(811 days)
Not Found
No
The document describes a physical dental implant and its intended use, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant used for functional and aesthetic rehabilitation, not for treating a disease or condition in a therapeutic manner.
No
Explanation: The device is an oral endosseous dental implant designed for functional and aesthetic rehabilitation, not for diagnosing medical conditions. The document mentions "preoperative diagnostics" but clarifies that these diagnostics precede the use of the Allfit® STI implants, indicating the implants themselves are not diagnostic.
No
The device description clearly describes physical dental implants made of titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Allfit® STI implants are screw-type endosseous dental implants made of titanium. Their intended use is for the functional and aesthetic rehabilitation of edentulous and partially dentate jaws by being surgically implanted into the bone.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens from the patient. It is a physical implant placed within the body.
Therefore, the Allfit® STI implants fall under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP Titanium Grade 4. Provided the existence of adequate bone supply in terms of bone quality, bone width and height, Allfit® STI implants can be used for all indications requiring oral endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise:
- Single teeth replacement for gaps up to the width of Incisive and Premolars .
- Bridge substitution in edentulous, partially or fully dentate jaws .
- Bracing for orthodontist regulation systems .
- Providing retention and support for dentures through bars and/or ball attachment .
The implants must be used only in conjunction with the associated original components and instruments of the system according to the indications and recommendations of Dr. Ihde Dental AG. The surgical procedures must be preceded by a comprehensive and thorough patient evaluation, preoperative diagnostics, and treatment planning.
Indications for 3.3 mm ØSTI implants:
STI screw implants with an external diameter of 3.3 mm are considered options for placement in alveolar ridges of limited width (5-6 mm). Since the 3.3 mm diameter STI implants exhibit lower mechanical strength values compared to the 4.1 mm and 4.8 Ø STI implants, the 3.3 mm diameter screw implants should only be used for indications involving minimal loading.
Indications for 4.8 mm ØSTI implants:
4.8 mm Ø STI screw implants can be used for all indications requiring oral, endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws with a width of 7 mm or more.
It is recommended to always use the longest and widest (diameter) implant. Hereby the possibly influencing forces must be taken into account. It is therefore recommended, not to use implants with small diameters in the posterior side for single teeth implantation. The anatomical and prosthetic conditions have to be taken into consideration.
For a proper use of the STI implants, the consultation of The Allfit® STI instructions for use, provided by Dr. Ihde Dental AG, including the list of absolute, relative and local contraindications, is absolutely indispensable.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The implants, produced from CP titanium 4, are available is in three diameters (3.1; 4.1 and 4.8 mm) and 6 insertion lengths: (7, 9, 11, 13, 15 and 17) respectively (8, 10, 12, 14, 16 and 18 for the long neck STI implants). The neck of the implant, which remains above the bone crest after the implantation, is a smooth machined surface to permit the attachment of epithelial tissue.
The STI implants are characterized through a rotation symmetrical structure with a thread showing high thread intervals. The thread interval depends on the implant diameter: 1 mm for the implants of 3.3 mm diameter, and 1.25 mm for the implants of 4.1 and 4.8 mm diameter. The main feature of the thread form is the 75° orientation of the surface of the thread to the implant axis, rather than parallel to the implant axis, and so directing compressive forces into the bone.
The outside contact area between the implant and its abutment shows a slope of 45° to maximize prosthesis stability, otherwise this area is flat. The implant does not possess any inside or outside hex. The rotation secured screw (against the abutment) occurs over the friction of the inside cone, hereby the inside screw thread M2 pulls against the cone. The creation of high adhesion friction fit leads to a secure connection of implant and abutment. Single crowns can be screwed on the implant, if secured abutments (for example OSA STI) are used.
Allfit STI-implants are available in two neck heights: 1.8 mm and 2.8 mm, however the total length of the implant is always identical. Therefore the endosseous part is smaller in the case of 2.8mm neck height. The choice between the 2 alternatives depend on the clinical situation of the soft tissue: In the molar region, thick soft tissues are usually suitable for the long neck, while in the anterior region, esthetic aspects and thin soft tissue are suitable for smaller neck portions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray-examination by means of Orthopantomogram as well as, if necessary remote x-ray and/or CT-examination.
