(107 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 mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure 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, Ti bases and CAD/CAM systems are shown below: Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549) CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above. For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.
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. Titanium bases are a premanufactured prosthetic component directly connected to dedicated endosseous dental implants. The Titanium base is used for adhesion to mesostructures to restore function and esthetics in the oral cavity. 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 include in the shipped block. Connection geometries fit select Titanium Bases marketed by Straumann, Nobel Biocare and Biomet 31 as identified in the Intended Use section. The mesostructure is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown as designed by the trained professional using the Sirona inLab and Cerec SW 4.2 (or higher) software.. The device serves as the esthetic mesostructure which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.
This document describes the IPS e.max® CAD Abutment Solutions, a dental device consisting of a lithium disilicate ceramic mesostructure cemented to a titanium base, designed for single cement-retained restorations in conjunction with endosseous dental implants.
1. Acceptance Criteria and Reported Device Performance:
The device's performance is assessed against physical properties outlined in ISO 6872:2008 for Dental Ceramics. The acceptance criteria and reported values are provided in the table below:
| Acceptance Criteria (Test Method: ISO 6872) | Reported Device Performance (IPS e.max CAD) |
|---|---|
| CTE (100°C - 500°C) | 10.5 ± 0.5 10⁻⁶ K |
| Flexural strength (Biaxial) | > 360 MPa |
| Fracture toughness | ≥ 2.0 MPa √m |
| Chemical solubility | < 50 µg/cm² |
| Crystallization temperature | 840 - 850°C |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each physical property test. It refers to general "fatigue testing" performed for angled abutments according to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments" (May 12, 2004). The data provenance is not specified beyond being generated as part of a 510(k) submission to the FDA. The tests would likely be prospective studies conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The "ground truth" for this device is not established by expert consensus on clinical images or diagnoses. Instead, "ground truth" refers to the established physical properties specified by international standards (ISO 6872:2008) for dental ceramics. The qualification of individuals conducting these standardized laboratory tests would typically be in materials science, engineering, or a related field, but specific expert qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., medical imaging reviews), not for physical property testing of materials against specified standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or conducted. This type of study is not relevant for evaluating the physical properties of a dental materials device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable. The device is a material and design system for dental restorations; it is not an algorithm or AI system. Its performance relates to its physical and mechanical properties, not an algorithmic output.
7. Type of Ground Truth Used:
The ground truth used for evaluating this device's performance is based on established international standards for physical properties of dental ceramics (ISO 6872:2008). This is a form of objective, quantitative measurement against pre-defined benchmarks, rather than subjective expert consensus, pathology, or outcomes data in a clinical setting for this specific aspect of the submission.
8. Sample Size for the Training Set:
This information is not applicable. The IPS e.max® CAD Abutment Solutions is a physical dental device/material, not an AI or machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for this device.
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510(K) SUMMARY (revised)
IPS e.max® CAD Abutment Solutions
| Contact: | Donna Marie Hartnett, Director QA/Regulatory Affairs |
|---|---|
| Company: | Ivoclar Vivadent. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010 |
| Date Prepared: | October 18, 2013 |
| Proprietary Name: | IPS e.max® CAD Abutment Solutions |
| Classification Name: | Abutment, Implant, Dental Endosseous (872.3630) |
| Predicate Devices: | Sirona Dental CAD/CAM System (K111421)IPS e.max CAD (K051705)IPS e.max Press Abutment Solutions (K120053 and K124008) |
Device Description: 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. Titanium bases are a premanufactured prosthetic component directly connected to dedicated endosseous dental implants. The Titanium base is used for adhesion to mesostructures to restore function and esthetics in the oral cavity. 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 include in the shipped block. Connection geometries fit select Titanium Bases marketed by Straumann, Nobel Biocare and Biomet 31 as identified in the Intended Use section. The mesostructure is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown as designed by the trained professional using the Sirona inLab and Cerec SW 4.2 (or higher) software.. The device serves as the esthetic mesostructure which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.
Predicate Device: The predicate device to which IPS e.max® CAD Abutment Solutions has been compared is Sirona Dental CAD/CAM System(K111421). For this application, IPS e.max® CAD Abutment Solutions has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that IPS e.max® CAD Abutment Solutions is substantially equivalent to the predicate device.
