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The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abetment and prosthetic devices including artificial teeth, bridges, and dentures.

The Rootform Dental Implant System has two "families" -- one without a hex top with 3.3 mm and 3.8 mm diameter cylinders and a second with a hex lock top with 3.3 mm and 4.0 mm diameters.

The components of each system are as follows:

Rootform 3.3 mm and 3.8 mm Non-Hex Top Implant System

• Implants with internal thread
• Cover screws
• Healing abutments
• Prepable abutments
• Bar or tissue abutments
• Abutment screws
• Tissue abutment with cap
• Prosthetic attachment screws

Rootform 3.3 mm and 4.0 mm Universal Hex Top Implant System

• Implants with internal thread
• Cover screws
• Fixation screws
• Healing abutments
• Straight abutments
• Angled abutments

This 510(k) summary describes a dental implant system. The provided document explicitly states that the determination of substantial equivalence was NOT based on an assessment of performance data (nonclinical or clinical). Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance
• Sample sizes, data provenance, and ground truth information for test sets
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance
• Sample size and ground truth establishment for training sets

The device's substantial equivalence was determined by comparing its technological characteristics to predicate devices.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Not applicable. The determination of substantial equivalence was not based on an assessment of performance data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance data (nonclinical or clinical) were assessed for the determination of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No performance data (nonclinical or clinical) were assessed for the determination of substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance data (nonclinical or clinical) were assessed for the determination of substantial equivalence.

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. No performance data (nonclinical or clinical) were assessed for the determination of substantial equivalence.

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

Not applicable. This device is a dental implant system, not an AI algorithm. No standalone performance evaluation was performed for the determination of substantial equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance data (nonclinical or clinical) were assessed for the determination of substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a dental implant system, not an AI algorithm. No training set was used for the determination of substantial equivalence.

9. How the ground truth for the training set was established

Not applicable. This device is a dental implant system, not an AI algorithm. No training set was used for the determination of substantial equivalence.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The Rootform Dental Implant System's acceptance for market clearance was based on demonstrating substantial equivalence to legally marketed predicate devices, not on explicit performance criteria from clinical or nonclinical studies.

The study involved a comparison of technological characteristics between the Rootform Dental Implant System and the following predicate devices:

• Imtec Corp. Mini and Universal Implants (K912262)
• Steri-Oss HA and TPS Coated Cylindrical Implants (K921966)
• Phoenix Dental, Inc. Opti-Max Dental Implant (K926101 and K926102)

The key characteristics evaluated for comparability were:

• Material: All implants and associated prosthetic components are manufactured from the same material: titanium alloy (Ti6AL4V).
• Design: All implants are described as two-stage, rootform, cylindrical, press-fit type implants.
• Common Features: They share similar design principles, surgical implantation and loading procedures, and restorative methods and techniques.

Conclusion: The FDA determined that the device is substantially equivalent to the predicate devices based on this comparison of technological characteristics. No performance data from nonclinical or clinical tests were used or required for this determination.

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