Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the materials, components, and CAD/CAM fabrication process. There is no mention of AI or ML being used in the design or function of the device or the associated software.

Therapeutic

Yes

The device, IPS e.max® CAD Abutment Solutions, is a dental abutment system intended for use in supporting single cement-retained restorations in edentulous mandibles and maxillae. It is designed to be used in conjunction with endosseous dental implants to improve the function and aesthetics for patients with missing teeth, thus providing a therapeutic benefit in restoring dental function.

Diagnostic

No

This device is a dental abutment solution used for supporting single cement-retained restorations in edentulous mandibles and maxillae, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a system comprising physical components (ceramic structure, Ti base) and relies on a CAD/CAM system for fabrication, indicating it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for supporting single cement-retained restorations in the mouth (mandibles and maxillae) in conjunction with dental implants. This is a direct clinical application within the body, not a test performed on samples taken from the body.
Device Description: The description details a system for creating dental abutments and abutment crowns, which are physical components placed in the mouth. It involves CAD/CAM technology to design and mill these components.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.

The device is a medical device used for dental restoration, specifically for creating components that connect a dental implant to a crown.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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:
Dentsply Sirona TiBase (table continues on page 3)
Camlog TiBase (table continues on page 4)

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

NHA, PNP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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)

The device was designed and tested in accordance with quidance document for Root Form Endosseous Dental Implants and Abutments, May 12, 2004 and with ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This standard is recognized by the FDA under Recognition Number 4-195. All other applicable non-clinical testing is leveraged from the listed predicate/reference devices. Fatigue testing for the listed extra systems has been performed and discussed more fully in the Performance Testing- Bench (section 14) of this application.

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.

K132209

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.

K100152, K111421, K181520

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

Regulation Number and Section

§ 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.)

Summary

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 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.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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:

3

Dentsply Sirona TiBase

| Implant
manufacturer | Implant System | Implant Size
Diameter (mm) | Implant Size
Platform (mm) | TiBase | Dentsply
Sirona Ref. | Interface
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
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
(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
manufacturer | Implant System | Implant
Size
Diameter
(mm) | Implant
Size
Platform
(mm) | TiBase | Camlog
Ref. | Interface
size |
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
0.8 mm | C2242.3308 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
0.8 mm | C2242.3808 | S |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
0.8 mm | C2242.4308 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
2.0 mm | C2242.4320 | |
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
0.8 mm | C2242.5008 | | |
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
2.0 mm | C2242.5020 | L | |
| iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 0.8 mm | P2244.4408 | S | |
| | | | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 2.0 mm | P2244.4420 | | |
| | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 0.8 mm | P2244.5008 | L | |
| | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 2.0 mm | P2244.5020 | | |

4

Camlog TiBase

5

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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6

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
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-264-2045
lori.aleshin@ivoclarvivadent.com | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 2, Schaan, FL-9494, Liechtenstein
+423-235-3535 | | | |
| Date Prepared: | August 26, 2019 | | | |
| Proprietary Name: | IPS e.max® CAD Abutment Solutions- extra
systems | | | |
| Primary Classification Name: | Abutment, Implant, Dental Endosseus (872.3630)
(Classification Code NHA) | | | |
| Secondary Classification Name: | Dental Abutment Design Software for Dental Laboratory
(872.3630) (Classification Code PNP) | | | |
| Predicate/Reference Devices: | IPS e.max® CAD Abutment Solutions (K132209) by
Ivoclar Vivadent, AG
K100152 Sirona CAD/CAM System (Reference)
K111421 Sirona Dental CAD/CAM System (Reference)
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.

7

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

(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

8

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.

9

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."

