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.

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K991822

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:
- ITI Dental Implant System® (K983742) .
- ITI Wide diameter Implant (K955281) .

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.

{2}------------------------------------------------

Summary of Technological Characteristics: 6.

Features	Subject DeviceAllfit®STI	Predicate Devices
		ITI Widediameter Implant(K955281)	ITI Dental ImplantSystem (K983742)
Intended Use	Implants intended to be placed in the maxillary and/or mandibulararch to support crowns, bridges or overdentures in edentulous &partially edentulous jaws
Indications for use	Implants used for all indications requiring oral endosseousimplants 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; 4.83.3 mm as option inalveolar ridges oflimited width	5.6	3.3; 4.1; 4.8
Endosseous Lengths	ShortNeck	LongNeck
	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 surgicalprotocol	Short NeckYES/NO	LongNeckYES	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.

{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

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 .

Indications for 3.3 mm ØSTI implants:

Indications for 4.8 mm ØSTI implants:

Prescription Use __
(Per 21 CFR 801.109)

Susan Rumsey

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dep 5 Ock) Number _

Regulation Number and Section

§ 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.