Support of fixed (cemented) restorations utilizing multiple abutments;
Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
Terminal or intermediate abutment support for fixed bridgework;
Free standing restorations without involvement of adjacent dentition when the external hex is engaged.

Device Description

The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc.

AI/ML Overview

The Bio Science Technologies, Inc.'s Icon Implant System gained 510(k) clearance by demonstrating substantial equivalence to the legally marketed predicate device, the Branemark System® Mk II Self-Tapping Fixture (K945398). The submission relies on a comparison of characteristics rather than a study with acceptance criteria and measured performance.

Here's an analysis of the provided information, addressing your points:

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

Since this is a substantial equivalence submission, there aren't explicit "acceptance criteria" in terms of performance metrics with thresholds, nor is there "reported device performance" in the traditional sense of a study measuring clinical outcomes. Instead, the "acceptance criterion" is a demonstration of substantial equivalence to a predicate device.

Characteristic/Comparison Point	Predicate Device (Branemark System® Mk II Self-Tapping Fixture)	Icon Implant System (reported "performance" relative to predicate)
Intended Use	To be surgically placed in the bone of the upper and the lower jaw arches to provide support for prosthetic devices such as artificial teeth and to restore the patient's chewing function.	Identical to predicate: Support of fixed (cemented) restorations, fixed detachable (screw retained) prosthetics, overdenture retention, terminal/intermediate abutment support for fixed bridgework, free-standing restorations.
Material	Commercially-pure titanium grade 1	Commercially-pure titanium grade 3 or 4
Diameters (mm)	3.75	3.3, 3.75, 4.0
Lengths (mm)	10, 13, 15, 18	7, 8, 10, 13, 15, 18
Design (Polished Collar)	Present	Present
Design (Self-Tapping)	Present	Present
Design (External Hex)	Present	Present
Design (Passivated)	Present	Present
Basic Features	Endosseous implant, osseointegration	Endosseous implant, osseointegration (identical)
Surgical Protocols	Similar	Similar
Healing Period Routine	Same	Same

Conclusion on Equivalence: The submission asserts substantial equivalence based on the similarities in intended use, design principles, material (both commercially-pure titanium), and similar surgical/healing protocols. Differences in grades of titanium (grade 1 vs. 3 or 4) and ranges of diameters/lengths were presented as minor differences that do not raise new questions of safety or effectiveness.

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

There was no test set as described for performance evaluation. This submission is a comparison to a predicate device. The data provenance is a description of the proposed device and a comparison to the predicate device's specifications.

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. No ground truth was established by experts for a test set in this context. The "ground truth" for the comparison was the specifications and intended use of the predicate device, which was already cleared by the FDA.

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

Not applicable. No test set was used requiring adjudication.

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 is a medical device (dental implant), not a diagnostic AI system, and no MRMC study was conducted.

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

Not applicable. This is a medical device (dental implant), not an algorithm.

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

The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of the predicate device, Branemark System® Mk II Self-Tapping Fixture (K945398), and its established specifications and clinical performance, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. No "training set" was used as this is not an AI/machine learning device.

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

Not applicable. The concept of a "training set" and its ground truth establishment is not relevant to this type of device clearance.

Summary

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Ka74106

JUN 1998

510(k) SUMMARY [21 CFR 807.92(c)] XIV.

Applicant name:

Bio Science Technologies, Inc. 3639 Harbor Boulevard, Suite #121 Ventura, CA 93001 (805) 677-4920 (805) 677-4922 (fax)

Contact Person: Mr. Sergio F. Cifuentes, President Date Summary Prepared: October 30, 1997

DEVICE NAME

Icon Implant System Trade Name: Common Name: Dental Implant Classification Name: Endosseous Implant

THE PRODUCT AND ITS INTENDED USE

Support of fixed (cemented) restorations utilizing multiple abutments;
Support of fixed detachable (screw retained) prosthetics utilizing multiple . abutments;
Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
Terminal or intermediate abutment support for fixed bridgework;
. Free standing restorations without involvement of adjacent dentition when the external hex is engaged.

Premarket Notification Submission Bio Science Technologies, Inc.

