Who is the manufacturer of KATANA Zirconia ONE For IMPLANT?

Kuraray Noritake Dental, Inc. filed the 510(k) submission for KATANA Zirconia ONE For IMPLANT (K233285).

What is the FDA product code for KATANA Zirconia ONE For IMPLANT?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for KATANA Zirconia ONE For IMPLANT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like KATANA Zirconia ONE For IMPLANT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KATANA Zirconia ONE For IMPLANT

K233285 · Kuraray Noritake Dental, Inc. · NHA · May 24, 2024 · Dental

Device Facts

Record ID	K233285
Device Name	KATANA Zirconia ONE For IMPLANT
Applicant	Kuraray Noritake Dental, Inc.
Product Code	NHA · Dental
Decision Date	May 24, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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.

Device Story

Device is pre-sintered zirconia block for milling into ceramic mesostructures; used as component of two-piece hybrid abutment or hybrid abutment crown. Input: digital design data via Sirona Dental CAD/CAM System (CEREC/inLab software). Transformation: milling of zirconia block into patient-specific shape; cementation to pre-manufactured titanium base (TiBase) using PANAVIA SA Cement Universal. Output: custom hybrid abutment/crown for endosseous dental implants. Used in dental clinics by trained professionals. Healthcare provider uses CAD/CAM software to design mesostructure based on patient anatomy; output provides functional and aesthetic restoration. Benefits: patient-specific fit, restoration of oral function/aesthetics, and compatibility with established implant systems.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 6872:2015 (ceramic materials) and ISO 14801:2016 (dynamic fatigue testing for endosseous dental implants). Biocompatibility evaluated per ISO 10993-1 and ISO 7405. MRI safety assessed via scientific rationale and literature review.

Technological Characteristics

Pre-sintered zirconia block (zirconium oxide ceramic per ISO 6872:2015). Dimensions: one block size with small/large access hole options. Connectivity: integrated into Sirona Dental CAD/CAM System libraries. Sterilization: validated per ISO 17665-1. Design parameters: abutment post height 4.0-16.7mm, angulation 0-20 degrees, wall thickness 0.8-9.5mm.

Indications for Use

Indicated for partially or fully edentulous patients requiring single cement-retained restorations. SBL 3.3 L titanium base use restricted to maxillary lateral incisors and mandibular lateral/central incisors.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Sirona Dental CAD/CAM System with CEREC Chairside software (K193408)

Reference Devices

KATANA Zirconia Block (K190436)
Sirona Dental CAD/CAM System (K181520)
IPS e.max CAD Abutment Solutions- extra systems (K191382)
PANAVIA SA Cement Universal (K183537)

Related Devices

K234018 — CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System · Dentsply Sirona · May 7, 2024
K160626 — ATLANTIS Abutment for HIOSSEN ET implant · Dentsply Sirona · Aug 29, 2016
K241722 — Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment · Elos Medtech Pinol A/S · Sep 13, 2024
K181037 — DIO CAD/CAM Abutment · Dio Corporation · Dec 21, 2018
K242542 — Medentika CAD/CAM Abutments · Medentika GmbH · Apr 22, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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. 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. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ 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 Ohara General Manager Quality Assurance Department | | 4) Contact person in US | Manabu Suzuki Director KURARAY AMERICA, INC. 32 Old Slip, 7th Floor, New York, NY 10005 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (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) | 5) Panel 2. N Dental K200191 Dentsply Sirona #### 3. Predicate and Reference devices 3-1. Primary predicate device 1) 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 4) Applicant name 2) 510(k) number 3) Classification name #### 3-2. Reference devices Reference device 1 1) Trade / Proprietary name 2) 510(k) number 3) Classification name ## 4) Applicant name ## Reference device 2 1) Trade / Proprietary name 2) 510(k) number 3) Classification name 4) Applicant name ## Reference device 3 1) 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 {6}------------------------------------------------ | 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 | {7}------------------------------------------------ ## 4. 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 Compatible titanium bases are shown in below table. | Ti Base | | Compatible System | | | | | |--------------------|------------------------|-------------------|--------------------|------------------------------------|----------|---------| | Name | Dentsply Sirona Ref | Interface size | 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 | | NobelReplace Conical 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 | |--|--|--|--|--|--|---------------------------------------------------------------------------------------| |--|--|--|--|--|--|---------------------------------------------------------------------------------------| {8}------------------------------------------------ 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. OR 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 post height*1 | 4.0 mm ~ 16.7 mm | Minimum value is followed by FDA's recommendation. Maximum value set by considering product's dimension and shrinkage 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 the mesostructure of subject device could applied within those range 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. {9}------------------------------------------------ ## 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 Active NobelReplace 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 | {10}------------------------------------------------ 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 CEREC Chairside software (K193408) | Reference device: Sirona Dental CAD/CAM System (K181520) | Reference device: IPS e.max CAD Abutment Solutions- extra systems (K191382) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. | The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. | IPS e.max CAD Abutment Solutions 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. | For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and 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. The system consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. | For the BH 3.0 S, SSO 3.5 L and S/L 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. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. | The system comprises three parts: - IPS e.max CAD ceramic structure - Ti base - CAD/CAM system. The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. | {11}------------------------------------------------ | Subject device: KATANA Zirconia ONE For IMPLANT | | | Primary predicate device: Sirona Dental CAD/CAM System with CEREC Chairside 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 | TiBase NB RS 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 | TiBase NB RS 4.3 | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | WP | 5.0 | TiBase NB RS 5.0 | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 6.0 | 6.0 | TiBase NB RS 6.0 L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nobel Active, NobelReplace Conical Connection (Nobel Biocare) | NP | 3.5 | TiBase NB A 4.5 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 | TiBase NB A 5.0 L | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Bone Level (Straumann) | NC | 3.3 | TiBase S BL 3.3 L | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | RC | 4.1/4.8 | TiBase S BL 4.1 L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Certain (Biomet 3i) | 3.4 | 3.4 | TiBase B C 3.4 S | S | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 4.1 | 4.1 | TiBase B C 4.1 L | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 5.0 | 5.0 | TiBase B C 5.0 L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tapered Screw-Vent (Zimmer) | 3.5 | 3.7/4.1 | TiBase Z TSV 3.5 L | L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {12}------------------------------------------------ | Subject device: KATANA Zirconia ONE For IMPLANT | | | | | Primary predicate device: | Sirona Dental CAD/CAM System with CEREC Chairside software (K193408) | | Reference device: Sirona Dental CAD/CAM System (K181520) | | | | Reference device: IPS e.max CAD Abutment Solutions- extra systems (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 | 4.2 4.8 | | | 4.2 | 4.2 4.8 | | | | | | | | | | | | | | | ZTSV | | | 4.8 54 | | | | 4.8 5.4 | 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 | 3.25 3.75 | | 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 | 4.7 4.5 | | | | | 3.5 | | | | | | P2244.5020 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 25 | 3.5 | Osstem / Hiossen | | 4.5 | 4 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Thommen Medic | | | 4.5 | | | | | | | | | | | | | | | | | | | | | | | | | Osstem TS Implant Syste | Mini | 3.5 4.0/4.5/5.0/6.0/7.0 | | | | | | | | | | | | | | | | | 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 | | | | | | | | | | | | | | | | | | | | | 4.0 4.0/5.0 | | ternal tissue leve | | | | | | | | | | | | | | | | | | | | | | | ternal dental implant Single stage dental implar | | 5.0/6.0 | | | | | | | | | | | | | | | | | | | 5.8 | | | | | | | | | | | | | | |…