ovation unn Monsty Monsse

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

10

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

11

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

12

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
Characteristics | Proposed Device:
IPS e.max CAD Abutment
Solutions- extra systems
(K191382) | Primary Predicate Device:
IPS e.max® CAD Abutment
Solutions (K132209) | Reference
Device:
Sirona CAD/
CAM System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Design | IPS e.max CAD Abutment
Solutions are lithium disilicate
blocks in various sizes. One side
of the block is mounted to a
mandrel that will be inserted into
the spindle's clamping chuck of the
grinding machine. The connection
geometry to titanium bases is
prefabricated, i.e. already included
in the shipped block. The
connection geometry fit select
Titanium Bases as identified in the
Indications for Use. The
mesostructured is individually
designed and milled using
CAD/CAM Technology into the
shape of a hybrid abutment or
hybrid abutment crown. The
device serves as the esthetic
mesostructured which is extraorally
cemented onto a Titanium Base.
The two piece abutment is
mounted onto the implant and fixed
with a screw. | IPS e.max CAD Abutment
Solutions are lithium disilicate
blocks in various sizes. One side
of the block is mounted to a
mandrel that will be inserted into
the spindle's clamping chuck of the
grinding machine. The connection
geometry to titanium bases is
prefabricated, i.e. already included
in the shipped block. The
connection geometry fit select
Titanium Bases as identified in the
Indications for Use. The
mesostructured is individually
designed and milled using
CAD/CAM Technology into the
shape of a hybrid abutment or
hybrid abutment crown. The
device serves as the esthetic
mesostructured which is
extraorally cemented onto a
Titanium Base. The two piece
abutment is mounted onto the
implant and fixed with a screw. | The Sirona TiBase is a premanufactured prosthetic component
directly connected to endosseous dental implants with a screw and
is intended for use as an aid in prosthetic rehabilitation. | | |
| Technological
Characteristics | Proposed Device:
IPS e.max CAD Abutment
Solutions- extra systems
(K191382) | Primary Predicate Device:
IPS e.max® CAD Abutment
Solutions (K132209) | Reference
Device:
Sirona CAD/
CAM System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| Abutment Angle | 0° to 20° | 0° to 20° | 0° to 20° | | |
| Restoration | Single Unit | Single Unit | Single Unit, Multi-Unit | | |
| Implant
Compatibility | Dentsply Sirona:
AstraTech OsseoSpeed,
Frialit/Xive

BioHorizons Implant System:
Internal Connection
Osstem: TS Implant System
Straumann: Tissue Level RN/WN
Nobel Biocare: Branemark
Zimmer: Tapered Screw-Vent
Camlog:
Camlog Screw-Line
Conelog Screw-Line
iSy | Certain
Nobel Biocare Replace
Nobel Biocare Activem
Straumann Bone Level | Nobel Biocare-
Replace, Branemark
Friadent- Xive
Biomet 3i- Osseotite
Astra Tech-
Osseospeed
Zimmer- Tapered
Screw-Vent
Straumann-
SynOcta | Nobel Biocare-
Replace,
Branemark
Friadent Xive
Biomet 3i-
Osseotite, Certain
Astra Tech-
OsseoSpeed
Zimmer- Tapered
Screw-Vent
Straumann-
SynOcta, Bone
Level
Nobel Biocare-
Nobel Active | Nobel Biocare-
Replace, Active,
Branemark
Straumann-
SynOcta , Bone
Level
Dentsply Sirona-
Osseospeed, Xive,
Osseospeed EV,
Ankylos
Biomet 3i-
Osseotite, Certain
Zimmer- Tapered
Screw-Vent
Thomenn Medical-
SPI |
| Technological
Characteristics | Proposed Device:
IPS e.max CAD Abutment
Solutions- extra systems
(K191382) | Primary Predicate Device:
IPS e.max® CAD Abutment
Solutions (K132209) | Reference
Device:
Sirona CAD/
CAM System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| | | | | | Osstem/Hiossen-
Osstem TS/ Hiosse
BioHorizons-
Internal Connection |
| Block Material | Lithium Disilicate | Lithium Disilicate | InCoris | InCoris | InCoris |
| Cement
(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
Method | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| Use | Single Use | Single Use | Single-Use | Single-Use | Single-Use |

13

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

14

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".

15

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:

16

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
manufacturer | Implant System Diameter (mm) | Implant Size
Platform (mm) | TiBase | Dentsply
Sirona Ref. | Interface
size |
|--------------------------|------------------- | | AstraTech Osseospeed EV 3.6 | | AstraTech Osseospeed EV 4.2 | | AstraTech Osseospeed EV 4.8 | | AstraTech Osseospeed EV 5.4 | Dentsply Sirona | AstraTech | | AstraTech | | Frialit/ Xive 3.4 | | Frialit/ Xive 3.8 | | Frialit/ Xive 4.5 | | Frialit/ Xive 5.5 | BioHorizons | internal connection 3.0 | | internal connection 3.5 | | internal connection 4.5 | | internal connection 5.7 | Nobel
Biocare | Brånemark® NP | | Brånemark® RP | Osstem
(USA: Hiossen) | Osstem TS Mini | | Osstem TS Standard | Straumann | Tissue Level RN | | Tissue Level WN | Zimmer | Tapered Screw-Vent 3.5 | | Tapered Screw-Vent 4.5 | | Tapered Screw-Vent 5.7 | Implant Size
--------------|-------------------------------|-------------------------------|-----------------|-------------------------|-------------------|
| 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S |
| 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | |
| 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L |
| 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | |
Osseospeed TX 3.5/4.0 | 3.5 S/ 4.0 S | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | |
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 |
| 3.4 | 3.4 | FX 3.4 S | 6282433 | |
| 3.8 | 3.8 | FX 3.8 S | 6282441 | S |
| 4.5 | 4.5 | FX 4.5 L | 6282458 | |
| 5.5 | 5.5 | FX 5.5 L | 6282466 | L |
| 3.0 /3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | |
| 4.0/ 4.6/ 5.0/ 5.8 | 4.5 | BH 4.5 L | 6532951 | L |
| 5.0/ 5.8/ 6.0 | 5.7 | BH 5.7 L | 6536242 | |
| 3.3 | NP | NB B 3.4 L | 6282516 | |
| 3.75/ 4.0 | RP | NB B 4.1 L | 6282524 | L |
| 3.5 | Mini | O TS 3.5 L | 6527035 | |
| 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L |
| 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | |
| 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | |
| 3.7/ 4.1 | 3.5 | Z TSV 3.5 L | 6282581 | |
| 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | |
| 6 | 5.7 | Z TSV 5.7 L | 6282607 | L |

