The SIC pro System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SIC pro System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.

Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration. The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

Device Description

SIC pro System solid screw dental implants are root-form endosseous dental implant devices ono of of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.3 mm, ø4.2 mm, ø5.3 mm) and various length from 7.5 mm up to 16 mm. All ø3.3 mm diameter implants are cylindrical as well as the implants in diameter ø4.2 mm and ø5.3 mm in length of 7.5mm. All other implants in diameter ø4.2 mm and ø5.3 mm are partly tapered. The rength of 7.3mm. All other implants in acid etched for faster osseointegration and secondary stability.

The face side of the implant has a hexagon drill hole and a standard screw thread to ensure a The face side of the implant not a noxagon and the implant. Throughout the implant. Throughout the different diameters the hexagon drill hole has identical measurements.

SIC pro System Implants are delivered single packed in combination with a implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).

SIC pro System Abutments & Accessories are various in shape, length and diameters and made out of three different materials (titanium grade 5, implant steel 316L, zirconium oxide). Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.

SIC pro System Abutments & Accessories are supplied single packed in non-sterile condition. These parts of the system are intended to be sterilized by the user by and have been validated by These parts of the system are intoneed steam (autoclave) sterilization process (15 min., 136°C, 3 bar).

AI/ML Overview

This K040757 submission describes a dental implant system. The document is a 510(k) summary and subsequent FDA clearance letter, which means rather than a study with acceptance criteria and device performance as one might find for a novel device, it asserts substantial equivalence to predicate devices already on the market. Therefore, the information you're looking for will not be presented in the typical format of a new device study.

Here's an interpretation based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, direct "acceptance criteria" for performance are not explicitly stated in the document in the way they would be for a de novo device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the SIC pro System Dental Implants, Abutments, and Accessories are equivalent to the existing legally marketed predicate devices. The reported "performance" is that the device is substantially equivalent.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary Conclusion)
Device design and materials are comparable to predicate devices.	Composed of grade 4 titanium (implants) and titanium grade 5, implant steel 316L, zirconium oxide (abutments/accessories), similar to common materials in predicate devices.
Intended Use is the same as predicate devices.	Indicated for implantation in upper/lower jaw arches, single/multiple unit prosthetic attachment, and restoration of chewing function, consistent with predicate devices. Specific guidance for 3.3mm implants in narrow ridges provided.
Technological characteristics are similar to predicate devices.	Root-form endosseous dental implants, acid-etched surface, hexagon drill hole, various diameters/lengths, screw-retained/cementable options, sterile packaging (implants), non-sterile (abutments) for user sterilization. These features are common in the listed predicates.
Potential safety and effectiveness concerns are addressed and comparable to predicate devices.	The submission concludes "that the SIC pro System Dental Implants, Abutments and Accessories are equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act." This implies that any safety and effectiveness aspects would be comparable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) summary for substantial equivalence. It does not describe a clinical study or a test set with a specific sample size. The "data" used for comparison would be technical specifications, material properties, and intended use as compared to the predicate devices. There is no mention of country of origin of "data" in the context of a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is a substantial equivalence claim based on comparison to predicate devices, there isn't a "test set" requiring expert ground truth establishment in the traditional sense of a clinical or performance study. The "experts" involved are presumably the engineers and regulatory specialists who compiled the technical comparison and the FDA reviewers who assessed the submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring adjudication in this 510(k) submission.

5. 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 physical dental implant system, not an AI-powered diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a substantial equivalence submission is the features, materials, and intended use of the legally marketed predicate devices. The applicant needs to demonstrate that their new device shares these fundamental characteristics with the predicates, and that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned or relevant for this type of submission.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth to establish for it in this document.

Summary

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K04075-7

APR 1 3 2005

Implants from Implantologists

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K040757

SIC pro Dental Implant System

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

DATE: 2005-03-07

Establishment:

SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Registration Number: 3004443656

Official Correspondent:

Georg Schilli (CEO & Chairman) SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Phone: +41-61-2613966 Fax: +41-61-2613968 Email: georg.Schilli@sic-invent.com

Owner/Operator:

SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Owner/Operator Number: 9060857

US Agent:

MEDAGENT, Inc. Christa Heitmann-Franke One Park Ave, Suite #5G Hampton, 03842 NH Phone: 603-758-1029 Fax: 603-758-1029 Email: mail@sic-invent.com

Description of the Device 1.

1.1. Device Name & Classification

Common/Generic Device Name:	ENDOSSEOUS DENTAL IMPLANT, COMPONENTS & AC-CESSORIES
Classification Name:	IMPLANT, ENDOSSEOUS, ROOT-FORM
Trade Name:	SIC pro System, Dental Implants & Accessories
Regulation Number:	872.3640

1.2. Description of SIC pro System Implants

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Implants from Implantologists

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length of 7.5mm. All other implants in diameter ø4.2 mm and ø5.3 mm are partly tapered. The rength of 7.3mm. All other implants in acid etched for faster osseointegration and secondary stability.

SIC pro System Implants are delivered single packed in combination with a implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).

1.3. Description of SIC pro System Abutments & Accessories

Predicate Devices 2.

Straumann AG, ITI Dental Implant System®, K033984; u
FRIADENT GmbH, ANKYLOS® Dental Implant System, K040946;
Nobel Biocare USA Inc., Nobel Biocare Endosseous Iplants, K041661; .
Straumann AG, 1.5mm synOcta Abutment, K022859; .
Friadent GmbH, XIVE® TG Abutment, K032302. I

Indication for Use 3.

Patient's must be applicable for dental treatment with endosseous implants.

In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration.

The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

Conclusions 4.

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the informa-Dased on the uvaliders over that the SIC pro System Dental Implants, Abutments and Action provided from we squivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it and wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Public Health Service

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Georg Schilli Official Correspondent SIC Invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055

Re: K040757

Trade/Device Name: SIC pro System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 7, 2005 Received: April 11, 2005

Dear Mr. Schilli:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your securer researce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrstate conments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to devroes mar na nat (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the engistration, 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 II your device is classinod (See as 10) in a controls. Existing major regulations affecting (FMA), it may oc subject to sach adataf Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Oout nouncements concerning your device in the Eederal Register.

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Page 2 - Mr. Georg

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTS issualites or abat your device complies with other requirements mean that IDA has made a decement regulations administered by other Federal agencies. Of the Act of ally I oderal backed in requirements, including, but not limited to: registration Y ou must configry with an the Pisoeling (21 CFR Part 801); good manufacturing practice allo listing (21 OF R Part 807), abality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough finding of substantial equivalence of your device to a premarket notification. The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at no not your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K040757

Device Name: SIC pro System

Indications for Use:

YES___________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _NO (21 SFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sipa Rinsur

: .. IS on Sion-Off) uclaion of Anesthesiology, General Hospital Intection Control. Dental Devices 100k) 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.