IPS e.max CAD Abutment Solutions- extra systems

K191382 · Ivoclar Vivadent, AG · NHA · Aug 26, 2019 · Dental

Device Facts

• Record ID: K191382
• Device Name: IPS e.max CAD Abutment Solutions- extra systems
• Applicant: Ivoclar Vivadent, AG
• Product Code: NHA · Dental
• Decision Date: Aug 26, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - IPS e.max CAD ceramic structure - Ti base - CAD/CAM system. The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems: - Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867) - BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429), - Osstem: TS Implant System (K121585) - Straumann: Tissue Level RN/WN (K061176) - Nobel Biocare: Branemark (K022562) - Zimmer: Tapered Screw-Vent (K061410) - Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991) - CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520) -Titanium Bases:

Device Story

System comprises lithium disilicate ceramic structure, titanium base (TiBase), and CAD/CAM software. Clinical situation digitalized via intraoral or model scan; CAD/CAM system designs and mills ceramic structure. Ceramic structure extraorally cemented to TiBase using adhesive; two-piece assembly fixed to implant with screw. Used in dental clinics by dentists/technicians. Provides esthetic, patient-specific abutment for single-tooth restorations. Benefits include restoration of function and esthetics in edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing performed per ISO 14801:2007 to validate compatibility with 11 additional implant systems. All other non-clinical testing leveraged from predicate/reference devices.

Technological Characteristics

Lithium disilicate ceramic blocks; titanium base (TiBase) components. Abutment angle 0°-20°. Single-use, non-sterile (steam sterilized). CAD/CAM design/milling. Compatible with specific implant systems (Dentsply Sirona, BioHorizons, Osstem, Straumann, Nobel Biocare, Zimmer, Camlog).

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations using two-piece hybrid abutments or hybrid abutment crowns in conjunction with 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

• IPS e.max® CAD Abutment Solutions (K132209)

Reference Devices

• Sirona CAD/CAM System (K100152)
• Sirona Dental CAD/CAM System (K111421)
• Sirona Dental CAD/CAM System (K181520)

Submission Summary (Full Text)

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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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

August 26, 2019

Ivoclar Vivadent, AG % Lori Aleshin Director of Quality and Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228

Re: K191382

Trade/Device Name: IPS e.max® CAD Abutment Solutions- extra systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: July 22, 2019 Received: July 24, 2019

Dear Lori Aleshin:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

#### K191382

Device Name IPS e.max® CAD Abutment Solutions- extra systems

Indications for Use (Describe)

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

- IPS e.max CAD ceramic structure
- Ti base
- CAD/CAM system.

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems:

- Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)
- BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),
- Osstem: TS Implant System (K121585)
- Straumann: Tissue Level RN/WN (K061176)
- Nobel Biocare: Branemark (K022562)
- Zimmer: Tapered Screw-Vent (K061410)
- Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)

- CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)

-Titanium Bases:

