(205 days)
The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the 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 mesostructures 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 inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems and sizes follows).
The Sirona Dental CAD/CAM System with InLab Software is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of functionality for the control of critical CAD/CAM abutment dimensions. The subject Sirona Dental CAD/CAM System with InLab Software consists of: InLab SW version 18.5, "labside" CAD/CAM software, InEos X5 3D digital desktop scanner, InEos Blue 3D digital desktop scanner, InLab MC X5 milling unit, InLab MCXL milling unit, Sirona TiBase titanium base components, inCoris ZI zirconium mesostructure blocks. The system is utilized to digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components and the zirconium ceramic mesostructure component which is designed using the InLab software and milled using the InLab milling equipment. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement.
The provided text is a 510(k) Premarket Notification from Dentsply Sirona for their Sirona Dental CAD/CAM System with InLab Software. This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance data for a novel artificial intelligence algorithm.
Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set details) are not applicable or not present in this type of FDA submission.
This document indicates that the device is a modification to an already cleared system (K111421), and the current submission (K200191) focuses on bringing the "labside" variant (InLab software) into equivalency with a previously cleared "chairside" variant (CEREC software, K181520), which already incorporated the software design limitation controls.
Here's an analysis based on the provided text, addressing what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria/Performance: The document does not provide a quantitative table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy, which would be typical for an AI/algorithm-based diagnostic device.
- Instead, the "acceptance criteria" are implied by the regulatory standards and successful validation against those standards. The performance is assessed by showing conformity to these standards and the equivalence of its function and safety to the predicate device.
- IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance.
- IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility.
- IEC 62304: Medical device software - Software lifecycle processes.
- Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May, 2005).
- "Software verification and validation testing was conducted to demonstrate that the software's design restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing." This indicates functional performance testing, where the "acceptance" is that the software correctly restricts design parameters.
- "the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library." This confirms data integrity and adherence to design specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of patient data or case numbers. The testing appears to be on the device's functional and safety aspects (e.g., software function, electrical safety), not a clinical dataset of patient images or outcomes.
- Data Provenance: Not applicable in the context of device functional testing. There's no indication of patient data being used for "testing" in the sense of a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document describes a CAD/CAM system for designing dental abutments, not a diagnostic AI system requiring expert-derived ground truth from medical images. The "ground truth" here relates to the engineering specifications and design limitations of the dental abutment, which are inherent to the software's programming and validated through functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical image-based adjudication process is described as this is not a diagnostic imaging AI.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is not mentioned. This is a CAD/CAM system for manufacturing dental prosthetics, not a system providing AI assistance to human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies the software, as a component of the system, operates in a "standalone" fashion in terms of its internal logic for design limitations. However, the overall device (Sirona Dental CAD/CAM System) is inherently human-in-the-loop, as dentists and lab technicians use it for design and manufacturing. The focus of the validation is on the software's ability to enforce design restrictions automatically.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the software's performance is based on engineering specifications and design limitations for dental abutments. These limitations are programmed into the software and verified to be unmodifiable and correctly enforced.
- This is not clinical ground truth derived from patient data or expert consensus on clinical findings.
8. The sample size for the training set
- Not applicable. This CAD/CAM system's software (InLab Software) is not described as utilizing a machine learning or deep learning algorithm that requires a "training set" in the conventional sense of AI. It's a design and manufacturing software, where "training" would refer to its development and programming against predefined dental design rules, not learning from data samples.
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The software's functionality is based on established dental design principles and manufacturing parameters, which are encoded into its programming.
