(120 days)
No
The summary describes a physical dental implant and associated surgical tools, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for surgical placement to support crowns, bridges, and overdentures in edentulous or partially edentulous patients, which serves to treat a medical condition (edentulism), thus making it a therapeutic device.
No
Explanation: The device is a dental implant designed for surgical placement to support crowns, bridges, and overdentures. Its purpose is to structurally support prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly details a physical implant made of titanium and associated surgical accessories made of stainless steel. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical placement in maxillary and/ or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed into bone. It discusses its shape, materials, and how it interacts with other components like abutments. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
In summary, the device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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 difters from the previously cleared 11 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 um 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 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 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 tit 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 triction 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 teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre 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 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 IT 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 drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests: A comparison was mode between the strength of the ITI Wide Diameter Implant and that of the 171 4.1 mm Solid Screw Implant (a predicate device), loaded at 4.5° 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.
key results: The study showed that failure loads of ITI Wide Diameter Implants when loaded at 45° or at 90° consistently exceed those of 171 4.1 mm Solid Screw Implants. These results demonstrate that the 111 5.6 mm diameter solid screw implant is substantially stronger in bending than the previously cleared 171 4.1 mm diameter solid screw implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 5, 5, 2, 8, and 1. The numbers are written in a cursive style, with some of the digits connected to each other. The overall appearance suggests that the sequence is part of a serial number or identification code.
ATTACHMENT 10 - 510(k) Summary
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
Name of the device 2.
ITI Wide Diameter Implant Trade Name: Endosseous dental implant and accessories Common Name: Endosseous dental implant Classification Name:
Logally marketed devices to which equivalence is claimed (predicate devices) 3.
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)
Description of the device 4.
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 difters from the previously cleared 11 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 um 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 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 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 tit 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 triction 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 teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre 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
1
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 IT 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 drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, 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.
| Feature | Subject Device
IM Wide Diameter Implant | Predicate Devices | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|
| | | II 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
10.0 | 8.0
10.0
12.0
14.0
16.0 | 6.0
8.0
10.0
12.0 | 7.0
8.5
10.0
13.0 | 8.0
10.0
13.0 |
| 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 |
Summary of technological characteristics ర్.
2
S Nonclinical tests
A comparison was mode between the strength of the ITI Wide Diameter Implant and that of the 171 4.1 mm Solid Screw Implant (a predicate device), loaded at 4.5° 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 171 4.1 mm Solid Screw Implants. These results demonstrate that the 111 5.6 mm diameter solid screw implant is substantially stronger in bending than the previously cleared 171 4.1 mm diameter solid screw implant.
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