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### Dentsply Sirona TiBase

| Implant<br>manufacturer | Implant System | Implant Size<br>Diameter (mm) | Implant Size<br>Platform (mm) | TiBase | Dentsply<br>Sirona Ref. | Interface<br>size |
|--------------------------|---------------------------------|-------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|-------------------------|-------------------|
| | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S |
| Dentsply Sirona | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | |
| | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L |
| | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | |
| | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/ 4.0 S | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | |
| | AstraTech Osseospeed TX 4.5/5.0 | 4.5/ 5.0/ 5.0 S | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L |
| Dentsply Sirona | Frialit/ Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | |
| | Frialit/ Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | S |
| | Frialit/ Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | |
| | Frialit/ Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L |
| | internal connection 3.0 | 3.0 /3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| BioHorizons | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | |
| | internal connection 4.5 | 4.0/ 4.6/ 5.0/ 5.8 | 4.5 | BH 4.5 L | 6532951 | L |
| | internal connection 5.7 | 5.0/ 5.8/ 6.0 | 5.7 | BH 5.7 L | 6536242 | |
| | Nobel<br>Biocare | Brånemark' NP | 3.3 | NP | NB B 3.4 L | 6282516 |
| Brånemark' RP | | 3.75/ 4.0 | RP | NB B 4.1 L | 6282524 | L |
| Osstem<br>(USA: Hiossen) | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | |
| | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L |
| Straumann | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | |
| | Tissue Level WN | 6.5 | WM (6.5) | S.SO 6.5 L | 6284256 | |
| Zimmer | Tapered Screw-Vent 3.5 | 3.7/ 4.1 | 3.5 | Z TSV 3.5 L | 6282581 | |
| | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | L |
| | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | |
| Implant<br>manufacturer | Implant System | Implant<br>Size<br>Diameter<br>(mm) | Implant<br>Size<br>Platform<br>(mm) | TiBase | Camlog<br>Ref. | Interface<br>size |
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base<br>CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base<br>CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base<br>CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base<br>CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base<br>CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base<br>CAD/CAM, for Ø 3.3 mm, GH<br>0.8 mm | C2242.3308 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base<br>CAD/CAM, for Ø 3.3 mm, GH<br>2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base<br>CAD/CAM, for Ø 3.8 mm, GH<br>0.8 mm | C2242.3808 | S |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base<br>CAD/CAM, for Ø 3.8 mm, GH<br>2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base<br>CAD/CAM, for Ø 4.3 mm, GH<br>0.8 mm | C2242.4308 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base<br>CAD/CAM, for Ø 4.3 mm, GH<br>2.0 mm | C2242.4320 | |
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base<br>CAD/CAM, for Ø 5.0 mm, GH<br>0.8 mm | C2242.5008 | | |
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base<br>CAD/CAM, for Ø 5.0 mm, GH<br>2.0 mm | C2242.5020 | L | |
| iSy 3.8 / 4.4 / 5.0 | 3.8/<br>4.0/<br>5.0 | 3.8/<br>4.4/<br>5.0 | iSy Titanium base CAD/CAM, Ø<br>4.5 mm, GH 0.8 mm | P2244.4408 | S | |
| | | | iSy Titanium base CAD/CAM, Ø<br>4.5 mm, GH 2.0 mm | P2244.4420 | | |
| | | | iSy Titanium base CAD/CAM, Ø<br>5.2 mm, GH 0.8 mm | P2244.5008 | L | |
| | | | iSy Titanium base CAD/CAM, Ø<br>5.2 mm, GH 2.0 mm | P2244.5020 | | |

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#### Camlog TiBase

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, with the words "Ivoclar Vivadent" in a stylized font. Above the words are a series of green and blue dots and squares. Below the words is the tagline "passion vision innovation" in red.

### IPS e.max® CAD Abutment Solutions- extra systems- K191382

| Contact: | Lori Aleshin, Director of Quality and Regulatory Affairs<br>Ivoclar Vivadent, Inc.<br>175 Pineview Drive<br>Amherst, New York 14228<br>716-264-2045<br>[e-mail] | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Company: | Ivoclar Vivadent, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>[phone] | | | |
| Date Prepared: | August 26, 2019 | | | |
| Proprietary Name: | IPS e.max® CAD Abutment Solutions- extra<br>systems | | | |
| Primary Classification Name: | Abutment, Implant, Dental Endosseus (872.3630)<br>(Classification Code NHA) | | | |
| Secondary Classification Name: | Dental Abutment Design Software for Dental Laboratory<br>(872.3630) (Classification Code PNP) | | | |
| Predicate/Reference Devices: | IPS e.max® CAD Abutment Solutions (K132209) by<br>Ivoclar Vivadent, AG<br>K100152 Sirona CAD/CAM System (Reference)<br>K111421 Sirona Dental CAD/CAM System (Reference)<br>K181520 Sirona Dental CAD/CAM System (Reference) | | | |

The IPS e.max® CAD Abutment Solutions- extra systems Device Description: which is the subject of this premarket notification is a modification to the IPS e.max CAD Abutment Solutions as previously cleared under K132209. The modifications represented in the subject device consist of the addition of 11 extra Ti-Bases to the 4 previously cleared Ti-Base compatibilities.

