(205 days)
No
The summary focuses on CAD/CAM design and milling, software validation, and hardware components without mentioning AI or ML.
Yes
The device is used to restore the function and aesthetics in the oral cavity by supporting dental implants, which is a therapeutic purpose.
No
The device is designed for the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental abutments, which are restorative components used in conjunction with dental implants. Its purpose is to facilitate the fabrication of these restorations, not to diagnose medical conditions or diseases.
No
The device description explicitly lists hardware components such as scanners and milling units as part of the system, in addition to the software.
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's function in designing and fabricating dental abutments for use with dental implants to restore function and aesthetics in the oral cavity. This is a mechanical and restorative process, not a diagnostic one.
- Device Description: The description details the components of the system (scanners, software, milling units, titanium bases, zirconium blocks) and how they are used to create patient-specific dental abutments. This process involves digital acquisition of anatomical data and subsequent manufacturing, not the analysis of biological samples for diagnostic purposes.
- No Mention of Biological Samples: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
- Anatomical Site: The anatomical site is the oral cavity, specifically the mandible and maxillae, which aligns with a dental restorative device, not an IVD.
In summary, the Sirona Dental CAD/CAM System with InLab Software is a dental CAD/CAM system used for the design and fabrication of dental prosthetics (abutments), not for performing in vitro diagnostic tests.
N/A
Intended Use / 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 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:
(Table of compatible implant systems follows)
Product codes (comma separated list FDA assigned to the subject device)
PNP
Device Description
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.
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 patient-specific 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models. Specific devices are InEos X5 3D digital desktop scanner and InEos Blue 3D digital desktop scanner.
Anatomical Site
Mandibles and maxillae (partially or fully edentulous).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"labside" variant, presumably a dental laboratory setting.
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 Data
- 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).
- 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.
Clinical Performance Data
No human clinical data was included in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111421, K132209, K151564, K153645, K143337, K133991
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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, 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 | ||
| Hiossen Implant System | Mini | ||
| Regular | 3.5 | ||
| 4.0/4.5/5.0/6.0/7.0 | |||
| 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, Tapered | |||
| internal 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, Tapered | |||
| internal tissue level | 4.6 | ||
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| Tapered internal, Tapered | |||
| internal tissue level | 5.7 | 5.8 | |
| Internal dental implant, | |||
| Single stage dental implants | 5.0/6.0 |
3
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)
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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 |
6
Reference Devices:
| Reference Device | Manufacturer | 510(k) Clearance |
|---|---|---|
| Sirona Dental CAD/CAM | ||
| System | Sirona Dental Systems GmbH | K111421 |
| IPS e.max CAD Abutment | ||
| Solutions | Ivoclar Vivadent AG | K132209 |
| Telio CAD Abutment Solutions | Ivoclar Vivadent AG | K151564 |
| VITA ENAMIC IS | Vita Zahnfabrik H. Rauter | |
| GmbH Co. | K153645 | |
| CONELOG® Titanium base | ||
| CAD/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.
8
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 tissue | |||
| level | 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 tissue | |||
| level | 4.5 | 4.6 | |
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| Tapered internal, Tapered internal tissue | |||
| level | 5.7 | 5.8 | |
| Internal dental implant, Single stage dental | |||
| implants | 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 System | |
| with 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 Sirona | |||||||
| Implants | Xive | 3.4 | 3.4 | Dentsply Sirona | |||
| Implants | 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 Sirona | |||||||
| Implants | Osseospeed EV | 3.6 | Dentsply Sirona | ||||
| Implants | 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 Device | |||||||
| Sirona Dental CAD/CAM System | |||||||
| with InLab Software | Predicate Device | ||||||
| Sirona 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 ELEMENT | ||||||
| INICELL, SPI CONTACT INICELL | 4.5 | 4.5 | Thommen Medical | SPI ELEMENT, SPI ELEMENT | |||
| INICELL, SPI CONTACT INICELL | 4.5 | 4.5 | |||||
| 5 | 5 | 5 | 5 | ||||
| 6 | 6 | 6 | 6 | ||||
| Mini | 3.5 | Mini | 3.5 | ||||
| Osstem/Hiossen | Osstem TS | ||||||
| Hiossen | Regular | 4.0/4.5/5.0/6.0/7.0 | Osstem/Hiossen | Osstem TS | |||
| Hiossen | 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 internal | |||||||
| tissue level | 3.5 | 3.0/3.8 | Tapered internal, Tapered internal | ||||
| tissue 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 | |||||||
| (Internal | |||||||
| Connection) | Tapered Plus | 5.8 | BioHorizons | ||||
| (Internal | |||||||
| Connection) | Tapered Plus | 5.8 | |||||
| Tapered internal, Tapered internal | |||||||
| tissue level | 4.5 | 4.6 | Tapered internal, Tapered internal | ||||
| tissue 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 internal | |||||||
| tissue level | 5.8 | Tapered internal, Tapered internal | |||||
| tissue level | 5.7 | 5.8 | |||||
| Internal dental implant, Single | |||||||
| stage dental implants | 5.7 | 5.0/6.0 | Internal dental implant, Single | ||||
| stage 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 Device
Sirona Dental CAD/CAM System
with InLab Software | Primary Predicate Device
Sirona 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.