Search Results

The DAND Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

The DAND Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).

Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.

Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.

Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.

Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.

Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.

Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.

Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.

Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.

Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

Based on the provided FDA 510(k) clearance letter for the DAND Dental Implant System, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a set of performance tests and comparisons to the predicate, rather than a clinical trial or an AI-based study with ground truth establishment as would be seen for a diagnostic AI device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DAND Dental Implant System are implicitly defined by its substantial equivalence to the TOV Dental Implant System (K240837). The device must meet the performance and safety characteristics of the predicate. The "study" here is a series of non-clinical tests demonstrating that DAND devices perform comparably to the predicate and are safe for their intended use.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Performance Testing & Benchmarking)

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of implants tested for fatigue). It generally states that "Dynamic fatigue testing according to ISO 14801 was conducted," "Cytotoxicity testing according to ISO 10993 was done," etc. For general device clearances like this, the sample sizes would be determined by the relevant ISO/ASTM standards for each test (e.g., a specific number of samples for fatigue testing, specific biological samples for biocompatibility).
• Data Provenance: The tests are explicitly described as "non-clinical" and "in vitro" (e.g., fatigue testing, biocompatibility, sterilization validation, packaging). There is no mention of human clinical data or geographical origin of such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• None applicable for this type of device and submission. This medical device is a Class II dental implant, cleared via 510(k) demonstrating substantial equivalence to an existing device. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM) for materials, design, biocompatibility, and mechanical performance, and by direct comparison to the predicate device’s characteristics. This is not an AI/diagnostic device where expert radiologists would establish ground truth for image interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. As this is not an AI/diagnostic study involving human readers or subjective interpretations, there is no expert adjudication process described. Test results are quantitative measurements against established standards.

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:

• Not applicable. This submission is for a physical medical device (dental implant system), not an AI software or a diagnostic imaging device. Therefore, no MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI algorithm. The performance evaluation is for the physical implant system's mechanical, material, and biological properties.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on engineering and performance standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility) and direct comparison to the established characteristics of the legally marketed predicate device. The device demonstrates equivalence in its physical and mechanical properties, as well as its intended use. There is no biological or clinical "ground truth" established from patient outcomes or pathology reports in this 510(k) summary.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As there is no training set for an AI model, this question is not relevant.

Ask a specific question about this device