Anatomical Site
Maxillary and/or mandibular arch, edentulous and partially edentulous jaws, upper or lower jaws.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists, as implied by statements such as "appreciated by the practicing dentists".
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)
Not Found
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.
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
510(k) Summary
Introduction:
The following is a summary of Safety and Effectiveness Information. It has been prepared The Iollowing is a summary of Barey and sates and sales of the Food and Drug diffective in the Ungmation regarding safety and/or efficiency has been deleted from that submission, for this summary.
Applicant's Name and Address: 1.
Dr. Ihde Dental AG Switzerland Lindenstrasse 68 8738 Uetliburg Switzerland
| Telephone Number: | +41 55 280 38 07 |
|---|---|
| Fax Number: | +41 55 280 38 61 |
Dr. Stefan Thde: Contact Person: May 20, 1999 Summary Prepared:
Name of the Device: 2.
Allfit® STI System Trade Name: Dental Implant System Common Name: Endosseous Implant (21 CFR 872.3640, Class III device). Classification Name:
- Predicate Device: Legally Marketed Devices to which Significant Equivalence SE 3. is claimed:
Intended use of the device 4.
The Allfit® STI implants are screw type endosseous dental implants made of The Allines BTF implants are re. Grade 4 in conformity with ASTM standard connification F67. An adequately osseointegrated implant will result in a firm and specification 1 07. Par were the specifically treated titanium surface and the living bone. The STI implants are intended to be placed in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous and partially edentulous aren to support crownle, orrages or sere indicated for use in areas with adequate bone Jaws of patients. The DIT miphans as width and height. This also includes posterior areas with sufficient transverse bone and limited vertical bone height.
The implants must be used only in conjunction with the associated original The miplants mass of the system according to the indications and components and interact of Dr. Ihde Dental AG. Besides the STI implants, the system includes surgical and prosthetic instruments as well as abutments. The surgical mondos surgious and probactive and thorough patient evaluation,
1
preoperative diagnostics, and treatment planning. The diagnostics consists of prooperais, clinical examination, x-ray-examination by means of Orthopantomogram as well as, if necessary remote x-ray and/or CT-examination.
Description of the device ડ.
The implants, produced from CP titanium 4, are available is in three diameters (3.1; 4.1 and 4.8 mm) and 6 insertion lengths: (7, 9, 11, 13, 15 and 17) respectively (8, 10, 12, 14, 16 and 18 for the long neck STI implants). The neck of the implant, which remains above the bone crest after the implantation, is a smooth machined surface to permit the attachment of epithelial tissue.
The STI implants are characterized through a rotation symmetrical structure with a thread showing high thread intervals. The thread interval depends on the implant diameter: 1 mm for the implants of 3.3 mm diameter, and 1.25 mm for the implants of 4.1 and 4.8 mm diameter. The main feature of the thread form is the 75° orientation of the surface of the thread to the implant axis, rather than parallel to the implant axis, and so directing compressive forces into the bone.
The outside contact area between the implant and its abutment shows a slope of 45° to maximize prosthesis stability, otherwise this area is flat. The implant does not possess any inside or outside hex. The rotation secured screw (against the abutment) occurs over the friction of the inside cone, hereby the inside screw thread M2 pulls against the cone. The creation of high adhesion friction fit leads to a secure connection of implant and abutment. Single crowns can be screwed on the implant, if secured abutments (for example OSA STI) are used.
Allfit STI-implants are available in two neck heights: 1.8 mm and 2.8 mm, however the total length of the implant is always identical. Therefore the endosseous part is smaller in the case of 2.8mm neck height. The choice between the 2 alternatives depend on the clinical situation of the soft tissue: In the molar region, thick soft tissues are usually suitable for the long neck, while in the anterior region, esthetic aspects and thin soft tissue are suitable for smaller neck portions.
