD/CAM System Compatibility	Confirmed compatible with Sirona Dental CAD/CAM System (K193408, K200191) through a business agreement and disclosed requirements.
Abutment Post Height	4.0 mm ~ 16.7 mm
Angulation	0° ~ 20° (over 20° is contraindication at TiBase)
Wall Thickness	0.8 mm ~ 9.5 mm
Diameter	3.3 mm ~ 6.0 mm (dependent on selected TiBase)
Gingival Height	1.0 mm (dependent on selected TiBase)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.

Kuraray Noritake Dental Inc. Yasujiro Ohara General Manager Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN

May 24, 2024

Re: K233285

Trade/Device Name: KATANA Zirconia ONE For IMPLANT Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: April 26, 2024 Received: April 26, 2024

Dear Yasujiro Ohara:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233285

Device Name KATANA Zirconia ONE For IMPLANT

Indications for Use (Describe)

KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

Compatible implant systems and TiBase are as follows.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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Type of Use (Select one or both, as applicable)

X 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:

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"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."

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24th May 2024 Date:

510(k) Summary

1. 510(k) owner (submitter)

1) Name	Kuraray Noritake Dental Inc.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
3) Contact person	Yasujiro OharaGeneral ManagerQuality Assurance Department
4) Contact person in US	Manabu SuzukiDirectorKURARAY AMERICA, INC.32 Old Slip, 7th Floor, New York, NY 10005Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543
Name of Device

1) Trade / Proprietary name	KATANA Zirconia ONE For IMPLANT
2) CFR Number	21 CFR 872.3630
3) Device Class	Class II
4) Product code
• Primary Product code	NHA (Abutment, Implant, Dental, Endosseous)
• Secondary Product code	PNP (Dental Abutment Design Software for Dental Laboratory)

Panel

Dental

K200191

Dentsply Sirona

3. Predicate and Reference devices 3-1. Primary predicate device

Trade / Proprietary name

Sirona Dental CAD/CAM System with CEREC Chairside software K193408 Abutment, Implant, Dental, Endosseous (21 CFR section 872.3630. Product code: NHA) Dental Abutment Design Software For Dental Laboratory (21 CFR section 872.3630. Product code: PNP) Dentsply Sirona

Applicant name
510(k) number
Classification name

3-2. Reference devices Reference device 1

Trade / Proprietary name 2) 510(k) number 3) Classification name

4) Applicant name

Reference device 2

Trade / Proprietary name 2) 510(k) number 3) Classification name
Applicant name

Reference device 3

Trade / Proprietary name 2) 510(k) number

KATANA Zirconia Block K190436 Powder, Porcelain (21 CFR section 872.6660. Product code: EIH) Kuraray Noritake Dental Inc.

(21 CFR section 872.3630. Product code: PNP)

Sirona Dental CAD/CAM System with InLab Software

Dental Abutment Design Software For Dental Laboratory

IPS e.max CAD Abutment Solutions- extra systems K191382

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3) Classification name	Abutment, Implant, Dental, Endosseous(21 CFR section 872.3630. Product code: NHA
4) Applicant name	Ivoclar Vivadent, AG

Reference device 4

1) Trade / Proprietary name	PANAVIA SA Cement Universal
2) 510(k) number	K183537
3) Classification name	Cement, Dental/Agent, Tooth Bonding, Resin
(21 CFR section 872.3275/872.3200. Product code: EMA/KLE)
4) Applicant name	Kuraray Noritake Dental Inc.

Reference device 5

1) Trade / Proprietary name	Sirona Dental CAD/CAM System
2) 510(k) number	K181520
3) Classification name	abutment, implant, dental, endosseous
(21 CFR section 872.3630. Product code: NHA)
4) Applicant name	Dentsply Sirona

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4. Device Description

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
Sirona TiBase
. KATANA Zirconia ONE mesostructured blocks

Compatible titanium bases are shown in below table.

