(238 days)
No
The summary describes a pre-sintered zirconia block used as a material for dental restorations, processed by a CAD/CAM system. There is no mention of AI or ML in the device description, intended use, or performance studies. The CAD/CAM system itself is a predicate device, but the summary focuses on the material block and its compatibility with the system, not on any AI/ML capabilities within the system.
Yes.
The device is intended for use in mandibles and maxillae in support of single cement-retained restorations, which is a therapeutic purpose.
No
This device is a pre-sintered zirconia block used as a component for dental restorations (hybrid abutments or hybrid abutment crowns) and not for diagnosing medical conditions.
No
The device description clearly states that the device is a pre-sintered zirconia block, which is a physical material, not software. While it is used in conjunction with a CAD/CAM system (which includes software), the device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in the mouth for dental restorations (hybrid abutments and hybrid abutment crowns) in conjunction with dental implants. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The device is a pre-sintered zirconia block that is milled into a dental mesostructure. This is a material used for creating a physical dental component.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a dental prosthetic component used in a restorative procedure.
N/A
Intended Use / Indications for 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 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 |
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
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 |
The subject device is procced within the following design parameter range.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing
- Compatibility to standards:
- 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.
- Sterilization:
- The sterilization instructions are validated per ISO 17665-1. Sterilization achieved an SAL of at least 10-6.
- Biocompatibility:
- The biocompatibility of the subject device was evaluated 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.
- 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.
- 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.
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K200191, K190436, K183537, K181520, K191382
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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.
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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) |
- Panel
- N
Dental
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
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 | | | | | | | | | | | | | |
| | | | | | | ternal dental imr | | 5.0/6.0 | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | |
13
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 CEREC |
| Chairside 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 (10 | |
| shades) | 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.
14
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.
15
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.