2
Summary of Technological Characteristics: 6.
| Features | Subject Device
Allfit®STI | Predicate Devices | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------|
| | | ITI Wide
diameter Implant
(K955281) | ITI Dental Implant
System (K983742) |
| Intended Use | Implants intended to be placed in the maxillary and/or mandibular
arch to support crowns, bridges or overdentures in edentulous &
partially edentulous jaws | | |
| Indications for use | Implants used for all indications requiring oral endosseous
implants for functional, aesthetic rehabilitation of edentulous &
partially dentate upper or lower jaws | | |
| Material | Commercially Pure CP Titanium Grade 4 | | |
| Design | External screw threads | | |
| External screw threads | 75° orientation to the implant axis | | |
| Diameter | 3.3; 4.1; 4.8
3.3 mm as option in
alveolar ridges of
limited width | 5.6 | 3.3; 4.1; 4.8 |
| Endosseous Lengths | Short
Neck | Long
Neck | |
| | 7.0 | 8.0 | 8.0 |
| | 9.0 | 10.0 | 10.0 |
| | 11.0 | 12.0 | 12.0 |
| | 13.0 | 14.0 | 14.0 |
| | 15.0 | 16.0 | 16.0 |
| | 17.0 | 18.0 | |
| Sterility | Gamma Irradiation, Co60 | | |
| One stage surgical
protocol | Short Neck
YES/NO | Long
Neck
YES | YES |
| Implant/abutment taper | YES | | YES |
| External Hex | NO | | NO |
| TPS coating | NO | | YES |
| Sand Blasting | YES | | NO |
·
:
3
Basis for Substantial Equivalence
The Allfit® STI implant system is significantly equivalent to the cleared, Straumann ITI Implant System (K955281, K983742). The STI implant system is in terms of 111 miliplain bybolif (11/1/2011 thickness, screw diameters, screw thread heights & rises), material composition, sterility method, intended use, abutments, accessories, indications for use and target population, very similar to the cleared Straumann ITI system.
The endosseous surface of the STI implants is first mechanically shaped, then cleaned The choossoous surface of this surface treatment method enables the increase and said blusiou with i with significantly improve the grow of the bone after the implantation. In contrast to the STI implants, the cleared Straumann ITI implant mipunanted into the bone has an anchorage surface of a Titanium Plasma poraved TPS coating of 20-30 um thickness. This process yields also to very rough, bone friendly implant surfaces. In contrast to the sand blasting method (STI), the TPS method is complex and technically sensible. If this method is not conducted adequately, this may lead to undesired caves and niches within the surface of the implant. If this occurs, it is possible, that these caves and niches can not be cleaned effectively and therefore could offer a good substratum for bacteria. In this respect, the sand blasting method offers the assurance for a rough, cave-free surface.
The STI implants are produced in one single piece with a small grip, which is then locked into the cover of the primary packaging. Before the actual implantation, the iooked this first screwed on the insertion tool and then broken off from its grip. After breaking the grip, a non treated rise of pure Titanium with approximately 0.6 mm diameter and 0.2 mm height remains on the break off area of the implant. This method has been appreciated by the practicing dentists, because it enable a secure functioning and permit to avoid any contact with other materials or substances. In the case of the and permis to a volu ants, the implant hangs within a Titanium husk ring, separating the implant from the packaging material.
The Allfit STI RT LN (long neck) implants are intended, - similar to the previously cleared Straumann ITI-Implants-, for single stage protocols. However, in rare cases, it may be possible to cover the tissue over the long neck and change the procedure to two stages. The Allfit STI short neck implants show a sand blasted surface, which is 1 mm longer than the long neck type. This leads to a shorter neck: instead of 3,3 mm the total neck portion is 2.3 mm only. Consequently it is easier to cover the implant after placement with soft tissue and change the protocol to a two stage procedure. In general, with the short neck, Allfit STI RT implant, are suitable for both types of surgery: One and two stage. The short neck makes it easier to cover the implant after placement .
Premarket Notification Certification and Summary: 8.
I certify, in my capacity as Chief Executive Officer of Dr. Ihde Dental AG, that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the Allfit® STI implants. I further certify that I am aware of the types of problems to which the Allfit® STI implants are susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness about the Allfit® STI implants is complete and accurate.
44
4
Failure to osseointegrate or loss of osseointegration can be caused by:
- Improper patient selection, patients with systemic diseases which affect bone . physiology, patients with habits such as bruxing or clenching, patients who are physically or psychologically unable to carry out proper implant hygiene, patients with heavy smoking or alcohol use.
- Improper surgical technique such as overheating of bone. .
- Improper case planning or restorative technique: Overloading of implants through . improper placement, Use of an insufficient number of implants or excessive cantilever.
- Improper implant processing by the manufacturer, improper handling by the . dentist resulting in contamination.
