(107 days)
No
The summary describes a dental prosthetic system involving CAD/CAM technology for milling, but there is no mention of AI or ML being used in the design or manufacturing process.
No
This device is a dental abutment solution used to support cement-retained restorations, specifically for restoring function and aesthetics in the oral cavity. It is not designed to treat or cure a disease or medical condition.
No
The device is an IPS e.max CAD Abutment Solutions used for single cement-retained restorations in support of dental implants, which is a prosthetic component, not a diagnostic tool.
No
The device description explicitly states the system comprises three parts: IPS e.max CAD mesostructure, Ti base, and CAD/CAM software. The mesostructure and Ti base are physical components, making it a hardware and software system, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the mouth for supporting dental restorations on implants. This is an in-vivo application, not an in-vitro diagnostic test performed on samples outside the body.
- Device Description: The description details a physical component (lithium disilicate blocks and titanium bases) used to create dental abutments and crowns. This is a prosthetic device, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health condition.
The device is a dental prosthetic system used for restoring function and esthetics in patients with missing teeth.
N/A
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 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.
Product codes
NHA
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.
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
Trained professional
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
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.
Key Metrics
Not Found
Predicate Device(s)
Sirona Dental CAD/CAM System (K111421), IPS e.max CAD (K051705), IPS e.max Press Abutment Solutions (K120053 and K124008)
Reference Device(s)
Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088), Biomet 3i Certain (K014235), K062129, K060958, Biomet 3i Osseotite (K980549)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
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
1
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 |
| 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 |
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).
2
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 Andre 2013.10.30
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 2