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August 19, 2020
Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401
Re: K200191
Trade/Device Name: Sirona Dental CAD/CAM System with InLab Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: July 24, 2020 Received: July 27, 2020
Dear Karl Nittinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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ence determination does not mean that FDA
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K200191
Device Name
Sirona Dental CAD/CAM System with InLab Software
Indications for Use (Describe)
The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the 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 and CAD/CAM software. Specifically, the inCoris mesostructure major parts: TiBase, 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.XXX) (K083496) in the Camlog Implant The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris System. mesostructure and TiBase two-piece abutment is compatible with the following implant systems:
| Implant Size | |||
|---|---|---|---|
| Manufacturer | Name of Implant System | Platform | Diameter |
| Nobel Biocare | Replace | NP | 3.5 |
| RP | 4.3 | ||
| WP | 5.0 | ||
| 6.0 | 6.0 | ||
| Nobel Biocare | Active | NP | 3.5 |
| RP | 4.3/5.0 | ||
| Nobel Biocare | Branemark | NP | 3.3 |
| RP | 3.75/4.0 | ||
| Straumann | Synocta | NN (3.5mm) | 3.3 |
| RN (4.8mm) | 3.3/4.1/4.8 | ||
| WN (6.5mm) | 4.8 | ||
| Straumann | Bone Level | NC (3.3mm) | 3.3 |
| Straumann | RC (4.1mm/4.8mm) | 4.1/4.8 | |
| Dentsply Sirona Implants | 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 | Xive | 3.4 | 3.4 |
| 3.8 | 3.8 | ||
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| Dentsply Sirona Implants | Osseospeed EV | 3.6 | 3.6 |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| Ankylos | C/X | A, B, C, D | |
| Osseotite | 3.4 | 3.25 | |
| 3.75 | |||
| 4.1 | 4.1 | ||
| 3/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Biomet 3i | 3.4 | 3.25 | |
| 4/3 | |||
| Certain | 4.1 | 3/4/3 | |
| 4.0 | |||
| 4.1 | 4/5/4 | ||
| 5/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Zimmer | Tapered Screw-Vent | 3.5 | 3.7/4.1 |
| 4.5 | 4.7 | ||
| 5.7 | 6 | ||
| Thommen Medical | SPI ELEMENT, SPIELEMENT INICELL, SPICONTACT INICELL | 3.5 | 3.5 |
| 4 | 4 | ||
| 4.5 | 4.5 | ||
| 5 | 5 | ||
| 6 | 6 | ||
| Osstem / Hiossen | Osstem TS Implant SystemHiossen Implant System | MiniRegular | 3.54.0/4.5/5.0/6.0/7.0 |
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| BioHorizons(Internal Connection) | Tapered 3.0,Tapered plus | 3.0 | 3.0/3.4/3.8 |
| Tapered internal | 3.0 | ||
| Tapered plus | 3.5 | 4.6 | |
| Tapered internal, Taperedinternal tissue level | 3.0/3.8 | ||
| Internal dental implant | 3.5 | ||
| Single stage dental implants | 3.5/4.0 | ||
| Tapered Plus | 4.5 | 5.8 | |
| Tapered internal, Taperedinternal tissue level | 4.6 | ||
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| Tapered internal, Taperedinternal tissue level | 5.7 | 5.8 | |
| Internal dental implant,Single stage dental implants | 5.0/6.0 |
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Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/5/Picture/2 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.
510(k) SUMMARY K200191 Sirona Dental CAD/CAM System with InLab Software
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 Date |
Date Prepared: 7-August-2020
Device Name: 2.
- Proprietary Name: Sirona Dental CAD/CAM System with InLab Software .
- Classification Name: Endosseous dental implant abutment. .
- CFR Number: 21 CFR 872.3630 ●
- . Device Class: Class II
- Primary Product Code: ●
PNP (Dental Abutment Design Software for Dental Laboratory)
3. Predicate Devices:
The predicate device that has been identified relating to the substantial equivalence of the Sirona Dental CAD/CAM System with InLab Software is:
| Predicate Devices | 510(k) | Company Name |
|---|---|---|
| Sirona Dental CAD/CAM System | K181520 | Dentsply Sirona |
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Reference Devices:
| Reference Device | Manufacturer | 510(k) Clearance |
|---|---|---|
| Sirona Dental CAD/CAMSystem | Sirona Dental Systems GmbH | K111421 |
| IPS e.max CAD AbutmentSolutions | Ivoclar Vivadent AG | K132209 |
| Telio CAD Abutment Solutions | Ivoclar Vivadent AG | K151564 |
| VITA ENAMIC IS | Vita Zahnfabrik H. RauterGmbH Co. | K153645 |
| CONELOG® Titanium baseCAD/CAM | Altatec GmbH | K143337 |
| iSy® Implant System | Altatec GmbH | K133991 |
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4. Description of Device:
The Sirona Dental CAD/CAM System with InLab Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of functionality for the control of critical CAD/CAM abutment dimensions.
Since its original clearance in February, 2012, under K11142, the Sirona Dental CAD/CAM System has been split into two variants: the "chairside" variant, utilizing the CEREC "chairside" software, which was cleared in October, 2018, under K181520, and the "labside" variant, utilizing the InLab software and subject to this premarket notification.