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DIAMETERS (in mm.)	LENGTHS (in mm.)
3.3	8	10	13	15
3.75	8	10	13	15	18
4	7	10	13	15	18

TABLE #1 -- ICON IMPLANT SYSTEM

Composition of Finished Device:

The Icon Implant System is manufactured from commercially-pure titanium grade 3 or 4.

Premarket Notification Submission Bio Science Technologies, Inc.

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ATTRIBUTES	Icon Implant System	Branemark System® MkII Self-Tapping Fixture
Intended Use	The Icon Implant System isintended for use in eitherpartially or fully edentulousmandibles and maxillae in thefollowing areas:• Support of fixed (cemented)restorations utilizing multipleabutments;• Support of fixed detachable(screw retained) prostheticsutilizing multiple abutments;• Overdenture retention bymeans of a ball overdentureattachment, o-ring attachment,dalla bona, or hader bar;• Terminal or intermediateabutment support for fixedbridgework;• Free standing restorationswithout involvement ofadjacent dentition when theexternal hex is engaged.	The Branemark System®Mk II Self-Tapping Fixtureis intended for use to besurgically placed in thebone of the upper and thelower jaw arches to providesupport for prostheticdevices such as artificialteeth and to restore thepatient's chewing function.
Material	Commercially-pure titaniumgrade 3 or 4	Commercially-pure titaniumgrade 1
Diameters (mm)	3.3, 3.75, 4.0	3.75
Lengths (mm)	7, 8, 10, 13, 15, 18	10, 13, 15, 18
Design	Polished Collar	Polished Collar
Design	Self-Tapping	Self-Tapping
Design	External Hex	External Hex
Design	Passivated	Passivated

TABLE #2 -- TABLE OF SUBSTANTIAL EQUIVALENCE

STATEMENT OF SUBSTANTIAL EQUIVALENCE

Bio Science Technologies, Inc. considers the Icon Implant System to be substantially equivalent to FDA-cleared devices marketed by other dental product manufacturers.

Premarket Notification Submission
Bio Science Technologies, Inc.

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SUMMARY OF SUBSTANTIAL EQUIVALENCE

Both the Icon Implant System and the Branemark System® Mk II Self-Tapping Fixture 510(k) (reference number K945398) are substantially equivalent with respect to the following characteristics:

Both devices are endosseous implants which work through osseointegration. 1.
They have the same indications for use. Please refer to page 24, Table #2 -2. Table for Substantial Equivalence.
Both devices utilize the same design principles. 3.
Both devices are made of the same material, commercially-pure titanium. 4.
న. Both devices are implanted using similar surgical protocols.
Both devices require that the same routine be followed during the healing 6. period following the implantation.

As the above list of similarities indicates, the Icon Implant System and the Branemark System® Mk II Self-Tapping Fixture have the same basic features. Furthermore, both devices are indicated for similar purposes. Therefore, the Icon Implant System and the Branemark System® Mk II Self-Tapping Fixture are substantially equivalent.

Performance Data:	N/A
Nonclinical Data:	N/A
Clinical Data:	N/A

-- END OF 510(k) SUMMARY --

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an emblem featuring a stylized eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The seal appears to be a black and white image.

JUN 1 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio Science Technologies, Incorporated C/O Alan Donald, MS, MBA, RAC Consultant to Bio Science Technologies, Incorporated Pacific Regulatory Services, Incorporated (PRSI) The Aventine Office Building 8910 University Center Lane, Suite 265 San Diego, California 92122-1085

Re : K974106 Icon Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: January 19, 1998 January 20, 1998 Received:

Dear Mr. Donald:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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 of the Act. The general controls provisions of the Act include requirements 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨੇ substantially equivalent determination assumes compliance with the Good Manufacturing 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 regulation may result in 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Donald

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one regaracion Chisation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://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

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Page

510(k) Number (if known): K974106

Device Name: ICON Implant System

Indications For Use:

Device Description/Intended Use:

The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual to implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc. The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:

Support of fixed (cemented) restorations utilizing multiple abutments; .
Support of fixed detachable (screw retained) prosthetics utilizing multiple . abutments;
Overdenture retention by means of a ball overdenture attachment, o-ring . attachment, dalla bona, or hader bar;
Terminal or intermediate abutment support for fixed bridgework; .
Free standing restorations without involvement of adjacent dentition when the external hex is engaged.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ountainable

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.