(91 days)
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No
The description focuses on the mechanical design and materials of a dental abutment, with no mention of AI or ML capabilities.
No.
The device is an angled abutment used in dental implants for angulation correction and restoration, which is a structural component rather than a device intended to treat or cure a disease or condition for therapeutic purposes.
No
The device description indicates that the modified angled abutment is a component placed into a dental implant to provide support for prosthetic restorations. Its purpose is angulation correction for aesthetic results, not to diagnose a condition or disease.
No
The device description clearly states the device is a physical component made of titanium, a hardware material, and is provided in physical packaging.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 description clearly states that this device is a dental abutment, which is a component placed into a dental implant to support a prosthetic restoration (crown or bridge). It is a physical device used in the oral cavity, not for testing samples from the body.
- Intended Use: The intended use is for angulation correction in dental restorations for aesthetic results. This is a mechanical and structural function within the mouth, not a diagnostic test.
Therefore, this device falls under the category of a dental prosthetic component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.
Product codes
Not Found
Device Description
The ITI angled abutment is placed into the dental implant to provide support for the prosthetic restoration. The subject device of this 510(k) is a modification of the 171 Angled Abutment, previously cleared by FDA under K941393 for angulation correction in the saggital plane of the anterior maxilla. The intended use of the modified angled abutment is for angulation correction in all areas of the oral cavily.
The modified angled abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.
The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the 171 implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is also composed of Grade 4 titanium. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavily
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
K962647
oct. 7, 1996
ATTACHMENT 9 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) One Alewife Center, Cambridge, MA 02140-2317 Telephone Number: 617-868-3800 617-868-9111 Fax Number: Amy M. Gardner, Regulatory Attairs Manager Contact Person: Summary prepared: June 14, 1996
Name of the Device 2.
ITI Analed Abutment Trade Name: Abutment for endosseous dental implant Common Name: Accessory to a dental implant (21 CFR 872.3640) Classitication Name:
Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) 3.
- ITI Angled Abutment (K941393) 1.
-
- Branemark Angled Abutment (K905434)
-
- Calcitek Angled Abutment (K number unknown)
-
- 3i Angled Abutment (K number unknown)
4. Description of the Device
The ITI angled abutment is placed into the dental implant to provide support for the prosthetic restoration. The subject device of this 510(k) is a modification of the 171 Angled Abutment, previously cleared by FDA under K941393 for angulation correction in the saggital plane of the anterior maxilla. The intended use of the modified angled abutment is for angulation correction in all areas of the oral cavily.
The modified angled abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.
The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the 171 implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is also composed of Grade 4 titanium. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.
Accessories
A positioning aide is available to be inserted into the top of the abutment to assist the clinician in properly orienting the direction of angulation upon abutment insertion. The positioning aide is removed from the abulment after the basal screw has engaged the implant. The positioning aide is composed of anodized aluminum and is for single use only. A screwdriver is required to tighten the basal screw of the abutment into the implant through a lateral access hole in the coronal portion of the
1
abutment. The impression cylinder and transfer pin are composed of stainless steel. The impression cylinder is mounted into the occlusal threads on the coronal portion of the abutment when the impression is taken. The impression cylinder is then removed from the abutment and attached to the transter pin. The impression cylinder and transfer pin are reinserted into the impression material and the cast is poured, incorporating the transter pin and obtaining a precise replication of the abutment in the implant in the mouth. If the clinician decides to screw retain the prosthesis, as opposed to cementing, the occlusal screw is required to secure the final restoration to the abutment. The screw is composed of Grade 4 titanium. It occlusal space allows, the extension shell can be placed over the abutment to serve as an extended screw bed and screw channel for the occlusal screw.
5. Intended Use of the Device
The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.
| Subject Device | Predicate Devices | ||||
|---|---|---|---|---|---|
| ITI Modified | |||||
| Angled Abutment | Previously | ||||
| Cleared ITI | |||||
| Angled | |||||
| Abutment | Brånemark | ||||
| Angled | |||||
| Abutment | Calcitek Angled | ||||
| Abutment | 3i Angled | ||||
| Abutment | |||||
| Intended Use | |||||
| Provide support for | |||||
| dental prosthesis | Yes | Yes | Yes | Yes | Yes |
| For use with | |||||
| cemented | |||||
| restorations | Yes | Yes | Yes | Yes | Yes |
| For use with | |||||
| screw-retained | |||||
| restorations | Yes | Yes | No | No | No |
| Design | |||||
| Screwed into implant | |||||
| to be used as a base | |||||
| for dental prosthesis | Yes | Yes | Yes | Yes | Yes |
| Available degrees | |||||
| of angulation | 15 ° and 20° | 15 ° and 20° | 17° and 30° | 15° and 25° | 15°, 25°, |
| and 35° | |||||
| Composition | |||||
| Composed of | |||||
| Titanium | Yes | Yes | Yes | Yes | Yes |
| K Number | K905434 | unknown | unknown |