(125 days)
ITI Large Closure Screw, Branemark Healing Abutments, Steri-Oss Healing Abutments, Implant Innovations' Healing Abutments
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven aspects. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an esthetic healing cap used post-implant placement to protect the implant, maintain soft tissue, and aid in esthetic results, rather than to treat or diagnose a disease or condition.
No
The device description indicates that the esthetic healing caps are titanium devices used to protect implants and stabilize soft tissue during the healing phase, not to diagnose any condition or disease.
No
The device is described as a physical titanium device (healing cap) with an occlusal screw, clearly indicating it is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a physical implant component (esthetic healing cap) used in vivo (within the body) during the healing phase after dental implant placement. Its purpose is to protect the implant, shape soft tissue, and aid in the healing process.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information. It is a therapeutic and protective device.
Therefore, the esthetic healing cap falls under the category of a medical device used for treatment and healing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The esthetic healing caps are intended to protect the inner configuration of the M implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft fissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.
Product codes
Not Found
Device Description
The ITI esthetic healing caps are titanium devices which are mounted onto an ITI implant before the soft tissue is sutured in place around the implant. These healing caps are intended to protect the inner configuration of the ITI implant and the 45s outer shoulder of the implant during the healing phase after the placement of the implant. The esthetic healing caps also serve to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing caps 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 esthetic healing cap remains in place for six to twelve weeks.
The ITI esthetic healing cap is available in two heights (2.0 mm and 3.5 mm). Each cap consists of two parts: the body of the healing cap itself and a corresponding occlusal screw which aftixes the cap onto the implant. The healing caps and the occlusal screws are composed of commercially pure Grade 4 titanium meeting ASTM F67-95.
The esthetic healing caps are designed with a bevel which should be positioned either labially or bucally. This bevel enables positioning of the mucoperiosted! flap over the esthetic healing cap after implant placement without subjecting the flap to tension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral esthetic zone
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ITI Large Closure Screw, Branemark Healing Abutments, Steri-Oss Healing Abutments, Implant Innovations' Healing Abutments
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.
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
ATTACHMENT 7 - 510(k) Summary
Applicant's Name and Address 1.
JUN 1 8 1996
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. Carolyn M. Bitetti, Director, Regulatory Affairs Summary prepared January 23, 1996
2. Name of the Device
Trade Name: ITI Esthetic Healing Caps Common Name: Healing cap or healing abutment Classitication Name: Accessory to a dental implant (21 CFR 872,3640)
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
- ITI Large Closure Screw 1.
- Branemark Healing Abutments 2.
-
- Steri-Oss Healing Abutments
- র্ব Implant Innovations' Healing Abutments
র্ব Description of the Device
The ITI esthetic healing caps are titanium devices which are mounted onto an ITI implant before the soft tissue is sutured in place around the implant. These healing caps are intended to protect the inner configuration of the ITI implant and the 45s outer shoulder of the implant during the healing phase after the placement of the implant. The esthetic healing caps also serve to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing caps 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 esthetic healing cap remains in place for six to twelve weeks.
The ITI esthetic healing cap is available in two heights (2.0 mm and 3.5 mm). Each cap consists of two parts: the body of the healing cap itself and a corresponding occlusal screw which aftixes the cap onto the implant. The healing caps and the occlusal screws are composed of commercially pure Grade 4 titanium meeting ASTM F67-95.
The esthetic healing caps are designed with a bevel which should be positioned either labially or bucally. This bevel enables positioning of the mucoperiosted! flap over the esthetic healing cap after implant placement without subjecting the flap to tension.
1
Intended Use of the Device ನ.
The esthetic healing caps are intended to protect the inner configuration of the M implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft fissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.
Summary of Technological Characteristics of Device Compared to Predicate 6. Devices
| Predicate Devices | ||||
|---|---|---|---|---|
| Feature | ITI Large Closure | |||
| Screw | Brånemark | |||
| Healing | ||||
| Abutments | Implant | |||
| Innovations | ||||
| Healing | ||||
| Abutments | Steri-Oss | |||
| Healing | ||||
| Abutments | ||||
| Intended Use | ||||
| To form, | ||||
| stabilize, and | ||||
| maintain the | ||||
| soft tissue. | YES | YES | YES | YES |
| Material | ||||
| Titanium | YES | YES | YES | YES |
| Design | ||||
| Diameters | ||||
| (mm) | 6.0 mm | 5.0 mm | 4.5 mm - | |
| 7.5 mm | 3.5 mm - | |||
| 6.0 mm | ||||
| Heights | ||||
| (mm) | 1.5 mm | 3.0 mm - | ||
| 7.0 mm | 2.0 mm - | |||
| 8.0 mm | 5.0 mm - | |||
| 7.0 mm | ||||
| Inserted directly | ||||
| into the implant | ||||
| during soft | ||||
| tissue healing | ||||
| period. | YES | YES | YES | YES |