510K Summary 5-1
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510(K) SUMMARY (revised)
IPS e.max® CAD Abutment Solutions
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 and
CAD/CAM software
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, Ti bases and CAD/CAM systems are shown below:
Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088,), Biomet 3i Certain (K014235)
| Titanium bases: | ||
|---|---|---|
| and the contract and the contract and the comments of the property of the province of the supportunity | Company of the country of the county of the county of |
| Implantmanufacturer | Implant System | ImplantDiameter(mm) | TiBase | Sirona Ref. | Interfacesize |
|---|---|---|---|---|---|
| Nobel Biocare | Replace NP | 3.5 | NBRS 3.5 | 6282474 | L |
| Nobel Biocare | Replace RP | 4.3 | NBRS 4.3 | 6282482 | L |
| Nobel Biocare | Replace WP | 5.0 | NBRS 5.0 | 6282490 | L |
| Nobel Biocare | Replace 6.0 | 6.0 | NBRS 6.0 | 6282508 | L |
| Nobel Biocare | Nobel Active NP | 3.5 | NB A 4.5 | 6208188 | L |
| Nobel Biocare | Nobel Active RP | 4.3 / 5.0 | NB A 5.0 | 6208253 | L |
| Straumann | Bone Level NC | 3.3 | S BL 3.3 | 6308154 | L |
| Straumann | Bone Level RC | 4.1 / 4.8 | S BL 4.1 | 6308337 | L |
| Biomet 3i | Certain | 3.4 | B C 3.4 | 6308048 | S |
| Biomet 3i | Certain | 4.1 | B C 4.1 | 6308097 | L |
| Biomet 3i | Certain | 5.0 | B C 5.0 | 6308121 | L |
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.
Material Composition: The device is composed or proprietary lithium disilicate (Li Si 2) dental ceramic and is identical in composition to IPS e/max CAD (K051705).
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510(K) SUMMARY (revised)
IPS e.max® CAD Abutment Solutions
Technological Characteristics: The device design, i.e. delivery form, and intended use of IPS e.max CAD Abutment Solutions and the predicate device are the same. The materials comply with ISO 6872:2008 for Dental Ceramics. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.
Scientific Concept: The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics made from lithium disilicate, a material proven to be suitable for safe and effective dental restoratives.
Testing Summary: According to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments" may 12, 2004, fatigue testing has been performed for angled abutments.
Physical properties of IPS e.max CAD:
- CTE (100°C 500°C) 10.5 ± 0.5 10 %K ー > 360 MPa (Test Method ISO 6872) -Flexural strength (Biaxial) ≥ 2.0 MPa moss (Test Method ISO 6872) Fracture toughness -Chemical solubility < 50 []g/cm2 (Test Method ISO 6872) --Crystallization temperature 840 - 850°C
Conclusion: IPS e.max CAD Abutment Solutions is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with outstretched wings, with three wavy lines extending from the eagle's body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 31, 2013
Ivoclar Vivadent AG C/O Donna Hartnett Director of Quality Affairs/Regulatory Affairs Ivoclar Vivadent, Incorporation 175 Pineview Dr. AMHERST NY. 14228
Re: K132209
Trade/Device Name: IPS e.max® CAD Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: August 6, 2013 Received: August 7, 2013
Dear Ms. Hartnett:
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. 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.
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
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Page 2 - Ms. Hartnett
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MarylSBuner-S
Kwame Ulmer, MS Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132209
Device Name: IPS e.max® CAD Abutment Solutions
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 mesostructure, Ti base and CAD/CAM software.
The IPS e.max CAD mesostructure 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, Ti bases and CAD/CAM systems are shown below:
Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549)
CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above
| Implant manufacturer | Implant System | Implant Diameter (mm) | TiBase | Sirona Ref. | Interface size |
|---|---|---|---|---|---|
| Nobel Biocare | Replace NP | 3.5 | NBRS 3.5 | 6282474 | L |
| Nobel Biocare | Replace RP | 4.3 | NBRS 4.3 | 6282482 | L |
| Nobel Biocare | Replace WP | 5.0 | NBRS 5.0 | 6282490 | L |
| Nobel Biocare | Replace 6.0 | 6.0 | NBRS 6.0 | 6282508 | L |
| Nobel Biocare | Nobel Active NP | 3.5 | NB A 4.5 | 6208188 | L |
| Nobel Biocare | Nobel Active RP | 4.3 / 5.0 | NB A 5.0 | 6208253 | L |
| Straumann | Bone Level NC | 3.3 | S BL 3.3 | 6308154 | L |
| Straumann | Bone Level RC | 4.1 / 4.8 | S BL 4.1 | 6308337 | L |
| Biomet 3i | Certain | 3.4 | B C 3.4 | 6308048 | S |
| Biomet 3i | Certain | 4.1 | B C 4.1 | 6308097 | L |
| Biomet 3i | Certain | 5.0 | B C 5.0 | 6308121 | L |
Titanium bases:
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 2
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For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.
Prescription Use __ _ _ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Andre 2013.10.30
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 2
§ 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.)