Ti Base		Compatible System
Name	DentsplySirona Ref	Interfacesize	Manufacturer/ Line	Platform	Diameter
TiBase NB RS 3.5 L	6282474	L	Nobel Biocare	NP	3.5
TiBase NB RS 4.3 L	6282482	L		RP	4.3
TiBase NB RS 5.0 L	6282490	L		WP	5.0
TiBase NB RS 6.0 L	6282508	L		6.0	6.0
TiBase NB A 4.5 L	6308188	L	Nobel Biocare	Nobel Active,	NP	3.5
TiBase NB A 5.0 L	6308253	L		NobelReplaceConical Connection	RP	4.3/5.0
TiBase S BL 3.3 L	6308154	L	Straumann	Bone Level	NC	3.3
TiBase S BL 4.1 L	6308337	L		Bone Level	RC	4.1/4.8
TiBase BC 3.4 S	6308048	S	Biomet 3i	Certain	3.4	3.4
TiBase B C 4.1 L	6308097	L		Certain	4.1	4.1
TiBase B C 5.0 L	6308121	L		Certain	5.0	5.0
TiBase Z TSV 3.5 L	6282581	L	Zimmer	Tapered Screw-Vent	3.5	3.7/4.1
TiBase Z TSV 4.5 L	6282599	L		Tapered Screw-Vent	4.5	4.7
TiBase Z TSV 5.7 L	6282607	L		Tapered Screw-Vent	5.7	6

						Table 4: Compatibility of intended Sirona TiBase with KATANA Zirconia ONE For IMPLANT
--	--	--	--	--	--	---------------------------------------------------------------------------------------

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The subject device is procced within the following design parameter range.

Image /page/8/Figure/2 description: The image shows three diagrams comparing a hybrid abutment and a hybrid abutment crown. Each diagram includes measurements of less than 20 degrees and greater than or equal to 0.8mm. The diagrams illustrate the differences in the angle and size of the abutments and crowns.

The minimum wall thickness of the restoration must be 0.8 mm.

The parameters of this product for fabricating prosthetics are as following:

Item	Parameter	Remark
a) Abutment postheight*1	4.0 mm ~ 16.7 mm	Minimum value is followed by FDA's recommendation.Maximum value set by considering product's dimension andshrinkage of block.
b) Angulation	0° ~ 20°	Angulation over 20° is contraindication at TiBase.
c) Wall thickness	0.8 mm ~ 9.5 mm	Range of wall thickness is limited by allowance of access hole,the dimensions and shrinkage of block.
d) Diameter	3.3 mm ~ 6.0 mm*2	This value set by Dentsply Sirona. It was confirmed that themesostructure of subject device could applied within thoserange of diameter.
e) Gingival height	1.0 mm*2	This value set by Dentsply Sirona.

*1 The abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.

*2 Parameters of diameter and gingival height are depended on a selected TiBase.

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5. Substantial Equivalence Discussion

5-1. Indications for Use / Intended Use

It is described that the indications for use of the subject device set as followings:

KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in conjunction with TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows:

Implant system(Manufacturer)	Platform	Sirona TiBase Name	Size
Replace, Replace Select(Nobel Biocare)	NP	TiBase NB RS 3.5 L	L
	RP	TiBase NB RS 4.3 L	L
	WP	TiBase NB RS 5.0 L	L
	6.0	TiBase NB RS 6.0 L	L
Nobel ActiveNobelReplace Conical Connection(Nobel Biocare)	NP	TiBase NB A 4.5 L	L
	RP	TiBase NB A 5.0 L	L
Bone Level(Straumann)	NC (3.3 mm)	TiBase S BL 3.3 L	L
	RC (4.1 mm / 4.8 mm)	TiBase S BL 4.1 L	L
Certain(Biomet 3i)	3.4	TiBase B C 3.4 S	S
	4.1	TiBase B C 4.1 L	L
	5.0	TiBase B C 5.0 L	L
Tapered Screw-Vent(Zimmer)	3.5	TiBase Z TSV 3.5 L	L
	4.5	TiBase Z TSV 4.5 L	L
	5.7	TiBase Z TSV 5.7 L	L

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This Indications for Use is substantially equivalence device (IPS e.max CAD Abutnent Solutions- extra systems, K.191382 / the predicate device (Sirona Dental CAD/CAM System with CEREC Chairside software (K193408)) the reference device (Sirona Dental CAD/CAM System (K181520) ). It is the description as follows that we conducted the comparison between the subject device and the reference device.