IPS e.max CAD Abutment Solutions- extra systems is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. IPS e.max CAD Abutment Solutions is a system comprising IPS e.max CAD ceramic structure, Sirona TiBase and Sirona CAD/CAM System to design and fabricate the ceramic structure. The abutments being two-piece titanium base abutments are mated with a ceramic top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.

For the fabrication of IPS e.max CAD Abutment Solutions and depending on the CAD/CAM system used, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan. Updated material and TiBase library datasets relating to Sirona Dental CAD/CAM System with CEREC chairside software are obtained by download at: https://my.cerec.com.

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Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in blue, with the words "passion vision innovation" written in smaller letters below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape. The logo is simple and modern, with a focus on the company's name and values.

For detailed information regarding the use of Sirona Dental CAD/CAM System with CEREC chairside software, please refer to the CAD/CAM system's manual provided by Dentsply Sirona.

| Existing Implant Systems<br>(K132209) |
|---------------------------------------|
| Certain |
| Replace |
| Nobel Active |
| Bone Level |

| Extra Implant Systems |
|----------------------------------|
| AstraTech Osseospeed EV 3.6 |
| AstraTech Osseospeed EV 4.2 |
| AstraTech Osseospeed EV 4.8 |
| AstraTech Osseospeed EV 5.4 |
| AstraTech Osseospeed TX 3.5/4.0 |
| AstraTech Osseospeed TX 4.5/ 5.0 |
| Frialit/ Xive 3.4 |
| Frialit/ Xive 3.8 |
| Frialit/ Xive 4.5 |
| Frialit/ Xive 5.5 |
| internal connection 3.0 |
| internal connection 3.5 |
| internal connection 4.5 |
| internal connection 5.7 |
| Branemark® NP |
| Branemark® RP |
| Osstem TS Mini |
| Osstem TS Standard |
| Tissue Level RN |
| Tissue Level WN |
| Tapered Screw-Vent 3.5 |
| Tapered Screw-Vent 4.5 |
| Tapered Screw-Vent 5.7 |
| Camlog Screw-Line 3.3 |
| Camlog Screw-Line 3.8 |
| Camlog Screw-Line 4.3 |
| Camlog Screw-Line 5.0 |
| Camlog Screw-Line 6.0 |
| Conelog Screw-Line 3.3 |
| Conelog Screw-Line 3.8 |
| Conelog Screw-Line 4.3 |
| Conelog Screw-Line 5.0 |
| iSy 3.8 |
| iSv 4.4 |
| iSy 5.0 |

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Image /page/8/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the word "Ivoclar" stacked on top of "Vivadent". Above the company name is a semi-circle of green and blue dots. Below the company name is the slogan "passion vision innovation" in a smaller font.

Predicate Device: The primary predicate devices to which IPS e.max® CAD Abu Solutions- extra systems has been compared is Ivoclar Vivadent, AG IPS e.max® CAD Abutment Solutions (K132209).

For this application, IPS e.max® CAD Abutment Solutions- extra systems has been compared to its predicate and found equivalent with regard to the contraindications, biocompatibility, storage, technology and device specification, classification, and storage. The comparison shows that

IPS e.max® CAD Abutment Solutions- extra systems is substantially equivalent to the predicate device.

The indications and working principle only differ in the fact, that IPS e.max CAD Abutment Solutions can now be used with 11 extra systems in addition to the predicate devices 4 implant systems (i.e., Replace, Nobel Active, Bone Level, Certain).

The fatigue testing performed for the listed extra systems proves that IPS e.max CAD Abutment Solutions can be used with the 11 additional implant systems.

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Image /page/9/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in a blue, sans-serif font, with the word "Ivoclar" stacked on top of "Vivadent." Above the company name is a curved line of green and blue dots. Below the company name is the company's slogan, "passion vision innovation."

