ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES

K955281 · The Straumann Co. · DZE · Mar 15, 1996 · Dental

Device Facts

• Record ID: K955281
• Device Name: ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES
• Applicant: The Straumann Co.
• Product Code: DZE · Dental
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

Device Story

ITI Wide Diameter Implant is a one-stage root-form endosseous dental implant; fabricated from commercially pure titanium Grade 4 (ASTM F67); features titanium plasma-sprayed (TPS) coating on anchorage surface; smooth machined neck for epithelial attachment. Implant utilizes cone-screw construction for abutment connection; provides mechanically locking friction fit. External design includes spiral screw threads with 75-degree compressive flank angle to direct forces into bone. Device is surgically placed by dentists in clinical settings; requires specific pilot drills, twist drills, and thread taps for site preparation. Output is a stable base for prosthetic restorations (crowns, bridges, overdentures). Increased diameter compared to standard implants provides enhanced bending strength, benefiting patients with limited vertical bone height by offering greater structural support.

Clinical Evidence

Bench testing only. Mechanical strength testing compared ITI Wide Diameter Implant to ITI 4.1 mm Solid Screw Implant. Implants embedded in PMMA and loaded at 45° and 90° to the implant axis. Results showed failure loads for the Wide Diameter Implant consistently exceeded those of the 4.1 mm predicate, demonstrating superior bending strength.

Technological Characteristics

Material: Commercially pure titanium Grade 4 (ASTM F67). Accessories: Martensitic stainless steel (DIN 1.4112/AISI 440B) and austenitic stainless steel (DIN 1.4305/AISI 303). Surface: Titanium plasma-sprayed (TPS) coating (20-30 µm). Design: One-stage root-form, 5.6 mm major diameter, 8-10 mm length. Connection: Tapered internal cone with screw thread. Energy: None (mechanical). Connectivity: None.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental implants to support crowns, bridges, or overdentures in the maxillary or mandibular arch, specifically in areas with sufficient transverse bone and limited vertical bone height.

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

• ITI 4.1 mm Solid Screw Implant (K894595, K920768)
• Nobelpharma Brånemark System - 5.5 mm Fixture (K926501)
• Implant Innovations, Inc. wide diameter implants
• Lifecore Biomedical Wide Diameter Implant (K944068)

Submission Summary (Full Text)

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K955281

# ATTACHMENT 10 - 510(k) Summary

## 1. Applicant's name and address

Straumann USA (on behalf of Institut Straumann AG)
One Alewife Center, Cambridge, MA 02140-2317
617-868-3800
Carolyn M. Bitetti, Director, Regulatory Affairs
Summary prepared November 14, 1995

## 2. Name of the device

Trade Name: ITI Wide Diameter Implant
Common Name: Endosseous dental implant and accessories
Classification Name: Endosseous dental implant

## 3. Legally marketed devices to which equivalence is claimed (predicate devices)

ITI 4.1 mm Solid Screw Implant (K894595, K920768)
Nobelpharma Brånemark System - 5.5 mm Fixture (K926501)
Implant Innovations, Inc. wide diameter implants (K number unknown)
Lifecore Biomedical Wide Diameter Implant (K944068)

## 4. Description of the device

### Implants

The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared ITI 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 µm thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard ITI abutments to be used. The abutment mates with a tapered internal cone of the implant; at its apex is a threaded region into which the matching thread of the abutment is screwed. The implant shoulder, which forms a mating surface for prosthetic components, is machined with a 45° chamfer to maximize prosthesis stability. The diameter at the coronal end, the internal taper, and thread for attachment of the abutment and the 45° chamfer are identical to those of the ITI 4.1 mm Solid Screw Implant.

For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal fit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking friction fit (similar to Morse taper, a principle that has been used in machine shops for many years).

The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal feature of the thread form is the fact that the compressive (flank) surface of the thread is oriented at 75° to the implant axis, directing compressive forces into the bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the

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implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm.

## Accessories

The surgical technique intended for the implant includes initial use of the same ITI 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by the use of the standard ITI 3.5 mm twist drill. Twist drills of 4.2 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All ITI twist drills and thread taps are made from martensitic stainless steel (DIN 1.4112, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).

## 5. Intended use of the device

The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

## 6. Summary of technological characteristics

| Feature | Subject Device | Predicate Devices | | | |
| --- | --- | --- | --- | --- | --- |
| | ITI Wide Diameter Implant | ITI 4.1 mm Solid Screw Implant (K894595, K920768) | Nobelpharma Brånemark System 5.5 mm Fixture (K926501) | Implant Innovations Wide Diameter Implant (K# unknown) | Lifecore Biomedical Wide Diameter Implant (K944068) |
| Intended Use | | | | | |
| Surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients | YES | YES | YES | YES | YES |
| Material | | | | | |
| CP Ti | YES | YES | YES | YES | YES |
| Design | | | | | |
| External screw threads | YES | YES | YES | YES | YES |
| Diameter (mm) | 5.6 | 4.1 | 5.5 | 5.0, 6.0 | 5.0, 5.5, 6.0 |
| Lengths implanted (mm) | 8.0 | 8.0 | 6.0 | 7.0 | 8.0 |
| | 10.0 | 10.0 | 8.0 | 8.5 | 10.0 |
| | | 12.0 | 10.0 | 10.0 | 13.0 |
| | | 14.0 | 12.0 | 13.0 | |
| | | 16.0 | | | |
| One stage | YES | YES | NO | NO | NO |
| Implant/abutment taper | YES | YES | NO | NO | NO |
| External hex | NO | NO | YES | YES | YES |
| TPS Coating | YES | YES | NO | NO | NO |

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# 7. Nonclinical tests

A comparison was made between the strength of the ITI Wide Diameter Implant and that of the ITI 4.1 mm Solid Screw Implant (a predicate device), loaded at 45° to the implant axis and at 90° to the implant axis. Implants were imbedded in (polymethylmethacrylate) PMMA, ITI solid abutments were inserted in the implants and stainless steel test couplings (simulating prosthetic restorations) were mounted on the abutments. Tests were conducted by applying monotonic increasing loads to the test couplings until loads decreased or failure occurred. Force vs. deflection curves were recorded for each test and the mode of failure was noted.

The study showed that failure loads of ITI Wide Diameter Implants when loaded at 45° or at 90° consistently exceed those of ITI 4.1 mm Solid Screw Implants. These results demonstrate that the ITI 5.6 mm diameter solid screw implant is substantially stronger in bending than the previously cleared ITI 4.1 mm diameter solid screw implant.

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