(330 days)
The ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants.
ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems:
Implants:
- Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm
- Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
- Zimmer Screw Vent: D3.5, D4.5, D5.7
- Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm)
- Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
- 31 Internal Connection: D3.4, D4.1, D5, D6
- Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5
Abutments:
- ASTRA TECH 20° and 45° UniAbutment
- ASTRA TECH UniAbutment EV: 3.6
- ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
- Nobel Biocare Multi -Unit Abutment RP: 4.0 mm
- Zimmer Tapered Abutment: 4.5mm
- Straumann RN(4.8mm), WN (6.5 mm)
- Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
- Straumann Bone Level Angled Abutment:4.0 mm
- 3I Low Profile Abutment
- Friadent XiVE MP D3.8. D4.5. D5.5
- Friadent XiVE TG D3.8, D4.5, D5.5
The ISUS Implant Suprastructures are metallic dental restorative devices which are intended for attachment by screw retention to dental implants to aid in the treatment of partially and totally edentulous patients for the purpose of restoring chewing function. The ISUS system consists of the Suprastructure devices themselves as well as retention screw accessories which facilitate their attachment to the dental implants.
The design of the ISUS Implant Suprastructures is derived from models of patient dentition which are produced by the dental professional using standard dental techniques. The dental models are converted to digital representations by DENTSPLY to facilitate DENTSPLY's Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) of the customized, patient-specific ISUS Implant Suprastructure.
The ISUS Implant Suprastructures consist of three (3) device types:
- Bars Intended to act as a supporting structure to facilitate attachment of removable dental prostheses.
- Bridges - Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
- Hybrids Intended as a metallic substructure to which finished dentures are bonded to form a fixed prosthesis.
The ISUS Implant Suprastructures are manufactured in versions composed of titanium and cobalt-chromium alloy and feature customized designs derived from individual patient dental impressions.
The provided 510(k) summary for the ISUS Implant Suprastructures indicates that no human clinical study was performed to support substantial equivalence. Therefore, the device does not have acceptance criteria or a study proving that it meets those criteria, as understood in terms of clinical performance metrics.
Instead, the submission relies on non-clinical performance data and comparison to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document, reflecting the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study with acceptance criteria was conducted, this table will reflect the non-clinical tests performed and their conformity to established standards or comparison to predicate devices.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical Integrity (Dynamic Fatigue) | Passed dynamic fatigue testing according to ISO 14801:2007, demonstrating a fatigue strength that supports substantial equivalence when compared to predicate devices and published in vitro bite/chewing forces. |
| Material Properties (Chemical Composition, Proof Strength, Elongation, Corrosion, Thermal Expansion, Metal-Ceramic Bond Strength) | Materials conform to the requirements specified in ISO 22674:2006 and ISO 9693:1999 for these characteristics. |
| Sterilization Parameters Validation | Recommended sterilization parameters were validated according to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices, but "representative worst-case test samples" were constructed for dynamic fatigue testing.
- Data Provenance: The tests are non-clinical, conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) because no clinical study was performed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable as no clinical ground truth was established for this submission. The "ground truth" for non-clinical tests is adherence to established international standards (ISO, ANSI/AAMI).
4. Adjudication Method for the Test Set
Not applicable as no clinical ground truth requiring adjudication was established.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. The submission explicitly states "No human clinical study was performed to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental suprastructure, not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Established International Standards: ISO 14801:2007 for dynamic fatigue, ISO 22674:2006 and ISO 9693:1999 for material properties, and ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010 for sterilization.
- Comparative Data: Comparison to results of equivalent testing on legally marketed predicate dental abutments and published in vitro data regarding maximum bite and chewing forces.
8. The Sample Size for the Training Set
Not applicable. No training set was used as this device is not an AI/ML algorithm or a device requiring a training phase based on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable as no training set was used.
§ 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.)