K Number
K181520
Device Name
Sirona Dental CAD/CAM System
Manufacturer
Date Cleared
2018-10-11

(122 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (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 follows).
Device Description
The Sirona Dental CAD/CAM System 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 a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and 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. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL 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.
More Information

No
The summary describes standard CAD/CAM software for designing and fabricating dental abutments based on digital scans. There is no mention of AI or ML algorithms for tasks like automated design suggestions, image analysis for diagnosis, or predictive modeling. The focus is on controlling dimensions and compatibility with implant systems.

No

The system designs and fabricates components (TiBase, inCoris mesostructure) of a two-piece abutment used with dental implants. While these abutments help restore function and aesthetics, the device itself is a manufacturing system and not directly intended for diagnosis, treatment, or prevention of disease.

No

The device is described as a CAD/CAM system for designing and fabricating dental abutments used with implants, rather than for diagnosing medical conditions.

No

The device description explicitly lists multiple hardware components as part of the system, including digital acquisition units, a 3D digital intraoral scanner, CAM milling units, and physical titanium base components and zirconium blocks. While software is a key part of the system, it is not the sole component.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
  • Device Function: The Sirona Dental CAD/CAM System is used to design and fabricate dental abutments for use with dental implants. This is a process of creating a physical medical device for implantation, not performing a diagnostic test on a biological sample.
  • Intended Use: The intended use clearly states the system is for "support of single or multiple-unit cement retained restorations" and "to restore the function and aesthetics in the oral cavity." This describes a restorative and prosthetic function, not a diagnostic one.
  • Device Description: The description details the components (scanner, software, milling unit, titanium bases, zirconium blocks) and the process of scanning, designing, and milling dental abutments. This aligns with a manufacturing and fabrication process for a medical device.

Therefore, the Sirona Dental CAD/CAM System, as described, falls under the category of a dental prosthetic/restorative device system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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 mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (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:
Nobel Biocare Replace, Active, Branemark
Straumann Synocta, Bone Level
Dentsply Sirona Implants Osseospeed, Xive, Osseospeed EV, Ankylos
Biomet 3i Osseotite, Certain
Zimmer Tapered Screw-Vent
Thommen Medical SPI ELEMENT, SPI ELEMENT INICELL, SPI CONTACT INICELL
Osstem / Hiossen Osstem TS Implant System, Hiossen Implant System
BioHorizons (Internal Connection) Tapered 3.0, Tapered plus, Tapered internal, Tapered internal tissue level, Internal dental implant, Single stage dental implants

Product codes (comma separated list FDA assigned to the subject device)

NHA, PNP

Device Description

The Sirona Dental CAD/CAM System 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 a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added.

Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems.

The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of:

  • CEREC SW version 4.6.1, "chairside" CAD/CAM software
  • CEREC AC digital acquisition unit
  • CEREC AC Connect digital acquisition unit
  • CEREC Omnicam 3D digital intraoral scanner
  • CEREC MCXL product family of CAM milling units
  • Sirona TiBase titanium base components
  • inCoris ZI zirconium mesostructure blocks

As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and 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.

The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL 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

digital intraoral scanner

Anatomical Site

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 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 1: 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).
  • Dynamic fatigue testing of new TiBase variants in worst-case construct according to ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants).
  • Compatibility analyses of new TiBase interface geometries with original manufacturer's implant connection geometries. Compatibility analysis consisted of reverse engineering on OEM implant body, OEM implant abutment, and OEM implant screw, or by manufacturing agreement.
  • System validation testing conducted to confirm the design and fabrication workflow of the "chairside" CAD/CAM software, CEREC SW version 4.6.1, with the defined scanning, acquisition, and milling equipment.
  • New TiBase variants are composed of the identical materials and are fabricated utilizing the same methods as the components cleared under K111421. Therefore, no new biocompatibility data is included to support the substantial equivalence of the modified Sirona Dental CAD/CAM System.
  • Recommended parameters for the steam sterilization of the subject TiBase components have been validated according to EN ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and with reference to ANSVAAMI ST79:2010 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities).
  • The subject TiBase components are provided non-sterilized by the end user. They are composed of the identical titanium alloy material and are provided in the same packaging configuration as the predicate TiBase components cleared under K11142. No shelf life testing was included to support substantial equivalence.

Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the "chairside" CAD/CAM software, CEREC SW version 4.6.1. Software verification and validation testing was conducted to demonstrate that the 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.

No human clinical data was included in this premarket notification to support the substantial equivalence of the modified Sirona Dental CAD/CAM System.

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.

K111421

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.