17

Image /page/17/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in blue, with the words "passion vision innovation" in red underneath. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape.

Camlog TiBase

| Implant
manufacturer | Implant System | Implant
Size
Diameter
(mm) | Implant
Size
Platform
(mm) | TiBase | Camlog
Ref. | Interface
size |
|-------------------------|------------------------|-------------------------------------|-------------------------------------|---------------------------------------------------------------|----------------|-------------------|
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG® Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG® Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG® Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG® Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG® Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG® Titanium base
CAD/CAM, for Ø 3.3 mm, GH
0.8 mm | C2242.3308 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG® Titanium base
CAD/CAM, for Ø 3.3 mm, GH
2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG® Titanium base
CAD/CAM, for Ø 3.8 mm, GH
0.8 mm | C2242.3808 | S |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG® Titanium base
CAD/CAM, for Ø 3.8 mm, GH
2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG® Titanium base
CAD/CAM, for Ø 4.3 mm, GH
0.8 mm | C2242.4308 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG® Titanium base
CAD/CAM, for Ø 4.3 mm, GH
2.0 mm | C2242.4320 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG® Titanium base
CAD/CAM, for Ø 5.0 mm, GH
0.8 mm | C2242.5008 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG® Titanium base
CAD/CAM, for Ø 5.0 mm, GH
2.0 mm | C2242.5020 | L |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy® Titanium base CAD/CAM, Ø
4.5 mm, GH 0.8 mm | P2244.4408 | S |
| | | | | iSy® Titanium base CAD/CAM, Ø
4.5 mm, GH 2.0 mm | P2244.4420 | |
| | | | | iSy® Titanium base CAD/CAM, Ø
5.2 mm, GH 0.8 mm | P2244.5008 | |
| | | | | iSy® Titanium base CAD/CAM, Ø
5.2 mm, GH 2.0 mm | P2244.5020 | L |

18

Image /page/18/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with the words "Ivoclar" and "Vivadent" stacked on top of each other. Above the company name is a series of green dots that fade from dark to light. Below the company name is the slogan "passion vision innovation" in a smaller font.

Technoloqical Characteristics:

The device design, i.e. delivery form and composition of IPS e.max CAD Abutment Solutionsextra systems and the predicate device are the same. The indications for use of the IPS e.max CAD Abutment Solutions have been modified relative to the expansion of implant systems to which the existing TiBase component offerings are compatible (i.e., the addition of AstraTech Osseospeed, Frialit/Xive, Internal connection, Bårnemark®, Tissue Level, Tapered Screw-Vent, Camlog Screw-Line, Conelog Screw-Line, iSy, and Osstem TS). The submission is taking the previously cleared e.max CAD ceramic material and extending it's Ti-Base compatibilities to these additional Ti-Base abutments cleared under the referenced Sirona CAD/CAM System submissions.

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 names, implant platform size, and diameter for each of the compatible implant systems. This clarification to the compatibility list has been made for clear identification of compatible implant systems.

Testing Summary:

The device was designed and tested in accordance with quidance document for Root Form Endosseous Dental Implants and Abutments, May 12, 2004 and with ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This standard is recognized by the FDA under Recognition Number 4-195. All other applicable non-clinical testing is leveraged from the listed predicate/reference devices. Fatigue testing for the listed extra systems has been performed and discussed more fully in the Performance Testing- Bench (section 14) of this application.

Conclusion:

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