Under K181520, the predicate Sirona Dental CAD/CAM System with CEREC Software was cleared for the same functionality and abutment software design limitation controls as are the subject of this premarket notification and implemented in the subject Sirona Dental CAD/CAM System with InLab Software variant.
The subject Sirona Dental CAD/CAM System with InLab Software consists of:
- InLab SW version 18.5, "labside" CAD/CAM software ●
- . InEos X5 3D digital desktop scanner.
- . InEos Blue 3D digital desktop scanner.
- . InLab MC X5 milling unit.
- InLab MCXL milling unit.
- Sirona TiBase titanium base components. ●
- inCoris ZI zirconium mesostructure blocks.
As subject to this premarket notification, the Sirona Dental CAD/CAM System with InLab Software is utilized to digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patientspecific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system and the zirconium ceramic mesostructure component which is designed using the InLab software and milled using the InLab milling equipment.
The subject InLab CAD/CAM software is to acquire the digital dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the subject InLab software drives the CAM fabrication of the mesostructure component in the "labside" workflow by utilizing the InLab milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.
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ട്. Indications for Use:
The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the 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 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 mesostructures 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 inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:
| Manufacturer | Name of Implant System | Implant Size | |
|---|---|---|---|
| Platform | Diameter | ||
| Nobel Biocare | Replace | NP | 3.5 |
| RP | 4.3 | ||
| WP | 5.0 | ||
| 6.0 | 6.0 | ||
| Nobel Biocare | Active | NP | 3.5 |
| RP | 4.3/5.0 | ||
| Nobel Biocare | Branemark | NP | 3.3 |
| RP | 3.75/4.0 | ||
| Straumann | Synocta | NN (3.5mm) | 3.3 |
| RN (4.8mm) | 3.3/4.1/4.8 | ||
| WN (6.5mm) | 4.8 | ||
| Straumann | Bone Level | NC (3.3mm) | 3.3 |
| RC (4.1mm/4.8mm | 4.1/4.8 | ||
| Dentsply Sirona Implants | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S |
| 4.5/5.0 | 4.5/5.0/5.0 S | ||
| Xive | 3.4 | 3.4 | |
| 3.8 | 3.8 | ||
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| Osseospeed EV | 3.6 | 3.6 | |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| Dentsply Sirona Implants | 5.4 | 5.4 | |
| Ankylos | C/X | A, B, C, D | |
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| Biomet 3i | Osseotite | 3.4 | 3.25 |
| 3.75 | |||
| 4.1 | 4.1 | ||
| 3/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Biomet 3i | Certain | 3.4 | 3.25 |
| 4/3 | |||
| 3/4/3 | |||
| 4.1 | 4.0 | ||
| 4/5/4 | |||
| 5/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Zimmer | Tapered Screw-Vent | 3.5 | 3.7/4.1 |
| 4.5 | 4.7 | ||
| 5.7 | 6 | ||
| Thommen Medical | SPI ELEMENT, SPI ELEMENT INICELL,SPI CONTACT INICELL | 3.5 | 3.5 |
| 4 | 4 | ||
| 4.5 | 4.5 | ||
| 5 | 5 | ||
| 6 | 6 | ||
| Osstem/Hiossen | Osstem TS Implant System | Mini | 3.5 |
| Hiossen Implant System | Regular | 4.0/4.5/5.0/6.0/7.0 | |
| BioHorizons(Internal Connection) | Tapered 3.0,Tapered plus | 3.0 | 3.0/3.4/3.8 |
| Tapered internal | 3.0 | ||
| Tapered plus | 4.6 | ||
| Tapered internal, Tapered internal tissuelevel | 3.5 | 3.0/3.8 | |
| Internal dental implant | 3.5 | ||
| Single stage dental implants | 3.5/4.0 | ||
| Tapered Plus | 5.8 | ||
| Tapered internal, Tapered internal tissuelevel | 4.5 | 4.6 | |
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| Tapered internal, Tapered internal tissuelevel | 5.7 | 5.8 | |
| Internal dental implant, Single stage dentalimplants | 5.0/6.0 |
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6. Substantial Equivalence:
The subject Sirona Dental CAD/CAM System with InLab Software has the same intended use as the predicate Sirona Dental CAD/CAM System cleared under premarket notification K181520. Both the subject Sirona Dental CAD/CAM System with InLab Software and the predicate device (K181520) are intended for the 3D digital acquisition of the dental topography for use in the design and manufacturing of two-piece "CAD/CAM" dental abutments. As such, the subject Sirona Dental CAD/CAM System with InLab Software and the predicate device cleared under premarket notification K181520 are regulated under 21 CFR 872.3630.