K121585, K140934, K101096, K093615, K090154, K130999, K140347, K083805, K143022, K071638, K093321, K042429, K132209, K151564, K153564

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 11, 2018

Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401

Re: K181520

Trade/Device Name: Sirona Dental CAD/CAM System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: September 7, 2018 Received: September 10, 2018

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

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K181520

Device Name Sirona Dental CAD/CAM System

Indications for Use (Describe)

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 mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (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:

ManufacturerName of Implant SystemImplant Size
PlatformDiameter
Nobel BiocareReplaceNP3.5
RP4.3
WP5.0
6.06.0
Nobel BiocareActiveNP3.5
RP4.3/5.0
Nobel BiocareBranemarkNP3.3
RP3.75/4.0
StraumannSynoctaNN (3.5mm)3.3
RN (4.8mm)3.3/4.1/4.8
WN (6.5mm)4.8
Bone LevelNC (3.3mm)3.3
RC (4.1mm/4.8mm4.1/4.8
Dentsply Sirona ImplantsOsseospeed3.5/4.03.5 S / 4.0 S
4.5/5.04.5/5.0/5.0 S
Xive3.43.4
3.83.8
4.54.5
5.55.5
ManufacturerName of Implant SystemImplant Size
PlatformDiameter
Dentsply Sirona ImplantsOsseospeed EV3.63.6
4.24.2
4.84.8
5.45.4
AnkylosC/XA, B, C, D
Osseotite3.43.25
3.75
4.14.1
3/4
5.05.0
4/5
Biomet 3iCertain3.25
3.44/3
3/4/3
4.14.0
4/5/4
5/4
5.05.0
4/5
ZimmerTapered Screw-Vent3.53.7/4.1
4.54.7
5.76
Thommen MedicalSPI ELEMENT, SPI
ELEMENT INICELL, SPI
CONTACT INICELL3.53.5
44
4.54.5
55
66
Osstem / HiossenOsstem TS Implant System
Hiossen Implant SystemMini
Regular3.5
4.0/4.5/5.0/6.0/7.0
ManufacturerName of Implant SystemImplant Size
PlatformDiameter
BioHorizons
(Internal Connection)Tapered 3.0,Tapered plus3.03.0/3.4/3.8
Tapered internal3.0
Tapered plus4.6
Tapered internal, Tapered
internal tissue level3.53.0/3.8
Internal dental implant3.5
Single stage dental implants3.5/4.0
Tapered Plus5.8
Tapered internal, Tapered
internal tissue level4.54.6
Internal dental implant4.0
Single stage dental implants4.0/5.0
Tapered internal, Tapered
internal tissue level5.75.8
Internal dental implant,
Single stage dental implants5.0/6.0

3

4

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

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 contains the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved or folded form. To the right of the shape are the words "Dentsply" stacked on top of "Sirona", both in a simple, sans-serif font. The color of the logo and text is a muted gray.

SECTION 5. 510(k) SUMMARY

for

Sirona Dental CAD/CAM System

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 Prepared: 11-October-2018

    1. Device Name:
    • Proprietary Name: Sirona Dental CAD/CAM System . Classification Name: Endosseous dental implant abutment. ● CFR Number: 21 CFR 872.3630 ● Device Class: Class II ● Primary Product Code: NHA (Abutment, Implant, Dental Endosseous) ●

Laboratory)

  • . Secondary Product Code: PNP (Dental Abutment Design Software for Dental

3. Predicate and Reference Devices:

The predicate device that has been identified relating to the substantial equivalence of the Sirona Dental CAD/CAM System is:

Predicate Device510(k)Company Name
Sirona Dental CAD/CAM SystemK111421Sirona Dental Systems GmbH

6

Reference Devices:

Reference DeviceManufacturer510(k) Clearance
TS Implant SystemOsstem Implant Co., Ltd.K121585
Hiossen Implant SystemHiossen, Inc.K140934, K101096
SPI Element, SPI Element
INICELL, SPI Contact
INICELLThommen Medical AGK093615, K090154
Osseospeed EV (AT EV)
ImplantsDentsply Sirona ImplantsK130999
Ankylos C/X Implant SystemDentsply Sirona ImplantsK140347, K083805
BioHorizons Implant System
(internal connection)BioHorizons Implant Systems,
Inc.K143022, K071638, K093321,
K042429
IPS e.max CAD Abutment
SolutionsIvoclar Vivadent AGK132209
Telio CAD Abutment SolutionsIvoclar Vivadent AGK151564
VITA ENAMIC ISVita Zahnfabrik H. Rauter
GmbH Co.K153564

7

4. Description of Device:

The Sirona Dental CAD/CAM System 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 a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added.

Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems.

The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of:

  • CEREC SW version 4.6.1, "chairside" CAD/CAM software ●
  • CEREC AC digital acquisition unit
  • CEREC AC Connect digital acquisition unit ●
  • CEREC Omnicam 3D digital intraoral scanner ●
  • CEREC MCXL product family of CAM milling units ●
  • Sirona TiBase titanium base components
  • inCoris ZI zirconium mesostructure blocks

As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and 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.

