(95 days)
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, Camlog TiBase
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.
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 document describes the regulatory submission for the IPS e.max® CAD Abutment Solutions- extra systems (K191382). This device is a modification of a previously cleared device (K132209) and primarily focuses on the addition of new compatible titanium bases for various implant systems.
The acceptance criteria and study information are derived from the "Testing Summary" and "Conclusion" sections.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily discusses the substantial equivalence of the modified device to its predicate, focusing on adding new compatible implant systems. The primary performance characteristic assessed is fatigue strength.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Conformance with ISO 14801:2007 (Dynamic fatigue test for endosseous dental implants) | Fatigue testing performed and passed for all listed extra systems. Device determined to be substantially equivalent to predicate. |
| Conformance with guidance document for Root Form Endosseous Dental Implants and Abutments | Device designed and tested in accordance with guidance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "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." However, specific sample sizes (e.g., number of test specimens per implant system) are not explicitly provided in the provided text for the fatigue testing. The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The type of testing described (dynamic fatigue) is a bench-top mechanical test, not reliant on expert evaluation for ground truth in the traditional sense of clinical studies.
4. Adjudication Method for the Test Set:
This information is not applicable as the described testing is a bench-top mechanical fatigue test, not a clinical study involving human readers or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an endosseous dental implant abutment system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device (dental abutment system), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation in this context is based on mechanical endurance testing (fatigue strength) as defined by the ISO 14801:2007 standard.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reason as above.
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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 (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
| Implantmanufacturer | Implant System | Implant SizeDiameter (mm) | Implant SizePlatform (mm) | TiBase | DentsplySirona Ref. | Interfacesize |
|---|---|---|---|---|---|---|
| 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 | ||
| NobelBiocare | 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 | ||
| Implantmanufacturer | Implant System | ImplantSizeDiameter(mm) | ImplantSizePlatform(mm) | TiBase | CamlogRef. | Interfacesize |
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium baseCAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium baseCAD/CAM, for Ø 3.8 mm | K2244.3848 | S | |
| Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium baseCAD/CAM, for Ø 4.3 mm | K2244.4348 | ||
| Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium baseCAD/CAM, for Ø 5.0 mm | K2244.5048 | L | |
| Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium baseCAD/CAM, for Ø 6.0 mm | K2244.6048 | ||
| Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium baseCAD/CAM, for Ø 3.3 mm, GH0.8 mm | C2242.3308 | ||
| Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium baseCAD/CAM, for Ø 3.3 mm, GH2.0 mm | C2242.3320 | ||
| Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium baseCAD/CAM, for Ø 3.8 mm, GH0.8 mm | C2242.3808 | S | |
| Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium baseCAD/CAM, for Ø 3.8 mm, GH2.0 mm | C2242.3820 | ||
| Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium baseCAD/CAM, for Ø 4.3 mm, GH0.8 mm | C2242.4308 | ||
| Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium baseCAD/CAM, for Ø 4.3 mm, GH2.0 mm | C2242.4320 | ||
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium baseCAD/CAM, for Ø 5.0 mm, GH0.8 mm | C2242.5008 | ||
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium baseCAD/CAM, for Ø 5.0 mm, GH2.0 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, Ø4.5 mm, GH 0.8 mm | P2244.4408 | S | |
| iSy Titanium base CAD/CAM, Ø4.5 mm, GH 2.0 mm | P2244.4420 | |||||
| iSy Titanium base CAD/CAM, Ø5.2 mm, GH 0.8 mm | P2244.5008 | L | ||||
| iSy Titanium base CAD/CAM, Ø5.2 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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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 AffairsIvoclar Vivadent, Inc.175 Pineview DriveAmherst, New York 14228716-264-2045lori.aleshin@ivoclarvivadent.com | |||
|---|---|---|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535 | |||
| Date Prepared: | August 26, 2019 | |||
| Proprietary Name: | IPS e.max® CAD Abutment Solutions- extrasystems | |||
| 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) byIvoclar Vivadent, AGK100152 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