The proposed indications for use of the Sirona Dental CAD/CAM System with InLab Software as subject to this premarket notification are identical to the indication for use of the predicate Sirona Dental CAD/CAM System "chairside" variant as cleared under K181520.
The subject Sirona Dental CAD/CAM System with InLab Software and the predicate Sirona Dental CAD/CAM System cleared under premarket notification K181520 utilize the same TiBase and inCoris ZI zirconia mesostructure materials for the design and fabrication of two-piece, CAD/CAM dental abutments. There are no new TiBase variants introduced in this premarket notification which were not previously cleared under the scope of K181520.
Software controls governing the limitations of critical CAD/CAM abutment design parameters, which were implemented and cleared in the predicate "chairside" variant of the Sirona Dental CAD/CAM System under K181520 are also implemented in the Sirona Dental CAD/CAM System with InLab Software as subject to this premarket notification.
The primary differences between the subject Sirona Dental CAD/CAM System with InLab Software and the predicate Sirona Dental CAD/CAM System cleared under K181520 are the acquisition scanning components and milling equipment models which are utilized for the two CAD/CAM system variants. The subject InLab system incorporates InEos X5 and InEos Blue digital desktop scanning equipment for acquisition of the dental scans, while the predicate "chairside" CAD/CAM System variant cleared under K181520 incorporates the CEREC digital acquisition and intra-oral scanning equipment.
Additionally, the subject Sirona Dental CAD/CAM System with InLab Software and the predicate Sirona Dental CAD/CAM System "chairside" variant cleared in K181520 differ with respect to the CAM milling equipment that is utilized in their respective workflows. The subject InLab system utilizes the InLab MCX5 and InLab MCXL milling units, while the predicate "chairside" system (K181520) utilizes the CEREC MCXL family of milling units.
However, the purpose of the introduction of the Sirona Dental CAD/CAM System reference device (K111421) in support of substantial equivalence is that both the "labside" and "chairside" systems were included under the scope of clearance of K111421 and this clearance was inclusive of the full range of digital scanning acquisition equipment and CAM milling equipment for both the "chairside" and InLab variants, including the InEos X5 and InEos Blue digital scanners, as well as the InLab MCX5 and MCXL milling units which are utilized in the "labside" workflow subject to this premarket notification.
Summary comparison of the intended use, indications for use, and design of the subject Sirona Dental CAD/CAM System with InLab Software and the predicate Sirona Dental CAD/CAM System cleared under K181520 is presented in Tables 6.1 and 6.2.
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| Subject Device | Predicate Device |
|---|---|
| Sirona Dental CAD/CAM Systemwith InLab Software | Sirona Dental CAD/CAM System(K181520) |
Indications for Use
The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the 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 or 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 mesostructures 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 inCoris mesostructure and TiBase twopiece abutment is compatible with the following implant systems:
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. For the 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 mesostructures 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 inCoris mesostructure and TiBase two- piece abutment is compatible with the following implant systems:
| Manufacturer | Implant System | Implant Size | Manufacturer | Implant System | Implant Size | ||
|---|---|---|---|---|---|---|---|
| Platform | Diameter | Platform | Diameter | ||||
| Nobel Biocare | Replace | NP | 3.5 | Nobel Biocare | Replace | NP | 3.5 |
| RP | 4.3 | RP | 4.3 | ||||
| WP | 5.0 | WP | 5.0 | ||||
| 6.0 | 6.0 | 6.0 | 6.0 | ||||
| Nobel Biocare | Active | NP | 3.5 | Nobel Biocare | Active | NP | 3.5 |