The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL 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

న్ Indications for Use:

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:

ManufacturerName of Implant SystemImplant Size
PlatformDiameter
ReplaceNP3.5
RP4.3
WP5.0
6.06.0
Nobel BiocareActiveNP3.5
RP4.3/5.0
BranemarkNP3.3
RP3.75/4.0
SynoctaNN (3.5mm)3.3
RN (4.8mm)3.3/4.1/4.8
StraumannWN (6.5mm)4.8
Bone LevelNC (3.3mm)3.3
RC (4.1mm/4.8mm4.1/4.8
Osseospeed3.5/4.03.5 S / 4.0 S
4.5/5.04.5/5.0/5.0 S
Xive3.43.4
3.83.8
4.54.5
Dentsply Sirona Implants5.55.5
Osseospeed EV3.63.6
4.24.2
4.84.8
5.45.4
AnkylosC/XA, B, C, D
ManufacturerName of Implant SystemImplant Size
PlatformDiameter
Biomet 3iOsseotite3.43.25
3.75
4.14.1
3/4
5.05.0
4/5
3.43.25
Biomet 3iCertain4/3
3/4/3
4.0
4.14/5/4
5/4
5.0
5.04/5
ZimmerTapered Screw-Vent3.53.7/4.1
4.54.7
5.76
Thommen MedicalSPI ELEMENT, SPI ELEMENT INICELL,
SPI CONTACT INICELL3.53.5
44
4.54.5
55
66
Osstem/HiossenOsstem TS Implant SystemMini3.5
Hiossen Implant SystemRegular4.0/4.5/5.0/6.0/7.0
Tapered 3.0,Tapered plus3.0/3.4/3.8
BioHorizons
(Internal Connection)Tapered internal3.03.0
Tapered plus4.6
Tapered internal, Tapered internal tissue
level3.53.0/3.8
Internal dental implant3.5
Single stage dental implants3.5/4.0
Tapered Plus5.8
Tapered internal, Tapered internal tissue
level4.54.6
Internal dental implant4.0
Single stage dental implants4.0/5.0
Tapered internal, Tapered internal tissue
level5.8
Internal dental implant, Single stage dental
implants5.75.0/6.0

9

10

6. Substantial Equivalence:

The modified Sirona Dental CAD/CAM System has the same intended use as the predicate Sirona Dental CAD/CAM System cleared under premarket notification K111421. Both the modified Sirona Dental CAD/CAM System and the predicate device are intended as optical impression systems for the 3D digital acquisition of the topography of teeth for use in the design and manufacturing of two-piece "CAD/CAM" dental abutments. As such the subject Sirona Dental CAD/CAM System and the predicate device cleared under premarket notification K111421 are regulated under 21 CFR 872.3630.

The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification and the predicate cleared under premarket notification K111421 include the same scanning, acquisition, and milling equipment, and utilize the same TiBase and inCoris ZI zirconia mesostructure materials for the design and fabrication of two-piece, CAD/CAM dental abutments.

The primary differences between the modified Sirona Dental CAD/CAM System and the predicate device cleared in K111421 are the implementation under this premarket notification of the new version of the CAD/CAM "chairside" software, the CEREC SW version 4.6.1, and the extension of the available variants of the existing Sirona TiBase titanium base component offerings to facilitate compatibility with additional dental implant systems.

As subject to this premarket notifications for use of the Sirona CAD/CAM System have been modified relative to the expansion of implant systems to which the new TiBase component offerings are compatible (i.e., the addition of Osstem, Thommen Medical, BioHorizons, and Dentsply Sirona Osseospeed EV and Ankylos C/X implant systems).

In addition, the format of the listing of all compatible implant systems in the indications for use has been modified in this premarket notification to provide further detailed information regarding the specific implant system name, implant platform size, and diameter for each of the compatible implant systems. This clarification to the compatibility list has been made to conform to current indications for use for clear identification of compatible implant systems.

The new "chairside" CAD/CAM software version, CEREC SW version 4.6.1 includes the introduction of revised software controls over the limitation of critical geometric parameters in the design of the mesostructure component of two-piece, "CAD/CAM" dental abutments.

Summary comparison of the intended use, indications for use, and design of the modified Sirona Dental CAD/CAM System and the predicate Sirona Dental CAD/CAM System cleared under K111421 is presented in Tables 6.1 and 6.2.

