(42 days)
Not Found
Not Found
No
The description focuses solely on the mechanical design and materials of a dental implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant used for oral reconstruction to replace missing teeth, which addresses a health condition.
No
The device is an implant for oral reconstruction, designed to become an osteointegrated prosthesis. It is not used to diagnose a medical condition.
No
The device description clearly details a physical, commercially pure titanium implant with specific mechanical features and intended for surgical implantation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The INTERPORE Self-Tapping Threaded Implant is a physical implant designed to be surgically placed into the jawbone (mandible or maxilla) for oral reconstruction.
- Intended Use: Its intended use is to serve as a base for attaching prosthetic appliances (like crowns or dentures) directly within the patient's body.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples outside of the body.
N/A
Intended Use / Indications for Use
The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.
Product codes
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Device Description
The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant.
The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate. It also provides a wide variety of options with regard to the types of abutments that can be used for attachment of prostheses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static testing was performed on the INTERPORE Threaded Implant and compared with existing mechanical test data for the Branemark 3.75 mm Threaded Implant. Results showed that the INTERPORE Threaded Implant was significantly stronger than the Branemark implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nobelpharma Threaded Implants, Implant Innovations, Inc. (3i) Threaded Implants, Lifecore Threaded Implants
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Exhibit 3
,
510(k) SUMMAR Y
1
510(k) SUMMARY
SUBMITTED BY
David P. Balding Director, Regulatory Affairs and Quality Assurance INTERPORE International 181 Technology Drive Irvine, California 92718 (714) 453-3200
Date Submitted: January 25, 1996
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Endosseous Implant |
|---|---|
| Common/Usual Name: | Dental Implant |
| Proprietary Names: | INTERPORE Threaded Implant (Wide Diameter) |
PREDICATE DEVICES
Nobelpharma Threaded Implants Implant Innovations, Inc. (3i) Threaded Implants Lifecore Threaded Implants
DEVICE DESCRIPTION
The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant.
The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate.
2
It also provides a wide variety of options with regard to the types of abutments that can be used for attachment of prostheses.
INDICATIONS FOR USE
The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.
PRINCIPLES OF OPERATION
Oral reconstruction using the INTERPORE Self-Tapping Threaded Implant is a two phase procedure. In Phase I, the implant cylinder is surgically implanted in the residual ridge of the mandible or maxilla. Internally irrigated, precision drills are used to prepare the implant site. The INTERPORE Self-Tapping Threaded Implant is designed to be either self-tapped into place or the implant site may be pre-tapped using the Hand Bone Tap and Mount Driver or Ratchet Wrench. The implant is then properly seated, and the titanium Hex Cover Screw is affixed to seal the implant. Soft tissue is sutured into place to cover the implant and the implant is allowed to heal (osteointegrate) for approximately three to four months. During the healing period, the implant is not loaded, thus allowing the implant to heal in a stress-free environment.
After healing, Phase II procedures are initiated. The soft tissue over the implant is reopened, and the titanium Hex Cover Screw is removed. It is replaced with the Hex Healing Abutment, an abutment of appropriate height and diameter, which allows the gingiva to heal to the desired contour. Approximately two weeks later, the Hex Healing Abutment is removed and an impression of the top of the implant is made using an appropriate Hex Impression Coping which is mounted on the implant. Once the impression is made, the impression coping is removed and the Hex Healing Abutment is replaced onto the implant until the construction of the prosthodontic appliance has been completed by the dental laboratory. Final attachment of the prosthesis involves removing the Hex Healing Abutment, seating the prosthesis and tightening the titanium retaining screw.
CONTRAINDICATIONS
Contraindications customary to oral surgery should be observed. These include, but are not limited to, uncontrolled parafunctional habits, significant vascular impairment to the implant site, metabolic bone disease, clotting disorders, current with therapeutic agents which may have an effect on the surgical site, the surrounding tissue or normal biological healing responses (i.e., drug therapy, radiation therapy, chronic steroid treatment,
3
anticoagulant therapy) and uncontrolled diabetes or other metabolic or systemic disorders which affect bone or wound healing.
The implant must not be used in patients where ridge dimensions are insufficient to accommodate proper implant placement.
Implants should not be used in patients who present with an active intraoral infection at the time of placement.
COMPLICATIONS
The following complications have been reported in association with surgical procedures employing endosteal implants: failure to osteointegrate, loosening and loss of implant, soft tissue irritation due to insufficient width of attached gingiva, infection, early loss of implant due to inability to remove healing screw at reopening, implant loosening and fracture associated with coronal bone loss with apical retention.
MATERIALS OF CONSTRUCTION
| Implant Cylinder | Commercially pure titanium conforming to ASTM F-67,
Unalloyed Titanium for Surgical Implant Applications. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Hex Cover Screw | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Healing Abutments | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Impression Copings | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Implant Analogs | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
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| Titanium Prosthetic
Components | Commercially pure titanium conforming to ASTM F-67,
Unalloyed Titanium for Surgical Implant Applications. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Gold Prosthetic
Components | Ceramicor, Everlast, or equivalent gold alloy with the following
composition: 60% Gold, 20% Platinum, 20% Palladium |
| Castable Plastic
Components | Delrin Resin #500, Manufactured by DuPont. |
| Paralleling Pin | Commercially pure titanium conforming to ASTM F-67,
Unalloyed Titanium for Surgical Implant Applications. |
| | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Thread Taps | Commercially pure titanium conforming to ASTM F-67,
Unalloyed Titanium for Surgical Implant Applications. |
| | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136,
Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant
Applications. |
| Spade Drills | 17-4PH Stainless Steel (UNS-S17400) conforming to ASTM
A-564, Hot-Rolled and Cold-Finished Age-Hardening Stainless
and Heat-Resisting Steel Bars and Shapes. |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The design, material, configurations, method of sterilization and other technological characteristics are similar to currently marketed predicate devices.
NONCLINICAL TEST CONCLUSIONS
Static testing was performed on the INTERPORE Threaded Implant and compared with existing mechanical test data for the Branemark 3.75 mm Threaded Implant. Results showed that the INTERPORE Threaded Implant was significantly stronger than the Branemark implant.