(213 days)
Not Found
No
The document describes a dental implant system and does not mention any AI or ML components or functionalities.
No
The device is an implant system used for supporting dental prosthetics in edentulous areas, which is a restorative rather than therapeutic function.
No
The document describes the Icon Implant System as a screw implant and cover screw intended for use in mandibles and maxillae to support various dental restorations. Its intended use is for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system consists of a screw implant and a cover screw, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in supporting dental prosthetics within the human body (mandibles and maxillae). This is a surgical/implantable device, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a screw implant and cover screw, which are physical components implanted into bone. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Icon Implant System is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: N/A
Nonclinical Data: N/A
Clinical Data: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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
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
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. 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.
Premarket Notification Submission Bio Science Technologies, Inc.
1
| 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.
2
| ATTRIBUTES | Icon Implant System | Branemark System® Mk
II Self-Tapping Fixture |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The Branemark System®
Mk II Self-Tapping Fixture
is intended for 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. |
| Material | Commercially-pure titanium
grade 3 or 4 | Commercially-pure titanium
grade 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. |
3
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 --
4
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
5
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
6
Page
1
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)
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