| TechnologicalCharacteristics | Proposed Device:IPS e.max CAD AbutmentSolutions- extra systems(K191382) | Primary Predicate Device:IPS e.max® CAD AbutmentSolutions (K132209) | ReferenceDevice: | ReferenceDevice: | ReferenceDevice: |
|---|---|---|---|---|---|
| Manufacturer | Ivoclar Vivadent, AG | Ivoclar Vivadent, AG | Dentsply Sirona | ||
| Indications forUse(summarized) | IPS e.max CAD AbutmentSolutions is intended for use inpartially of fully edentulousmandibles and maxillae in supportof single cement-retainedrestorations.The system comprises three parts:- IPS e.max CAD ceramic structure- Ti base and- CAD/CAM software | IPS e.max CAD AbutmentSolutions is intended for use inpartially of fully edentulousmandibles and maxillae in supportof single cement-retainedrestorations.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 inpartially or fully edentulous mandibles and maxillae insupport of single or multiple unit cement retainedrestorations. The system consists of three major parts:TiBase, InCoris mesostructure, and CAD/CAM software. | ||
| Compatibility | The IPS e.max CAD mesostructuredand TiBase two-piece abutment iscompatible with the followingImplant 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 mesostructuredand TiBase two-piece abutment iscompatible with the followingImplant Systems:Certain (K014235)Nobel Biocare Replace (K020646)Nobel Biocare Activem (K071370)Straumann Bone Level (K053088 | The InCorismesostructured andTiBase two-pieceabutment iscompatible with thefollowing implantsystems:Nobel Biocare:Replace (K020646) | The InCorismesostructured andTiBase two-pieceabutment iscompatible with thefollowing implantsystems:Nobel BiocareReplace (K020646) | The InCorismesostructured andTiBase two-pieceabutment iscompatible with thefollowing implantsystems:Nobel BiocareReplace (K020646)Nobel BiocareActive (K071370) |
| TechnologicalCharacteristics | Proposed Device: | Primary Predicate Device: | ReferenceDevice: | ReferenceDevice: | ReferenceDevice: |
| IPS e.max CAD AbutmentSolutions- extra systems(K191382) | IPS e.max® CAD AbutmentSolutions (K132209) | Sirona CAD/CAM System(K100152) | Sirona DentalCAD/CAMSystem(K111421) | Sirona DentalCAD/CAMSystem(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)AstraTechOsseospeed(K091239)Zimmer TaperedScrew-Vent(K061410)Straumann SynOcta(K061176) | Nobel BiocareBranemark(K022562)Friadent Xive(K013867)Biomet 3i Osseotite(K980549)AstraTechOsseospeed(K091239)Zimmer TaperedScrew-Vent(K061410)Straumann SynOcta(K061176)Straumann BoneLevel (K053088,K062129, K060958) | Nobel BiocareBranemark(K022562)Straumann SynOcta(K061176)Straumann BoneLevel (K053088,K062129, K060958)Dentsply SironaOsseospeed(K091239)Xive (K013867)Dentsply SironaOsseospeed EV(K130999)Dentsply SironaAnkylos (K140347,K083805) | ||
| TechnologicalCharacteristics | Proposed Device:IPS e.max CAD AbutmentSolutions- extra systems(K191382) | Primary Predicate Device:IPS e.max® CAD AbutmentSolutions (K132209) | ReferenceDevice:Sirona CAD/CAM System(K100152) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K111421) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K181520) |
| Biomet 3i Certain(K014235,K061629)Nobel BiocareActive (K071370) | Biomet 3i Osseotite(K980549)Biomet 3i Certain(K014235,K061629)Zimmer TaperedScrew-Vent(K061410)Thomenn MedicalSPI (K093615,K090154)Osstem/HiossenOsstem TS/Hiossen (K121585,K140934, K101096)BioHorizons InternalConnections(K143022,K071638, K093321,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 | |
|---|---|
| TechnologicalCharacteristics | Proposed Device:IPS e.max CAD AbutmentSolutions- extra systems(K191382) | Primary Predicate Device:IPS e.max® CAD AbutmentSolutions (K132209) | ReferenceDevice:Sirona CAD/CAM System(K100152) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K111421) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K181520) |
|---|---|---|---|---|---|
| General Design | IPS e.max CAD AbutmentSolutions are lithium disilicateblocks in various sizes. One sideof the block is mounted to amandrel that will be inserted intothe spindle's clamping chuck of thegrinding machine. The connectiongeometry to titanium bases isprefabricated, i.e. already includedin the shipped block. Theconnection geometry fit selectTitanium Bases as identified in theIndications for Use. Themesostructured is individuallydesigned and milled usingCAD/CAM Technology into theshape of a hybrid abutment orhybrid abutment crown. Thedevice serves as the estheticmesostructured which is extraorallycemented onto a Titanium Base.The two piece abutment ismounted onto the implant and fixedwith a screw. | IPS e.max CAD AbutmentSolutions are lithium disilicateblocks in various sizes. One sideof the block is mounted to amandrel that will be inserted intothe spindle's clamping chuck of thegrinding machine. The connectiongeometry to titanium bases isprefabricated, i.e. already includedin the shipped block. Theconnection geometry fit selectTitanium Bases as identified in theIndications for Use. Themesostructured is individuallydesigned and milled usingCAD/CAM Technology into theshape of a hybrid abutment orhybrid abutment crown. Thedevice serves as the estheticmesostructured which isextraorally cemented onto aTitanium Base. The two pieceabutment is mounted onto theimplant and fixed with a screw. | The Sirona TiBase is a premanufactured prosthetic componentdirectly connected to endosseous dental implants with a screw andis intended for use as an aid in prosthetic rehabilitation. | ||