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| Technological<br>Characteristics | Proposed Device:<br>IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | Primary Predicate Device:<br>IPS e.max® CAD Abutment<br>Solutions (K132209) | Reference<br>Device: | Reference<br>Device: | Reference<br>Device: |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ivoclar Vivadent, AG | Ivoclar Vivadent, AG | Dentsply Sirona | | |
| Indications for<br>Use<br>(summarized) | IPS e.max CAD Abutment<br>Solutions is intended for use in<br>partially of fully edentulous<br>mandibles and maxillae in support<br>of single cement-retained<br>restorations.<br>The system comprises three parts:<br>- IPS e.max CAD ceramic structure<br>- Ti base and<br>- CAD/CAM software | IPS e.max CAD Abutment<br>Solutions is intended for use in<br>partially of fully edentulous<br>mandibles and maxillae in support<br>of single cement-retained<br>restorations.<br>The system comprises three parts:<br>- IPS e.max CAD ceramic structure<br>- Ti base and<br>- CAD/CAM software | The Sirona Dental CAD/CAM System is intended for use in<br>partially or fully edentulous mandibles and maxillae in<br>support of single or multiple unit cement retained<br>restorations. The system consists of three major parts:<br>TiBase, InCoris mesostructure, and CAD/CAM software. | | |
| Compatibility | The IPS e.max CAD mesostructured<br>and TiBase two-piece abutment is<br>compatible with the following<br>Implant Systems:<br>- Dentsply Sirona:<br>AstraTech OsseoSpeed,<br>Frialit/Xive (K130999, K013867)<br>- BioHorizons Implant System:<br>Internal Connection (K143022,<br>K071638, K093321, K042429),<br>- Osstem: TS Implant System<br>(K121585)<br>- Straumann: Tissue Level RN/WN<br>(K061176)<br>- Nobel Biocare: Branemark<br>(K022562) | The IPS e.max CAD mesostructured<br>and TiBase two-piece abutment is<br>compatible with the following<br>Implant Systems:<br>Certain (K014235)<br>Nobel Biocare Replace (K020646)<br>Nobel Biocare Activem (K071370)<br>Straumann Bone Level (K053088 | The InCoris<br>mesostructured and<br>TiBase two-piece<br>abutment is<br>compatible with the<br>following implant<br>systems:<br>Nobel Biocare:<br>Replace (K020646) | The InCoris<br>mesostructured and<br>TiBase two-piece<br>abutment is<br>compatible with the<br>following implant<br>systems:<br>Nobel Biocare<br>Replace (K020646) | The InCoris<br>mesostructured and<br>TiBase two-piece<br>abutment is<br>compatible with the<br>following implant<br>systems:<br>Nobel Biocare<br>Replace (K020646)<br>Nobel Biocare<br>Active (K071370) |
| Technological<br>Characteristics | Proposed Device: | Primary Predicate Device: | Reference<br>Device: | Reference<br>Device: | Reference<br>Device: |
| | IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | IPS e.max® CAD Abutment<br>Solutions (K132209) | Sirona CAD/<br>CAM System<br>(K100152) | Sirona Dental<br>CAD/CAM<br>System<br>(K111421) | Sirona Dental<br>CAD/CAM<br>System<br>(K181520) |
| | - Zimmer: Tapered Screw-Vent<br>(K061410)<br>- Camlog: Camlog Screw-Line,<br>Conelog Screw-Line, iSy<br>(K083496, K113779, K133991) | | Nobel Biocare:<br>Branemark<br>(K022562)<br>Friadent Xive<br>(K013867)<br>Biomet 3i Osseotite<br>(K980549)<br>AstraTech<br>Osseospeed<br>(K091239)<br>Zimmer Tapered<br>Screw-Vent<br>(K061410)<br>Straumann SynOcta<br>(K061176) | Nobel Biocare<br>Branemark<br>(K022562)<br>Friadent Xive<br>(K013867)<br>Biomet 3i Osseotite<br>(K980549)<br>AstraTech<br>Osseospeed<br>(K091239)<br>Zimmer Tapered<br>Screw-Vent<br>(K061410)<br>Straumann SynOcta<br>(K061176)<br>Straumann Bone<br>Level (K053088,<br>K062129, K060958) | Nobel Biocare<br>Branemark<br>(K022562)<br>Straumann SynOcta<br>(K061176)<br>Straumann Bone<br>Level (K053088,<br>K062129, K060958)<br>Dentsply Sirona<br>Osseospeed<br>(K091239)<br>Xive (K013867)<br>Dentsply Sirona<br>Osseospeed EV<br>(K130999)<br>Dentsply Sirona<br>Ankylos (K140347,<br>K083805) |
| Technological<br>Characteristics | Proposed Device:<br>IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | Primary Predicate Device:<br>IPS e.max® CAD Abutment<br>Solutions (K132209) | Reference<br>Device:<br>Sirona CAD/<br>CAM System<br>(K100152) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K111421) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K181520) |
| | | | | Biomet 3i Certain<br>(K014235,<br>K061629)<br>Nobel Biocare<br>Active (K071370) | Biomet 3i Osseotite<br>(K980549)<br>Biomet 3i Certain<br>(K014235,<br>K061629)<br>Zimmer Tapered<br>Screw-Vent<br>(K061410)<br>Thomenn Medical<br>SPI (K093615,<br>K090154)<br>Osstem/Hiossen<br>Osstem TS/<br>Hiossen (K121585,<br>K140934, K101096)<br>BioHorizons Internal<br>Connections<br>(K143022,<br>K071638, K093321,<br>K04249) |