Subject device:KATANA Zirconia ONE For IMPLANT	Primary predicate device:Sirona Dental CAD/CAM System with CERECChairside software (K193408)	Reference device:Sirona Dental CAD/CAM System(K181520)	Reference device:IPS e.max CAD Abutment Solutions- extrasystems (K191382)
KATANA Zirconia ONE For IMPLANT isintended for use in partially or fully edentulousmandibles and maxillae in support of singlecement-retained restorations.	The Sirona Dental CAD/CAM System withCEREC Chairside Software is intended for usein partially or fully edentulous mandibles andmaxillae in support of single or multiple-unitcement retained restorations.	The Sirona Dental CAD/CAM System isintended for use in partially or fully edentulousmandibles and maxillae in support of single ormultiple-unit cement retained restorations.	IPS e.max CAD Abutment Solutions isintended for use in partially or fullyedentulous mandibles and maxillae in supportof single cement-retained restorations.
For the SBL 3.3 L titanium bases, the indicationis restricted to the replacement of single lateralincisors in the maxilla and lateral and centralincisors in the mandible.KATANA Zirconia ONE For IMPLANT is usedin combination with the TiBase and SironaDental CAD/CAM System. KATANA ZirconiaONE For IMPLANT cemented to the TiBase isrecommended for two-piece hybrid abutments forsingle tooth restorations and hybrid abutmentcrowns, used in conjunction with endosseousdental implants.	For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, andSBL 3.3 L titanium bases, the indication isrestricted to the replacement of single lateralincisors in the maxilla and lateral and centralincisors in the mandible.The system consists of three major parts:TiBase, inCoris mesostructure and CAD/CAMsoftware. Specifically, the inCoris mesostructureand TiBase components make up a two- pieceabutment which is used in conjunction withendosseous dental implants to restore thefunction and aesthetics in the oral cavity. TheinCoris mesostructure may also be used inconjunction with the Camlog Titanium baseCAD/CAM (types K2244.XXXX) (K083496) inthe Camlog Implant System. The CAD/CAMsoftware is intended to design and fabricate theinCoris mesostructure.	For the BH 3.0 S, SSO 3.5 L and S/L 3.3 Ltitanium bases, the indication is restricted to thereplacement of single lateral incisors in themaxilla and lateral and central incisors in themandible.The system consists of three major parts: TiBase,inCoris mesostructure, and CAD/CAM software.Specifically, the inCoris mesostructure andTiBase components make up a two-pieceabutment which is used in conjunction withendosseous dental implants to restore thefunction and aesthetics in the oral cavity. TheinCoris mesostructure may also be used inconjunction with the Camlog Titanium baseCAD/CAM (types K2244.XXXX) (K083496) inthe Camlog Implant System. The CAD/CAMsoftware is intended to design and fabricate theinCoris mesostructure.	The system comprises three parts:- IPS e.max CAD ceramic structure- Ti base- CAD/CAM system.The IPS e.max CAD ceramic structurecemented to the Ti base is recommended fortwo-piece hybrid abutments for single toothrestorations and hybrid abutment crowns, usedin conjunction with endosseous dentalimplants.