| TechnologicalCharacteristics | Proposed Device:IPS e.max CAD AbutmentSolutions- extra systems(K191382) | Primary Predicate Device:IPS e.max® CAD AbutmentSolutions (K132209) | ReferenceDevice:Sirona CAD/CAM System(K100152) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K111421) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K181520) |
| Abutment Angle | 0° to 20° | 0° to 20° | 0° to 20° | ||
| Restoration | Single Unit | Single Unit | Single Unit, Multi-Unit | ||
| ImplantCompatibility | 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-LineConelog Screw-LineiSy | CertainNobel Biocare ReplaceNobel Biocare ActivemStraumann Bone Level | Nobel Biocare-Replace, BranemarkFriadent- XiveBiomet 3i- OsseotiteAstra Tech-OsseospeedZimmer- TaperedScrew-VentStraumann-SynOcta | Nobel Biocare-Replace,BranemarkFriadent XiveBiomet 3i-Osseotite, CertainAstra Tech-OsseoSpeedZimmer- TaperedScrew-VentStraumann-SynOcta, BoneLevelNobel Biocare-Nobel Active | Nobel Biocare-Replace, Active,BranemarkStraumann-SynOcta , BoneLevelDentsply Sirona-Osseospeed, Xive,Osseospeed EV,AnkylosBiomet 3i-Osseotite, CertainZimmer- TaperedScrew-VentThomenn Medical-SPI |
| TechnologicalCharacteristics | Proposed Device:IPS e.max CAD AbutmentSolutions- extra systems(K191382) | Primary Predicate Device:IPS e.max® CAD AbutmentSolutions (K132209) | ReferenceDevice:Sirona CAD/CAM System(K100152) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K111421) | ReferenceDevice:Sirona DentalCAD/CAMSystem(K181520) |
| Osstem/Hiossen-Osstem TS/ HiosseBioHorizons-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 |
| SterilizationMethod | 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
{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".
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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
| Implantmanufacturer | Implant System | Implant SizeDiameter (mm) | Implant SizePlatform (mm) | TiBase | DentsplySirona Ref. | Interfacesize |
|---|---|---|---|---|---|---|
| AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S | |
| 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 | ||
| Dentsply Sirona | 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 | |
| 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 | |
| BioHorizons | internal connection 3.0 | 3.0 /3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| 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 | ||
| NobelBiocare | 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 | ||
| Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | L |
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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
| Implantmanufacturer | Implant System | ImplantSizeDiameter(mm) | ImplantSizePlatform(mm) | TiBase | CamlogRef. | Interfacesize |
|---|---|---|---|---|---|---|
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG® Titanium baseCAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG® Titanium baseCAD/CAM, for Ø 3.8 mm | K2244.3848 | S | |
| Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG® Titanium baseCAD/CAM, for Ø 4.3 mm | K2244.4348 | ||
| Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG® Titanium baseCAD/CAM, for Ø 5.0 mm | K2244.5048 | L | |
| Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG® Titanium baseCAD/CAM, for Ø 6.0 mm | K2244.6048 | ||
| Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG® Titanium baseCAD/CAM, for Ø 3.3 mm, GH0.8 mm | C2242.3308 | ||
| Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG® Titanium baseCAD/CAM, for Ø 3.3 mm, GH2.0 mm | C2242.3320 | ||
| Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG® Titanium baseCAD/CAM, for Ø 3.8 mm, GH0.8 mm | C2242.3808 | S | |
| Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG® Titanium baseCAD/CAM, for Ø 3.8 mm, GH2.0 mm | C2242.3820 | ||
| Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG® Titanium baseCAD/CAM, for Ø 4.3 mm, GH0.8 mm | C2242.4308 | ||
| Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG® Titanium baseCAD/CAM, for Ø 4.3 mm, GH2.0 mm | C2242.4320 | ||
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG® Titanium baseCAD/CAM, for Ø 5.0 mm, GH0.8 mm | C2242.5008 | ||
| Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG® Titanium baseCAD/CAM, for Ø 5.0 mm, GH2.0 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, Ø4.5 mm, GH 0.8 mm | P2244.4408 | S | |
| iSy® Titanium base CAD/CAM, Ø4.5 mm, GH 2.0 mm | P2244.4420 | |||||
| iSy® Titanium base CAD/CAM, Ø5.2 mm, GH 0.8 mm | P2244.5008 | |||||
| iSy® Titanium base CAD/CAM, Ø5.2 mm, GH 2.0 mm | P2244.5020 | L |
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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.
§ 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.)