(84 days)
The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the orgal cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.
The ITI Protection Healing Cap is a device which is mounted onto an 171 implant after the abutment has been placed into the implant and serves to protect the outer configuration of the abutment and which the clinician can modify to maintain and condition the precise contours of the soft tissue during the prosthetic phase. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The protection healing caps remain in place for approximately 2 weeks while the tinal restoration is being constructed.
The ITI Protection Healing Cap is available in two sizes. The small cap has a diameter of 5.8 mm and a height of 4.0 mm. The large cap has a diameter of 6.2 mm and a height of 5.0 mm. The Profection Healing Caps are designed with a 65° bevel which extends 0.5 mm (small) to 0.7 mm (large) beyond the outer edge of the implant making it possible to modify the dimension of the caps.
The ITI Protection Healing Caps are composed of Polyetheretherketone (PEEK) which is extruded from its granulated form and lathed to form the caps.
The provided text describes a medical device, the ITI Protection Healing Cap, and compares it to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any details related to AI, algorithms, or human reader performance.
Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, AI/algorithm performance) is not present in the provided text.
Specifically, the document is a 510(k) summary for a physical medical device (a dental healing cap), not an AI/software device. The sections you requested (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically relevant for studies evaluating the performance of diagnostic or prognostic algorithms, especially in imaging or data analysis.
The document focuses on:
- Device Description: What the device is made of and how it works.
- Intended Use: What the device is for.
- Comparison to Predicate Devices: Showing that the new device is substantially equivalent to existing, legally marketed devices based on features like material, design (dimensions), and intended use.
There is no mention of any study to prove specific performance metrics or acceptance criteria beyond the general concept of substantial equivalence to predicate devices for regulatory clearance.
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K9620JB
ATTACHMENT 7 - 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 Fax Number: 617-868-9111 Contact Person: Ms. Amy M. Gardner, Regulatory Affairs Manager Summary Prepared March 15, 1996
Name of the Device 2.
ITI Protection Healing Cap Trade Name: Common Name: Healing Cap Accessory to a dental implant (21 CFR 872.3640) Classification Name:
Legally Marketed Devices to which Equivalence is Claimed 3. (Predicate Devices)
Nobelpharma's Brånemark System Healing Caps (K Number 925780) Calcitek's Abutment Comfort Caps (K Number unknown) Interpore International's Abutment Complete Sealing Caps (K Number 912734) Steri-Oss' Healing Cap (K Number unknown)
Description of the Device 4.
The ITI Protection Healing Cap is a device which is mounted onto an 171 implant after the abutment has been placed into the implant and serves to protect the outer configuration of the abutment and which the clinician can modify to maintain and condition the precise contours of the soft tissue during the prosthetic phase. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The protection healing caps remain in place for approximately 2 weeks while the tinal restoration is being constructed.
The ITI Protection Healing Cap is available in two sizes. The small cap has a diameter of 5.8 mm and a height of 4.0 mm. The large cap has a diameter of 6.2 mm and a height of 5.0 The Profection Healing Caps are designed with a 65° bevel which extends 0.5 mm mm. (small) to 0.7 mm (large) beyond the outer edge of the implant making it possible to modify the dimension of the caps.
| Article Number | 11151X | 11152X |
|---|---|---|
| Diameter | 5.8 mm | 6.2 mm |
| Height | 4.0 mm | 5.0 mm |
The following table shows the dimensions of the ITI Protection Healing Caps:
After the abutment has been placed into the implant, the clinician places the protection healing cap over the abutment. If necessary, after trying in the healing cap the clinician
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can remove the cap and modify it to the desired shape with a sandpager disc. This reshaping of the cap allows the clinician to achieve a precise shape which will maintain and condition the soft tissue contour necessary in the esthetic zone. If reshaped, it is recommended that the clinician then polish the protection cap. The cap is screwed into place over the abutment with an occlusal screw which is tightened to a recommended torque of 50 Ncm. At the final prosthesis delivery the profection cap is removed and disposed.
The ITI Protection Healing Caps are composed of Polyetheretherketone (PEEK) which is extruded from its granulated form and lathed to form the caps. The granulated form of PEEK is manutactured by Victrex Limited.
Intended Use of the Device 5.
The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the orgal cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.
Summary of Tethnological Characteristics of Device Compared to Predicate Devices 6.
| FEATURE | PROPOSEDDEVICE | PREDICATEDEVICES | |||
|---|---|---|---|---|---|
| IM ProtectionHealing Cap | NobelpharmaBrånemarkHealing Caps | CalcitekAbutmentComfort Caps | Interpore Int'lAbutmentSealing Caps | Steri-OssHealing Cap | |
| Intended UseTo protect theouterconfiguration ofthe abutmentand maintain andcondition softtissue. | Yes | Yes | Yes | Yes | Yes |
| Material | |||||
| Plastic | Yes | Yes | Yes | Yes | Yes |
| Design | |||||
| Diameter | 5.8 mm -6.2 mm | 4.5 mm -6.5 mm | 4.0 mm | 4.0 mm -6.0 mm | 3.8 mm |
| Height | 4.0 mm -5.0 mm | 2.7 mm | 5.0 mm | 2.0 mm | 3.0 mm |
| Placed over theabutment duringthe prostheticphase. | Yes | Yes | Yes | Yes | Yes |
§ 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.