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Image /page/10/Picture/1 description: The image contains the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "ivoclar" stacked above "vivadent". A series of green and blue squares and circles are arranged in an arc above the company name. Below the company name is the company's slogan: passion, vision, innovation.

assion vision innovation

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Image /page/11/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is in a larger, bold, blue font above the word "vivadent" which is also in blue. Above the words is an arc of green and blue dots.

passion vision innovation

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Image /page/12/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "ivoclar" in a darker blue and "vivadent" in a lighter blue. Above the company name is a semi-circular arrangement of green and blue squares, creating a visual arc. Below the company name is the tagline "passion vision innovation" in a smaller font.

| | passion vision innovation |
|--|---------------------------|
| | |
| | |

| Technological<br>Characteristics | Proposed Device:<br>IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | Primary Predicate Device:<br>IPS e.max® CAD Abutment<br>Solutions (K132209) | Reference<br>Device:<br>Sirona CAD/<br>CAM System<br>(K100152) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K111421) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K181520) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Design | IPS e.max CAD Abutment<br>Solutions are lithium disilicate<br>blocks in various sizes. One side<br>of the block is mounted to a<br>mandrel that will be inserted into<br>the spindle's clamping chuck of the<br>grinding machine. The connection<br>geometry to titanium bases is<br>prefabricated, i.e. already included<br>in the shipped block. The<br>connection geometry fit select<br>Titanium Bases as identified in the<br>Indications for Use. The<br>mesostructured is individually<br>designed and milled using<br>CAD/CAM Technology into the<br>shape of a hybrid abutment or<br>hybrid abutment crown. The<br>device serves as the esthetic<br>mesostructured which is extraorally<br>cemented onto a Titanium Base.<br>The two piece abutment is<br>mounted onto the implant and fixed<br>with a screw. | IPS e.max CAD Abutment<br>Solutions are lithium disilicate<br>blocks in various sizes. One side<br>of the block is mounted to a<br>mandrel that will be inserted into<br>the spindle's clamping chuck of the<br>grinding machine. The connection<br>geometry to titanium bases is<br>prefabricated, i.e. already included<br>in the shipped block. The<br>connection geometry fit select<br>Titanium Bases as identified in the<br>Indications for Use. The<br>mesostructured is individually<br>designed and milled using<br>CAD/CAM Technology into the<br>shape of a hybrid abutment or<br>hybrid abutment crown. The<br>device serves as the esthetic<br>mesostructured which is<br>extraorally cemented onto a<br>Titanium Base. The two piece<br>abutment is mounted onto the<br>implant and fixed with a screw. | The Sirona TiBase is a premanufactured prosthetic component<br>directly connected to endosseous dental implants with a screw and<br>is intended for use as an aid in prosthetic rehabilitation. | | |
| Technological<br>Characteristics | Proposed Device:<br>IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | Primary Predicate Device:<br>IPS e.max® CAD Abutment<br>Solutions (K132209) | Reference<br>Device:<br>Sirona CAD/<br>CAM System<br>(K100152) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K111421) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K181520) |
| Abutment Angle | 0° to 20° | 0° to 20° | 0° to 20° | | |
