(672 days)
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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1954758 510(k) SUMMARY
AUG 1 9 1997
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR § 807), and in particular § 807.92, the following summary of safety and effectiveness information is provided:
Submitted By
Swiss Dental Center 567 Marsh Street San Luis Obispo, California 93401 Telephone: (805) 541-1004 Telefacsimile: (805) 541-2523 Carol L. Phillips, D.D.S. Contact: Date Prepared: October 13, 1995
Device Name
| Trade or Proprietary Name: | Rootform Dental Implant System |
|---|---|
| Common or Usual Name: | Dental Implant |
| Classification Name: | Endosseous Implant (per 21 CFR § 872.3640) |
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Predicate Devices
| 510(k) | Sponsor | Device Name |
|---|---|---|
| K912262 | Imtec Corp. | Mini and UniversalImplants |
| K921966 | Steri-Oss | HA and TPS CoatedCylindrical Implants |
| K926101 | Phoenix Dental, Inc. | Opti-Max Dental Implant |
| K926102 |
Device Description
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
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Les Phillips Swiss Dental Center 567 Marsh Street San Luis Obispo, Californía 93401
AUG 1. 1997'
Re: K954758 Rootform Dental Implant System Trade Name: Requlatory Class: III Product Code: DZE Dated: June 6, 1997 Received: June 12, 1997
Dear Mr. Phillips
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Phillips
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Colaturo
Ulatowski hv A Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use
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."
Comparison to Predicate Devices
The technological characteristics of the current device closely parallel those of the predicate devices. For example, the current device and each of the predicate device implants as well as their associated prosthetic components are manufactured from the same material, titanium alloy (Ti6AL4V). The designs are also similar in that each implant is a two-stage, rootform, cylindrical, press-fit - type implant. As such they share many common features in addition to design principles including surgical implantation and loading procedures and restorative methods and techniques.
Summary of Nonclinical Tests
(( )
Not Applicable. The determination of substantial equivalence was not based on an assessment of performance data.
Summary of Clinical Tests
Not Applicable. The determination of substantial equivalence was not based on an assessment of performance data.
Conclusions of Nonclinical and Clinical Tests
Not Applicable
(Divizion Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.