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510(k) Data Aggregation
(176 days)
QUAD Dental Implants and Prostheses
DenTack QUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw
The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
Here's an analysis of the acceptance criteria and supporting studies for the DenTack QUAD Dental Implants and Prostheses based on the provided document:
Acceptance Criteria and Device Performance for DenTack QUAD Dental Implants and Prostheses
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Fatigue Test (ISO 14801:2007) | Device performs at least as good as or better than the predicate device. | "The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." Tested on worst-case configuration (25° abutment with narrowest implant OD). |
| Evaluation of Minimal Rotation Torque after Placement and Expansion | Test results to be similar to and thus equivalent to the predicate device. | "The tests results found to be very similar and thus equivalent. The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." |
| Partially expanded QUAD Implant Reciprocating Effect Test | No additional damage to surrounding bone or implant from counterclockwise/clockwise rotation; performs similarly to reference device. | "The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device." |
| Material & Surface Characteristics | ||
| Surface Analysis (SEM) | - | Implant surface tested using SEM. (No specific acceptance criteria or performance metric beyond "tested" is stated). |
| Biocompatibility (ISO 10993-1, -5, -12) | No incompatibility potential or adverse biological effect. | "The chemical and biological tests have not revealed any incompatibility potential or any adverse effect." |
| Sterilization & Packaging | ||
| Gamma Sterilization Validation (ISO 11137-2, AAMI TIR 33 / ISO TS 13004) | Successful sterilization according to standards. | "Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method..." |
| Steam Sterilization Validation (ISO 17665-1:2006, ANSI AAMI ST79:2010, ANSI AAMI ST77:2013) | Validation results support SAL 10⁻⁶; IFU in-line with validation. | "The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results." |
| Shelf Life Validation (ISO 11607-1) | Sterility maintained for the device shelf life. | "This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life." |
| Functional/Clinical Equivalence | ||
| QUAD Removal after Expansion | The expandable design does not cause additional damage to the surrounding tissue. | "The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for most of the individual tests. It generally refers to testing being conducted "for Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and "in comparison to predicate device" or "legally marketed device."
- Fatigue Test (ISO 14801:2007): "Worst case configuration was selected." (Implies a specific combination of implant and abutment was tested, but no number of samples is given).
- QUAD Removal after Expansion: "artificial bone was used and a reference legally marketed device for comparison." (No number of samples or explicit provenance beyond "artificial bone").
- Evaluation of Minimal Rotation Torque: "artificial bone." (No number of samples).
- Partially expanded QUAD Implant Reciprocating Effect Test: "a legally marketed device with similar instructions for use." (No number of samples).
- Biocompatibility (ISO 10993-1, -5, -12): "final and sterilized products." (No number of samples).
- Sterilization and Shelf Life Validations: Not specified, but generally follow specific standards.
The data provenance is largely implied to be laboratory-based testing using in vitro models (e.g., artificial bone) and comparisons to existing devices, rather than in vivo or human data. There is no information regarding country of origin for the data other than the company being based in Israel. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
No direct mention of experts or their qualifications establishing "ground truth" for the test set is provided. The studies described are primarily engineering and laboratory performance tests against industry standards (e.g., ISO, AAMI) or in comparison to predicate devices, rather than clinical studies requiring expert consensus on outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests are primarily physical, chemical, and mechanical evaluations against defined standards and comparative performance with predicate devices, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document describes laboratory and engineering tests, not clinical studies involving human readers or cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical medical device (dental implants and prostheses), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the various studies is typically defined by:
- Industry Standards: Compliance with international standards (e.g., ISO 14801, ISO 10993 series, ISO 11137-2, ISO 17665-1, ISO 11607-1).
- Comparative Performance: The performance of legally marketed predicate devices or reference devices, establishing a benchmark for substantial equivalence.
- Defined Benchmarks/Thresholds: For tests like sterilization success (SAL 10⁻⁶) or fatigue limits implied by ISO standards.
- Qualitative Assessment: Such as "no additional damage" or "no incompatibility potential" demonstrated in material science or biological tests.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is for a physical medical device clearance, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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