| Restoration | Single Unit | Single Unit | Single Unit, Multi-Unit | | |
| Implant<br>Compatibility | Dentsply Sirona:<br>AstraTech OsseoSpeed,<br>Frialit/Xive<br>- BioHorizons Implant System:<br>Internal Connection<br>- Osstem: TS Implant System<br>- Straumann: Tissue Level RN/WN<br>- Nobel Biocare: Branemark<br>- Zimmer: Tapered Screw-Vent<br>- Camlog:<br>Camlog Screw-Line<br>Conelog Screw-Line<br>iSy | Certain<br>Nobel Biocare Replace<br>Nobel Biocare Activem<br>Straumann Bone Level | Nobel Biocare-<br>Replace, Branemark<br>Friadent- Xive<br>Biomet 3i- Osseotite<br>Astra Tech-<br>Osseospeed<br>Zimmer- Tapered<br>Screw-Vent<br>Straumann-<br>SynOcta | Nobel Biocare-<br>Replace,<br>Branemark<br>Friadent Xive<br>Biomet 3i-<br>Osseotite, Certain<br>Astra Tech-<br>OsseoSpeed<br>Zimmer- Tapered<br>Screw-Vent<br>Straumann-<br>SynOcta, Bone<br>Level<br>Nobel Biocare-<br>Nobel Active | Nobel Biocare-<br>Replace, Active,<br>Branemark<br>Straumann-<br>SynOcta , Bone<br>Level<br>Dentsply Sirona-<br>Osseospeed, Xive,<br>Osseospeed EV,<br>Ankylos<br>Biomet 3i-<br>Osseotite, Certain<br>Zimmer- Tapered<br>Screw-Vent<br>Thomenn Medical-<br>SPI |
| Technological<br>Characteristics | Proposed Device:<br>IPS e.max CAD Abutment<br>Solutions- extra systems<br>(K191382) | Primary Predicate Device:<br>IPS e.max® CAD Abutment<br>Solutions (K132209) | Reference<br>Device:<br>Sirona CAD/<br>CAM System<br>(K100152) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K111421) | Reference<br>Device:<br>Sirona Dental<br>CAD/CAM<br>System<br>(K181520) |
| | | | | | Osstem/Hiossen-<br>Osstem TS/ Hiosse<br>BioHorizons-<br>Internal Connection |
| Block Material | Lithium Disilicate | Lithium Disilicate | InCoris | InCoris | InCoris |
| Cement<br>(Adhesive) | Multilink Hybrid Abutment | Multilink Hybrid Abutment | Panavia F2.0 | Panavia F2.0 | Panavia F2.0 |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Sterilization<br>Method | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| Use | Single Use | Single Use | Single-Use | Single-Use | Single-Use |

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Image /page/13/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "Ivoclar" is on top of the word "Vivadent". Above the words is a semi-circle of green and blue dots. Below the words is the phrase "passion vision innovation".

ovation ssion vision inn

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Image /page/14/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, and it features the company name in a stylized font. Above the company name is a semi-circle of green and blue dots. Below the company name is the slogan "passion vision innovation".

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### Indications for Use Statement:

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

- IPS e.max CAD ceramic structure
- Ti base
- CAD/CAM system.

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems:

- Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)
- BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),
- Osstem: TS Implant System (K121585)
- Straumann: Tissue Level RN/WN (K061176)
- Nobel Biocare: Branemark (K022562)
- Zimmer: Tapered Screw-Vent (K061410)
- Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)

- CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)

-Titanium Bases:

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Image /page/16/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in blue, with the words "passion vision innovation" in smaller, red font underneath. Above the company name is a series of green and blue dots that form an arc.

### Dentsply Sirona TiBase

| Implant<br>manufacturer | Implant System | Implant Size<br>Diameter (mm) | Implant Size<br>Platform…