INTERPORE THREADED IMPLANT

K960371 · Interpore Intl. · DZE · Mar 8, 1996 · Dental

Device Facts

Record IDK960371
Device NameINTERPORE THREADED IMPLANT
ApplicantInterpore Intl.
Product CodeDZE · Dental
Decision DateMar 8, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

Commercially pure titanium endosseous threaded implant; features external hex configuration for anti-rotation in single-tooth applications; apical flutes facilitate self-tapping installation. Used by dental surgeons for oral reconstruction; two-phase procedure: Phase I involves surgical placement in mandible/maxilla, followed by 3-4 month osteointegration period; Phase II involves abutment attachment and prosthetic restoration. Device provides mechanical interface for fixed/removable prosthodontic appliances; benefits patient through restoration of dental function and aesthetics.

Clinical Evidence

Bench testing only. Static mechanical testing performed on the INTERPORE Threaded Implant compared to existing mechanical data for the Branemark 3.75 mm Threaded Implant; results indicated the subject device was significantly stronger.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F-67) and Ti-6AL-4V ELI alloy (ASTM F-136). Components: Implant cylinder, hex cover screw, healing abutments, impression copings, implant analogs, gold/plastic prosthetic components, paralleling pins, thread taps, and 17-4PH stainless steel (ASTM A-564) spade drills. Design: Endosseous threaded implant with external hex and apical cutting flutes. Sterilization: Not specified.

Indications for Use

Indicated for oral reconstruction in totally edentulous mandible/maxilla, large edentulous spans, bilateral/unilateral free-ends, and single tooth edentulous spaces. Contraindications: uncontrolled parafunctional habits, significant vascular impairment, metabolic bone disease, clotting disorders, current drug/radiation/steroid/anticoagulant therapy, uncontrolled diabetes, insufficient ridge dimensions, or active intraoral infection.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} K960371 INTERPORE International 510(k) Premarket Notification INTERPORE Self-Tapping Threaded Implant Page 18 Exhibit 3 510(k) SUMMARY {1} INTERPORE International 510(k) Premarket Notification INTERPORE Self-Tapping Threaded Implant Page 19 # 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} INTERPORE International 510(k) Premarket Notification INTERPORE Self-Tapping Threaded Implant 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 treatment 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} INTERPORE International 510(k) Premarket Notification INTERPORE Self-Tapping Threaded Implant Page 21 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. | {4} INTERPORE International 510(k) Premarket Notification INTERPORE Self-Tapping Threaded Implant Page 22 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.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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