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Subject device:KATANA Zirconia ONE For IMPLANT			Primary predicate device:Sirona Dental CAD/CAM System with CERECChairside software (K193408)	Reference device:Sirona Dental CAD/CAM System (K181520)	Reference device:IPS e.max CAD Abutment Solutions- extra systems (K191382)
Compatible implant systems and Ti-bases are as follows.			The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems	The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems	The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:-Implant Systems:- Dentsply Sirona: AstraTech OsseoSpeed,Frialit/Xive (K130999, K013867)- BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),- Osstem: TS Implant System (K121585)- Straumann: Tissue Level RN/WN (K061176)- Nobel Biocare: Branemark (K022562)- Zimmer: Tapered Screw-Vent (K061410)- Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)- CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)- Titanium Bases
Implant system (Manufacturer)	Platform	Diameter	Sirona Ti-base Name	Size
Replace,Replace Select(Nobel Biocare)	NP	3.5	TiBaseNBRS 3.5		Manufacturer Name of Implant System Implant Size Platform Diameter Nobel Biocare Replace NP 3.5 RP 4.3 Active NP 3.5 RP 4.3/5.0 Branemark NP 3.3 RP 3.75/4.0 Synocta NN (3.5mm) 3.3 RN (4.8mm) 3.3/4.1/4.8 Straumann WN (6.5mm) 4.8 Bone Level NC (3.3mm) 3.3 RC (4.1mm/4.8mm 4.1/4.8 Osseospeed 3.5/4.0 3.5 S / 4.0 S 4.5/5.0 4.5/5.0/5.0 S Dentsply Sirona Implants 3.4 3.4 3.8 3.8 Xive 4.5 4.5 5.5 5.5
	RP	4.3	TiBaseNBRS 4.3	L
	WP	5.0	TiBaseNBRS 5.0	L
	6.0	6.0	TiBaseNBRS 6.0L
Nobel Active,NobelReplaceConicalConnection(Nobel Biocare)	NP	3.5	TiBaseNB A4.5 L	L	Manufacturer Name of Implant System Implant Size Platform Diameter Nobel Biocare Replace NP 3.5 RP 4.3 Active NP 3.5 RP 4.3/5.0 Branemark NP 3.3 RP 3.75/4.0 Synocta NN (3.5mm) 3.3 RN (4.8mm) 3.3/4.1/4.8 Straumann WN (6.5mm) 4.8 Bone Level NC (3.3mm) 3.3 RC (4.1mm/4.8mm 4.1/4.8 Osseospeed 3.5/4.0 3.5 S / 4.0 S 4.5/5.0 4.5/5.0/5.0 S Dentsply Sirona Implants 3.4 3.4 3.8 3.8 Xive 4.5 4.5 5.5 5.5
	RP	4.3/5.0	TiBaseNB A5.0 L	L
Bone Level(Straumann)	NC	3.3	TiBaseS BL3.3 L	L
	RC	4.1/4.8	TiBaseS BL4.1 L
Certain(Biomet 3i)	3.4	3.4	TiBaseB C3.4 S	S
	4.1	4.1	TiBaseB C4.1 L	L
	5.0	5.0	TiBaseB C5.0 L
TaperedScrew-Vent(Zimmer)	3.5	3.7/4.1	TiBaseZ TSV3.5 L	L

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			Primary predicate device:	Sirona Dental CAD/CAM System with CERECChairside software (K193408)		Reference device:Sirona Dental CAD/CAM System(K181520)				Reference device:IPS e.max CAD Abutment Solutions- extrasystems (K191382)
4.5	4.7	TiBase			mplant Siz		Manufacture		Implant Size		Camlog TiBase
		ZTSV	Manufacturer		Platforn	Diameter			Platform
		4.5 L			36	ર 6			36
5.7	6	TiBase			4.2	4.24.8			4.2	4.24.8
		ZTSV			4.854				4.85.4	54						C2244,3348
		5.7 L	Dentsply Sirona Implants	Ankylos	C/X	A. B. C. D		Ankylos	C/X	A. B. C. D						7244.384
					3.0	3.0			3.4	3.25						CD3AA 434
				sseospeed TX	3.5/4/	3.5/4/1				3.75						2244.504
					4.5/5.1	4.5/5 0			4.1	4.1
					3.4	3.253.75		Osscotite		3/4
										5.0
					4 1	4.1			5.0	4/2
						3/4				3.25
					5.0	5.0	Biomet 3i
					4/5			3.4	4/3						2242-382
		Biomet 3i			3.25				3/4/3
			3.4	4/3		Certain		4.0
				3/4/3				4/5/4					AD/CAM, for @ 4.3 mm
			Certain		4.0				5/4
					4.1	4/5/4				5.0
					ડાવ			5.0	4/5						C2242,5020
						5.0				3.7/4.1		Sy 3.8 / 4.4 / 5.0				92244.440
					5.0	4/5			4.5	4.7				1.8/	5 man GM 2.0 mes	P2244,442
					35	3.7/4.1		PI FLEMENT SPI						44	2 miss. GM O.R micro	P2244.5008
			Zimmer	apered Screw-Ve	4.74.5					3.5						P2244.5020

