(811 days)
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.
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.
Here's an analysis of the provided 510(k) summary, aiming to extract information about acceptance criteria and any supporting studies.
Important Note: The provided document is a 510(k) summary for a dental implant system (K991822). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a specific, controlled study in the same way a PMA (Premarket Approval) approval would. Therefore, the information related to acceptance criteria, specific studies, sample sizes, and ground truth will be largely absent or presented indirectly, focusing instead on comparison to the predicate.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The document doesn't explicitly list "acceptance criteria" for the device, as is common in a 510(k) where the focus is on comparing the new device to a legally marketed predicate device. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence. The device's performance is implicitly accepted if it performs similarly to the predicate. The "reported device performance" is primarily described by its material, design, and intended use being comparable to the predicate.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as described in the 510(k) Summary) |
|---|---|
| Intended Use: Placed in maxillary/mandibular arch to support crowns, bridges, overdentures in edentulous & partially edentulous jaws. | Allfit® STI: Implants intended for the same purpose. |
| Indications for Use: All indications requiring oral endosseous implants for functional, aesthetic rehabilitation. | Allfit® STI: Used for all indications as the predicate. Specifies use for single teeth replacement, bridge substitution, bracing for orthodontist regulation, and retention/support for dentures. |
| Material: Commercially Pure CP Titanium Grade 4 (as per predicate). | Allfit® STI: Commercially Pure CP Titanium Grade 4 (in conformity with ASTM standard F67). |
| Design: External screw threads with similar configuration to predicate (diameter, lengths, thread intervals). | Allfit® STI: Rotation symmetrical structure with thread, 75° orientation, available in 3.1, 4.1, 4.8mm diameters and 6 insertion lengths (7-17mm, or 8-18mm for long neck). |
| Sterility: Gamma Irradiation (as per predicate). | Allfit® STI: Gamma Irradiation, Co60. |
| Bone Integration Surface: Provides rough, bone-friendly surface for osseointegration (predicate uses TPS coating). | Allfit® STI: Mechanically shaped and sandblasted surface to significantly improve bone growth. Claims sandblasting offers assurance for a rough, cave-free surface, contrasting it favorably with potential issues with TPS coating. |
| Mechanical Strength: Sufficient for intended use (implicitly comparable to predicate). | Allfit® STI: The 3.3mm diameter implants are noted to have lower mechanical strength and should only be used for indications with minimal loading. Otherwise, not explicitly quantified but implied to be sufficient for general use. |
| Surgical Protocol Compatibility: One-stage and two-stage procedures. | Allfit® STI: Short neck suitable for both one and two-stage. Long neck for single-stage, with rare possibility for two-stage. |
No specific acceptance criteria metrics (e.g., success rate, fracture resistance values) are provided beyond the functional description and comparison to predicate devices.
Study Information:
Based on the provided K991822 510(k) summary, there is no detailed study information provided that would directly prove the device meets specific acceptance criteria in a quantitative manner. The submission relies heavily on substantial equivalence to predicate devices.
1. Sample sized used for the test set and the data provenance:
- None explicitly stated. The submission is a regulatory filing for substantial equivalence, not a report on a clinical trial or performance study with a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set requiring ground truth establishment by experts is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental implant, not an AI-driven diagnostic tool. No MRMC study or AI component is mentioned.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No specific "ground truth" for a performance study is described. The "ground truth" for a 510(k) is effectively the performance and safety history of the predicate device.
7. The sample size for the training set:
- Not applicable. This device is a physical dental implant, not a software algorithm requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable. See point 7.
Summary of Substantial Equivalence Basis:
The core of this 510(k) submission is the comparison of the Allfit® STI System to the legally marketed predicate devices: ITI Dental Implant System® (K983742) and ITI Wide diameter Implant (K955281).
The applicant argues substantial equivalence based on:
- Similarities in: Intended use, indications for use, material composition (CP Titanium Grade 4), sterility method (Gamma Irradiation), abutments, accessories, and target population.
- Design Similarities: External screw threads, screw diameters, thread heights and rises, similar lengths.
- Differences and how they don't raise new safety/effectiveness concerns:
- Surface Treatment: Allfit® STI uses mechanical shaping and sandblasting, while the predicate ITI system uses a Titanium Plasma Sprayed (TPS) coating. The applicant argues sandblasting offers a "rough, cave-free surface," implying it is at least equivalent to, if not safer than (due to potential "caves and niches" with TPS), the predicate's surface.
- Implant Grip/Packaging: The Allfit® STI is produced with a small grip that is broken off, leaving a non-treated rise. This is presented as a method appreciated by dentists for secure functioning and avoiding contact with other materials, implying no new safety issues compared to the predicate's method (implant hangs within a Titanium husk ring).
- Neck Heights: Allfit® STI offers two neck heights (1.8mm and 2.8mm, leading to different endosseous lengths) and discusses their suitability for one- or two-stage procedures, differentiating from the predicate but arguing for clinical utility without introducing novel risks. The short neck is explicitly noted to make it easier to cover the implant for a two-stage procedure.
The FDA's letter (AUG 15 2001) confirms that they found the device to be substantially equivalent FOR THE INDICATIONS FOR USE referenced in the submission. This means the FDA accepted the manufacturer's arguments that the differences between the Allfit® STI and the predicate devices do not raise different questions of safety and effectiveness.
§ 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.