Fracture of implants can occur either on insertion of screw type implants due to excessive torque (improper surgical technique such as an error in drill selection) or in service due to loss of bone.
Fracture of abutments and abutment screws occurs in implant systems and is usually attributed to factors within the control of the implant team, such as lack of passive fit of the restoration or excessive cantilever, or within the control of the patient, such as bruxing.
There are other types of safety and effectiveness problems which have beer observed for endosseous dental implant systems. These are:
- local soft tissue degeneration and bone resorption .
- paresthesia .
- perforation of the maxillary sinus, perforation of labial and lingual plates ●
- local and systemic infection .
- prosthetic framework fracture, bone fracture .
- nerve injury, injury to adjacent teeth and their supporting bone .
- . oroantral or oronasal fistula
- . gingival hyperplasia
- soft tissue overgrowth .
- perforation of the gingiva by the healing screw .
- . mucosal abscess
- displacement of the implant into the mandibular canal .
- hemorrhage of the floor of the mouth due to transection of the sublingual artery and . breakage of drill tip, requiring surgical removal.
May 24, 1999.
Dr. Stefan K. Ihde
Chief Executive Officer
Dr. Ihde Dental AG
5
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
AUG 1 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Mourad Baraket Carthago International Solutions, Inc. 70 Battery Place Riverwatch Suite 406 New York, New York 10280
Re : K991822 Allfit Implant System, Short Neck, Model ST1 Trade Name: Rt Length, AL Requlatory Class: İİİ Product Code: DZE September 20, 1999 Dated: Received: September 22, 1999
Dear Mr. Baraket:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the device forly equivalent (for the indications for device in babbandaa----------------------------------------------------------------------------------------------------------------------------------------------------------commerce prior to May 28, 1976, the enactment date of the commerce price Amendments, or to devices that have been redical beview in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. or the nee? The gon for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be bayeer to Bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancially of Squaring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif bach abbambellin regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
6
Page 2 - Mr. Baraket
obligation you might have under sections 531 through 542 of obligation you might have ander betronic Product Radiation the Act for devices ander one ederal laws or regulations.
This letter will allow you to begin marketing your device as This lecter will arrow you co xxx motification. The FDA described in your SIUTAT prematics of your device to a legally finding of substancial equivalier of a classification for your marketed predicate device robates as a soceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (301) 354 1032. of your device, please contact the Dromocion and adversibility of JS-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the DIVISION OF BMari Handr (300) 443-6597 or at at its corr-free namber (s://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K991822 510(K) Number:
Device Name:
Allfit STI Implant System
Indications for Use
The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP Titanium Grade 4. Provided the existence of adequate bone supply in terms of bone quality, bone width and height, Allfit® STI implants can be used for all indications requiring oral endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise:
- Single teeth replacement for gaps up to the width of Incisive and Premolars .
- Bridge substitution in edentulous, partially or fully dentate jaws .
- Bracing for orthodontist regulation systems .
- Providing retention and support for dentures through bars and/or ball attachment .
The implants must be used only in conjunction with the associated original components and instruments of the system according to the indications and recommendations of Dr. Ihde Dental AG. The surgical procedures must be preceded by a comprehensive and thorough patient evaluation, preoperative diagnostics, and treatment planning.
Indications for 3.3 mm ØSTI implants:
STI screw implants with an external diameter of 3.3 mm are considered options for placement in alveolar ridges of limited width (5-6 mm). Since the 3.3 mm diameter STI implants exhibit lower mechanical strength values compared to the 4.1 mm and 4.8 Ø STI implants, the 3.3 mm diameter screw implants should only be used for indications involving minimal loading.
Indications for 4.8 mm ØSTI implants:
4.8 mm Ø STI screw implants can be used for all indications requiring oral, endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws with a width of 7 mm or more.
It is recommended to always use the longest and widest (diameter) implant. Hereby the possibly influencing forces must be taken into account. It is therefore recommended, not to use implants with small diameters in the posterior side for single teeth implantation. The anatomical and prosthetic conditions have to be taken into consideration.
For a proper use of the STI implants, the consultation of The Allfit® STI instructions for use, provided by Dr. Ihde Dental AG, including the list of absolute, relative and local contraindications, is absolutely indispensable.
Prescription Use __
(Per 21 CFR 801.109)
Susan Rumsey
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dep 5 Ock) Number _
46