					25	3.5	Osstem / Hiossen		4.5	4 5

			Thommen Medic			4.5
								Osstem TS Implant Syste	Mini	3.54.0/4.5/5.0/6.0/7.0
				Osstem TS Implant System	More	3.5
				liossen Implant Syst		4.0/4.5/5.0/6.0/7.0
							Manufacturer

										Diameter
			Manufacturer		Implant Size			Tapered 3.0.Tanered n		3.0/3.4/3.1
						Diameter
						3.0/3.4/3.8
						3.0				3.0/3.8
						4.6
						3.0/3.8				3.5/4.0
						3.5
				3.5/4.0		anered internal Taner
	BioHorizon			5.8		ternal dental im		4.0
	Internal Conne			4.6				4.0/5.0
						Tapered internal, Tapere		58
						4.04.0/5.0		ternal tissue leve
								ternal dental implantSingle stage dental implar		5.0/6.0
						5.8
				ternal dental imr		5.0/6.0

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5-2. Design

In the design such as the combination, indications for use, KATANA Zirconia ONE For IMPLANT is substantially equivalent to the primary predicate device and the reference device.

Design
Subject device:	Primary predicate device:
KATANA Zirconia ONE For IMPLANT	Sirona Dental CAD/CAM System with CERECChairside software (K193408)
CAD/CAM Software Version
CEREC SW, InLab Software	CEREC SW
Titanium Base Components
Sirona TiBase	Sirona TiBase
Diameter: 3.3 mm - 6.0 mm	Diameter: 3.0 mm - 7.0 mm
Abutment Angulation	Maximal Abutment Angulation
0° ~ 20°	20°
Material (TiBase and Screw)	Material (TiBase and Screw)
Titanium alloy	Titanium alloy
Mesostructure material
KATANA Zirconia ONE (For IMPLANT)	inCoris ZI
Block Material:	Block Material:
Zirconium oxide ceramic ISO 6872:2015	Zirconium oxide ceramic
Abutment post height*1	Block Dimensions:
min.4.0 mm ~ max.16.7 mm	24 mm (L) × 23 mm (W) × 21.5 mm (H)
Angulation
0° ~ 20°
Wall thickness
min.0.8 mm ~ max.9.5 mm
Diameter
min.3.3 mm ~ max.6.0 mm
Gingival height
1.0 mm
Available Shades:	Available Shades:
A1, A2, A3, A3.5, B1, B2, C1, C2, D2, NW (10shades)	F0.5, F2

*1 The abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.

5-3. Material Composition of mesostructured material

The mesostructured material of KATANA Zirconia ONE For IMPLANT has the identical composition as the reference device, KATANA Zirconia Block (K190436).

5-4. Technological Characteristics

The mesostructured material of KATANA Zirconia ONE For IMPLANT is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form.

The mesostructured material of KATANA Zirconia ONE For IMPLANT and its predicate device (inCoris ZI, IPS e.max CAD Abutment Solutions) do not share same chemical properties. However it was considered that there were no differences among the mesostructure material of KATANA Zirconia ONE For IMPLANT, the predicate device as the following reasons.

. The mesostructure material of KATANA Zirconia ONE For IMPLANT is similar with minor differences in the compatible implant systems. The intended use for each is similar. Mesostructure material of KATANA Zirconia ONE For IMPLANT, the inCoris ZI, and IPS e.max CAD have similar functions as the ceramic for the mesostructure to complete the two-piece abutment. Moreover, all three are mesostructures intended to serve as milled components of dental implant abutment crowns, and all three share implant compatibilities with the same Sirona TiBase devices.