| RP | 4.3/5.0 | RP | 4.3/5.0 | ||||
| Branemark | Branemark | NP | 3.3 | Branemark | Branemark | NP | 3.3 |
| RP | 3.75/4.0 | RP | 3.75/4.0 | ||||
| Straumann | Synocta | NN (3.5mm) | 3.3 | Straumann | Synocta | NN (3.5mm) | 3.3 |
| RN (4.8mm) | 3.3/4.1/4.8 | RN (4.8mm) | 3.3/4.1/4.8 | ||||
| WN (6.5mm) | 4.8 | WN (6.5mm) | 4.8 | ||||
| NC (3.3mm) | 3.3 | NC (3.3mm) | 3.3 | ||||
| Straumann | Bone Level | RC (4.1mm/4.8mm) | 4.1/4.8 | Straumann | Bone Level | RC (4.1mm/4.8mm) | 4.1/4.8 |
| Osseospeed | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S | Osseospeed | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S |
| 4.5/5.0 | 4.5/5.0/5.0 S | 4.5/5.0 | 4.5/5.0/5.0 S | ||||
| Dentsply SironaImplants | Xive | 3.4 | 3.4 | Dentsply SironaImplants | Xive | 3.4 | 3.4 |
| 3.8 | 3.8 | 3.8 | 3.8 | ||||
| 4.5 | 4.5 | 4.5 | 4.5 | ||||
| 5.5 | 5.5 | 5.5 | 5.5 | ||||
| Indications for Use (continued) | |||||||
| Manufacturer | Implant System | Implant Size | Manufacturer | Implant System | Implant Size | ||
| Platform | Platform | Diameter | |||||
| Dentsply SironaImplants | Osseospeed EV | 3.6 | Dentsply SironaImplants | Osseospeed EV | 3.6 | 3.6 | |
| 4.2 | 4.2 | 4.2 | |||||
| 4.8 | 4.8 | 4.8 | |||||
| 5.4 | 5.4 | 5.4 | |||||
| Ankylos | C/X | Ankylos | C/X | A,B,C,D | |||
| Biomet 3i | Osseotite | 3.4 | Biomet 3i | Osseotite | 3.4 | 3.25 | |
| 4.1 | 4.1 | ||||||
| 5.0 | 5.0 | ||||||
| Certain | 3.4 | Certain | 3.4 | 3.25 | |||
| 4/3 | |||||||
| 3/4/3 | |||||||
| 4.0 | |||||||
| 4.1 | 4.1 | 4/5/4 | |||||
| 5/4 | |||||||
| 5.0 | 5.0 | 5.0 | |||||
| 4/5 | |||||||
| Zimmer | Tapered Screw Vent | 3.5 | Zimmer | Tapered Screw Vent | 3.5 | 3.7/4.1 | |
| 4.5 | 4.5 | 4.7 | |||||
| 5.7 | 5.7 | 6 | |||||
| Subject DeviceSirona Dental CAD/CAM Systemwith InLab Software | Predicate DeviceSirona Dental CAD/CAM System(K181520) | ||||||
| Indications for Use (continued) | |||||||
| Manufacturer | Implant System | Implant Size | Manufacturer | Implant System | Implant Size | ||
| Platform | Diameter | Platform | Diameter | ||||
| 3.5 | 3.5 | 3.5 | 3.5 | ||||
| 4 | 4 | 4 | 4 | ||||
| Thommen Medical | SPI ELEMENT, SPI ELEMENTINICELL, SPI CONTACT INICELL | 4.5 | 4.5 | Thommen Medical | SPI ELEMENT, SPI ELEMENTINICELL, SPI CONTACT INICELL | 4.5 | 4.5 |
| 5 | 5 | 5 | 5 | ||||
| 6 | 6 | 6 | 6 | ||||
| Mini | 3.5 | Mini | 3.5 | ||||
| Osstem/Hiossen | Osstem TSHiossen | Regular | 4.0/4.5/5.0/6.0/7.0 | Osstem/Hiossen | Osstem TSHiossen | Regular | 4.0/4.5/5.0/6.0/7.0 |
| Tapered 3.0,Tapered plus | 3.0/3.4/3.8 | Tapered 3.0,Tapered plus | 3.0/3.4/3.8 | ||||
| Tapered internal | 3.0 | 3.0 | Tapered internal | 3.0 | 3.0 | ||
| Tapered plus | 4.6 | Tapered plus | 4.6 | ||||
| Tapered internal, Tapered internaltissue level | 3.5 | 3.0/3.8 | Tapered internal, Tapered internaltissue level | 3.5 | 3.0/3.8 | ||
| Internal dental implant | 3.5 | Internal dental implant | 3.5 | ||||
| Single stage dental implants | 3.5/4.0 | Single stage dental implants | 3.5/4.0 | ||||
| BioHorizons(InternalConnection) | Tapered Plus | 5.8 | BioHorizons(InternalConnection) | Tapered Plus | 5.8 | ||
| Tapered internal, Tapered internaltissue level | 4.5 | 4.6 | Tapered internal, Tapered internaltissue level | 4.5 | 4.6 | ||
| Internal dental implant | 4.0 | Internal dental implant | 4.0 | ||||
| Single stage dental implants | 4.0/5.0 | Single stage dental implants | 4.0/5.0 | ||||
| Tapered internal, Tapered internaltissue level | 5.8 | Tapered internal, Tapered internaltissue level | 5.7 | 5.8 | |||
| Internal dental implant, Singlestage dental implants | 5.7 | 5.0/6.0 | Internal dental implant, Singlestage dental implants | 5.7 | 5.0/6.0 |
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Table 6.1: Indications for Use (continued)
Subject Device Sirona Dental CAD/CAM System
with InLab Software
Predicate Device Sirona Dental CAD/CAM System (K1181520)
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Table 6.2: Design
| Subject DeviceSirona Dental CAD/CAM Systemwith InLab Software | Primary Predicate DeviceSirona Dental CAD/CAM System(K181520) |
|---|---|