11

| Modified Device
Sirona Dental CAD/CAM System | | | Predicate Device
Sirona Dental CAD/CAM System (K111421) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 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: | | | 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
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 | Platform | Diameter | Manufacturer |
| Nobel Biocare | Replace | NP | 3.5 | • Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562) |
| | | RP | 4.3 | • Friadent Xive (K013867) |
| | | WP | 5.0 | • Biomet 3i Osseotite (K980549) |
| | | 6.0 | 6.0 | • Astra Tech Osseospeed (K091239) |
| | Active | NP | 3.5 | • Zimmer Tapered Screw-Vent (K061410) |
| | | RP | 4.3/5.0 | • Straumann SynOcta (K061176) |
| | Branemark | NP | 3.3 | • Straumann Bone Level (K053088, K062129, K060958) |
| | | RP | 3.75/4.0 | • Biomet 3i Certain (K014235, K061629) |
| | Synocta | NN (3.5mm) | 3.3 | • Nobel Biocare Active (K071370) |
| Straumann | | RN (4.8mm) | 3.3/4.1/4.8 | |
| | | 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 | Xive | 3.4 | 3.4 | |
| | | 3.8 | 3.8 | |
| | | 4.5 | 4.5 | |
| Indications for Use (continued) | | | | |
| Manufacturer | 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 | |
| Biomet 3i | Osseotite | 3.4 | 3.25 | |
| | | | 3.75 | |
| | | 4.1 | 4.1 | |
| | | | | |
| | | Certain | 5.0 | |
| | | | | |
| | | | 3.4 | |
| | | | 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 | |
| Manufacturer | Implant System | Implant Size | | |
| | | Platform | Diameter | |
| 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
Hiossen | Mini | 3.5 | |
| | 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 internal | 3.0 | 3.0 | |
| | Tapered plus | | 4.6 | |
| BioHorizons
(Internal
Connection) | 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 | | 5.8 | |
| | Internal dental implant, Single
stage dental implants | 5.7 | 5.0/6.0 | |

5.5

5.5

12

Table 6.1: Indications for Use (continued)

Modified Device

Sirona Dental CAD/CAM System

Predicate Device Sirona Dental CAD/CAM System (K111421)

13

Modified Device

Sirona Dental CAD/CAM System

Indications for Use (continued)

Predicate Device

Sirona Dental CAD/CAM System (K111421)

14

Table 6.2: Design

| Modified Device
Sirona Dental CAD/CAM System | Primary Predicate Device
Sirona Dental CAD/CAM System
(K111421) |
|-------------------------------------------------|-----------------------------------------------------------------------|
| CAD/CAM Software Version | |
| CEREC SW version 4.6.1 | CEREC SW version 4.0 |
| Acquisition Units | |
| CEREC AC | CEREC AC |
| CEREC AC Connect | CEREC AC Connect |
| CEREC Omnicam 3D digital intraoral scanner | CEREC Omnicam 3D digital intraoral scanner |
| Milling Unit | |
| CEREC MC | CEREC MC |
| CEREC MC X | CEREC MC X |
| CEREC MC XL | CEREC MC XL |
| CEREC MC XL Premium | CEREC MC XL Premium |
| Titanium Base Components | |
| Sirona TiBase | Sirona TiBase |
| Diameter: 3.0 mm – 7.0 mm | Diameter: 3.3 mm – 6.0 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 1: 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).

15

  • 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).
  • . Dynamic fatigue testing of new TiBase variants in worst-case construct according to ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants).
  • Compatibility analyses of new TiBase interface geometries with original . manufacturer's implant connection geometries. Compatibility analysis consisted of reverse engineering on OEM implant body, OEM implant abutment, and OEM implant screw, or by manufacturing agreement.
  • System validation testing conducted to confirm the design and fabrication workflow of . the "chairside" CAD/CAM software, CEREC SW version 4.6.1, with the defined scanning, acquisition, and milling equipment.
  • . New TiBase variants are composed of the identical materials and are fabricated utilizing the same methods as the components cleared under K111421. Therefore, no new biocompatibility data is included to support the substantial equivalence of the modified Sirona Dental CAD/CAM System.
  • Recommended parameters for the steam sterilization of the subject TiBase components . have been validated according to EN ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and with reference to ANSVAAMI ST79:2010 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities).
  • The subject TiBase components are provided non-sterilized by the end . user. They are composed of the identical titanium alloy material and are provided in the same packaging configuration as the predicate TiBase components cleared under K11142. No shelf life testing was included to support substantial equivalence.

Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the "chairside" CAD/CAM software, CEREC SW version 4.6.1. Software verification and validation testing was conducted to demonstrate that the 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.

16

8. Clinical Performance Data

No human clinical data was included in this premarket notification to support the substantial equivalence of the modified Sirona Dental CAD/CAM System.

9. Conclusion Regarding Substantial Equivalence

The information included in this premarket notification supports the substantial equivalence of the modified Sirona Dental CAD/CAM System. The modified device which is the subject of this premarket notification has the identical intended use as the legally marketed predicate device cleared under premarket notification K111421. The modified device also has similar indications for use and incorporates the same fundamental technology as the predicate device (K111421).

Performance and software validation data are included in this premarket notification to demonstrate the performance of the modified Sirona Dental CAD/CAM System against its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.