Sirona Dental CAD/CAM System

K181520 · Dentsply Sirona · NHA · Oct 11, 2018 · Dental

Device Facts

• Record ID: K181520
• Device Name: Sirona Dental CAD/CAM System
• Applicant: Dentsply Sirona
• Product Code: NHA · Dental
• Decision Date: Oct 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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:

Device Story

System acquires 3D topographical dental data via intraoral scanner (CEREC Omnicam) and acquisition units (CEREC AC/AC Connect); software (CEREC SW 4.6.1) designs patient-specific two-piece abutments (TiBase and inCoris mesostructure); milling unit (CEREC MCXL) fabricates mesostructure from zirconium blocks; clinician cements mesostructure to TiBase using dental cement; used in dental clinics to restore oral function/aesthetics; output guides clinical restoration design; benefits include patient-specific fit and chairside workflow efficiency.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including IEC 60601-1/1-2 compliance, ISO 14801 dynamic fatigue testing of TiBase variants, compatibility analysis of interface geometries, and software verification/validation.

Technological Characteristics

System includes digital acquisition units, CAD/CAM software, and milling units. Components: Titanium alloy TiBase, zirconium mesostructure. Connectivity: Standalone chairside workflow. Sterilization: Steam sterilization (EN ISO 17665-1, ANSI/AAMI ST79). Software: CEREC SW 4.6.1 with locked design libraries and geometric parameter controls.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit cement-retained restorations. Specific titanium bases (BH 3.0 S, SSO 3.5 L, SBL 3.3 L) restricted to single lateral incisors (maxilla) and lateral/central incisors (mandible). Compatible with various endosseous dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Sirona Dental CAD/CAM System (K111421)

Reference Devices

• TS Implant System (K121585)
• Hiossen Implant System (K140934, K101096)
• SPI Element, SPI Element INICELL, SPI Contact INICELL (K093615, K090154)
• Osseospeed EV (AT EV) Implants (K130999)
• Ankylos C/X Implant System (K140347, K083805)
• BioHorizons Implant System (internal connection) (K143022, K071638, K093321, K042429)
• IPS e.max CAD Abutment Solutions (K132209)
• Telio CAD Abutment Solutions (K151564)
• VITA ENAMIC IS (K153564)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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:

| 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 |
| | 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 |
| 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 | Certain | | 3.25 |
| | | 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 |
| Thommen Medical | SPI ELEMENT, SPI<br>ELEMENT INICELL, SPI<br>CONTACT INICELL | 3.5 | 3.5 |
| | | 4 | 4 |
| | | 4.5 | 4.5 |
| | | 5 | 5 |
| | | 6 | 6 |
| Osstem / Hiossen | Osstem TS Implant System<br>Hiossen Implant System | Mini<br>Regular | 3.5<br>4.0/4.5/5.0/6.0/7.0 |
| Manufacturer | Name of Implant System | Implant Size | |
| | | Platform | Diameter |
| BioHorizons<br>(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<br>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<br>internal tissue level | 4.5 | 4.6 |
| | Internal dental implant | | 4.0 |
| | Single stage dental implants | | 4.0/5.0 |
| | Tapered internal, Tapered<br>internal tissue level | 5.7 | 5.8 |
| | Internal dental implant,<br>Single stage dental implants | | 5.0/6.0 |

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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

- 2. 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 Device | 510(k) | Company Name |
|------------------------------|---------|----------------------------|
| Sirona Dental CAD/CAM System | K111421 | Sirona Dental Systems GmbH |

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Reference Devices:

| Reference Device | Manufacturer | 510(k) Clearance |
|-------------------------------------------------------------|---------------------------------------|---------------------------------------|
| TS Implant System | Osstem Implant Co., Ltd. | K121585 |
| Hiossen Implant System | Hiossen, Inc. | K140934, K101096 |
| SPI Element, SPI Element<br>INICELL, SPI Contact<br>INICELL | Thommen Medical AG | K093615, K090154 |
| Osseospeed EV (AT EV)<br>Implants | Dentsply Sirona Implants | K130999 |
| Ankylos C/X Implant System | Dentsply Sirona Implants | K140347, K083805 |
| BioHorizons Implant System<br>(internal connection) | BioHorizons Implant Systems,<br>Inc. | K143022, K071638, K093321,<br>K042429 |
| IPS e.max CAD Abutment<br>Solutions | Ivoclar Vivadent AG | K132209 |
| Telio CAD Abutment Solutions | Ivoclar Vivadent AG | K151564 |
| VITA ENAMIC IS | Vita Zahnfabrik H. Rauter<br>GmbH Co. | K153564 |

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#### 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.

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#### 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:

| Manufacturer | Name of Implant System | Implant Size | |
|--------------------------------------|----------------------------------------------------------|-----------------|---------------------|
| | | Platform | Diameter |
| | 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 |
| | Branemark | NP | 3.3 |
| | | RP | 3.75/4.0 |
| | Synocta | NN (3.5mm) | 3.3 |
| | | RN (4.8mm) | 3.3/4.1/4.8 |
| Straumann | | WN (6.5mm) | 4.8 |
| | Bone Level | NC (3.3mm) | 3.3 |
| | | RC (4.1mm/4.8mm | 4.1/4.8 |
| | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S |
| | | 4.5/5.0 | 4.5/5.0/5.0 S |
| | Xive | 3.4 | 3.4 |
| | | 3.8 | 3.8 |
| | | 4.5 | 4.5 |
| Dentsply Sirona Implants | | 5.5 | 5.5 |
| | 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 |
| 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 |
| | | 3.4 | 3.25 |
| Biomet 3i | Certain | | 4/3 |
| | | | 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,<br>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 |
| | Tapered 3.0,Tapered plus | | 3.0/3.4/3.8 |
| BioHorizons<br>(Internal Connection) | Tapered internal | 3.0 | 3.0 |
| | Tapered plus | | 4.6 |
| | Tapered internal, Tapered internal tissue<br>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<br>level | 4.5 | 4.6 |
| | Internal dental implant | | 4.0 |
| | Single stage dental implants | | 4.0/5.0 |
| | Tapered internal, Tapered internal tissue<br>level | | 5.8 |
| | Internal dental implant, Single stage dental<br>implants | 5.7 | 5.0/6.0 |

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#### 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.

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| Modified Device<br>Sirona Dental CAD/CAM System | | | Predicate Device<br>Sirona Dental CAD/CAM System (K111421) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and<br>maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L<br>and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in<br>the maxilla and lateral and central incisors in the mandible. The system consists of three major parts:<br>TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and<br>TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental<br>implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructures may also be<br>used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the<br>Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris<br>mesostructure. The inCoris mesostructure and TiBase two- piece abutment is compatible with the<br>following implant systems: | | | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous<br>mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the<br>SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single<br>lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists<br>of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the<br>inCoris mesostructure and TiBase components make up a two-piece abutment which is used in<br>conjunction with endosseous dental implants to restore the function and aesthetics in the oral<br>cavity. The inCoris mesostructures may also be used in conjunction with the Camlog Titanium<br>base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM<br>software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure<br>and TiBase two- piece abutment is compatible with the following implant systems: | |
| Manufacturer | Implant<br>System | Platform | Diameter | Manufacturer |
| Nobel Biocare | Replace | NP | 3.5 | • Nobel Biocare Replace (K020646)<br>• 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<br>Implants…