| CAD/CAM Software Version | |
| InLab Software version 18.5 | CEREC SW version 4.6.1 |
| Acquisition Units | |
| InEos X5 digital desktop scanner | CEREC AC |
| InEos Blue digital desktop scanner | CEREC AC Connect |
| CEREC Omnicam 3D digital intraoral scanner | |
| Milling Unit | |
| InLab MC X5 | CEREC MC |
| InLab MCXL | CEREC MC X |
| CEREC MC XL | |
| CEREC MC XL Premium | |
| Titanium Base Components | |
| Sirona TiBase | Sirona TiBase |
| Diameter: 3.0 mm – 7.0 mm | Diameter: 3.0 mm – 7.0 mm |
| Maximum Angulation of Finished Abutment: | Maximum Angulation of Finished Abutment: |
| 20° | 20° |
| Material (TiBase and Screw) | Material (TiBase and Screw) |
| Titanium alloy | Titanium alloy |
| Mesostructure material | |
| Sirona inCoris ZI zirconium blocks | Sirona inCoris ZI zirconium blocks |
7. Non-Clinical Performance Data
Testing to verify the performance requirements of the modified Sirona Dental CAD/CAM System was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.
Tests included in this premarket notification:
- Testing to verify the conformity of the modified Sirona Dental CAD/CAM System with the requirements of IEC 60601-1: (Medical electrical equipment Part ]: General requirements for basic safety and essential performance).
- . Testing to verify the conformity of the proposed Sirona Dental CAD/CAM System with the requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
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- . Validation of the device's software in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and with deliverables compiled and included with reference to Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May,2005).
- No new designs of TiBase variants or implant interface compatibility are proposed as . subject to this premarket notification. Therefore, no new implant interface geometric compatibility analyses are included in support of substantial in this premarket notification.
- . System validation testing conducted to confirm the design and fabrication workflow of the subject InLab CAD/CAM software, with the defined scanning, acquisition, and milling equipment.
- . No new TiBase variants and no new materials have been introduced as subject to this premarket notification as compared to the scope of the clearance of the predicate device under K181520. Therefore, no new biocompatibility data is included to support the substantial equivalence of the subject Sirona Dental CAD/CAM System with InLab Software.
- The recommended steam sterilization parameters for the steam sterilization of the TiBase components which are compatible with the subject Sirona Dental CAD/CAM System with InLab Software are based on leveraged sterilization information from the predicate device cleared under premarket notification K181520.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the subject InLab CAD/CAM software. Software verification and validation testing was conducted to demonstrate that the software's design restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
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8. Clinical Performance Data
No human clinical data was included in this premarket notification to support the substantial equivalence of the subject Sirona Dental CAD/CAM System with InLab Software.
9. Conclusion Regarding Substantial Equivalence
The information included in this premarket notification supports the substantial equivalence of the subject Sirona Dental CAD/CAM System with InLab Software. The device which is the subject of this premarket notification has the identical intended use as the legally marketed predicate device cleared under premarket notification K181520. The subject device also has the same indications for use and incorporates the same fundamental technology as the predicate device (K181520).
Performance and software validation data are included in this premarket notification to demonstrate the performance of the subject Sirona Dental CAD/CAM System with InLab Software meets its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.
§ 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.)