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On the other hand, the mesostructure material of KATANA Zirconia ONE For IMPLANT has have an access hole compatible with intended TiBase (K193408, K200191) to allow the mesostrcture or abutment crown bonded to a titanium base to be connected to the implant. The mesostructure material of KATANA Zirconia ONE For IMPLANT has identical chemical properties as the reference device, KATANA Zirconia Block (K190436) in geometry, with the exception of an access hole.

It was considered that there were no differences concerning chemical compositions and physical properties between the mesostructure material of KATANA Zirconia ONE For IMPLANT and the reference device (KATANA Zirconia Block) as the following reasons.

. The mesostructure material of KATANA Zirconia ONE For IMPLANT has the identical chemical composition, equivalent biocompatibility and meet physical properties such as ISO 6872:2015.
Concerning the primary predicate device, Sirona Dental CAD/CAM System with CEREC Chairside software (K193408), the indication for use of the subject device is equivalent.

The subject device is a new mesostructured material to this system and is equivalent in technical characteristics to the mesostructure material of the predicate device. In addition, Titanium Base (TiBase) and CAD/CAM systems that have been certified under this system is used for the subject device.

For these reasons, it was selected as the predicate device because it was judged to be the most similar to the subject device. The mesostructure material of the subject device was compared with InCoris, which is as the mesostructure included Sirona Dental CAD/CAM System.

For this abutment system, the titanium Ti-Base already received 510(k) clearance (K193408, K200191, K181520) by Dentsply Sirona for use with the Sirona CAD/CAM System for each of the identified compatible implant bodies.

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7. Non-Clinical Performance Testing

7-1. Compatibility to standards

KATANA Zirconia ONE For IMPLANT:

. ISO 6872: 2015 - Dentistry - Ceramic materials
. ISO 14801: 2016 – Dentistry – Implants – Dynamic fatigue test for endosseous dental implants

Fatigue testing was performed for the worst- case representative devices according to ISO 14801.

7-2. Sterilization

The sterilization instructions are validated per ISO 17665-1. Sterilization achieved an SAL of at least 10-6.

7-3. Biocompatibility

We evaluated the biocompatibility of the subject device referring to "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff", ISO 10993 series and ISO 7405.

7-4. MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the subject device in the MRI environment using scientific rationale and published literature (e.g., Terry O et al. Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices. Journal of Testing and Evaluation. doi: 10.1520, JTE20190096, Vol. 49, No. 2, 2021), based on the entire system including all variations (all compatible implant bodies, titanium dental abutments, and fixation screws: refer to the table "Compatible implant systems and TiBase" in Indication for use) and material composition.

Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

7-5. Compatibility with the CAD/CAM system of Dentsply Sirona

Dentsply Sirona distributes CAD/CAM systems which shall include the currently marketed devices and any enhancements, improvements, or successors thereto (collectively the "Devices") being used to mill inlays, onlays, crowns, crown and bridge frameworks, and similar dental restorations from pre-manufactured blocks of various composition (known and referenced as "Blanks").

There is the business agreement between Kuraray Noritake Dental, which manufactures the pre-manufactured blocks, and Dentsply Sirona, which distributes the devices. This Agreement provides for the licensing from Dentsply Sirona to Kuraray Noritake Dental of the Brands and the know-how required for the manufacturing of KURARAY branded block-formed Blanks using the Devices and their control software.

And under the above business agreement, Dentsply Sirona disclosed to Kuraray Noritake its requirements for the mesostructure, such as shape and size. Kuraray Noritake Dental has developed a manufacturing process that stably reproduced this mesostructure to meet Dentsply Sirona's requirements.

This is the cooperative relationship between Kuraray Noritake Dental and Dentsply Sirona to demonstrate the compatibility of the mesostructure and TiBase based on the business agreement.

8. Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of the subject device.

9. Conclusion

This submission information including the nonclinical testing provided supports that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)