(175 days)
No
The summary describes a physical dental implant and its intended use and design. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes.
The device is described as a dental implant intended for surgical placement to provide prosthetic attachment, which is a therapeutic intervention to restore dental function.
No
The device description indicates that 3i dental implants are intended for "surgical placement" to "provide a means for prosthetic attachment." This clearly describes a therapeutic or reconstructive function, not a diagnostic one. There is no mention of the device being used to identify or detect medical conditions.
No
The device description clearly states it is a physical dental implant made of materials and offered in various sizes and designs, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device for placement in the jaw to support dental prosthetics. This is a direct intervention on the patient's body.
- Device Description: The description details a physical implant made of materials designed for surgical placement and integration with bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is surgically implanted within the body for structural support.
N/A
Intended Use / Indications for Use
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 3i OSSEOTITE® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for external hex connections. Additionally, the implants are offered in a trans-gingival design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. size appropriate cover screws are offered with each implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, mandible
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Specific performance claims for enhanced performance in poor bone (K980549), early loading (K983347), and use in smokers (K022009), and immediate loading (K030164) have received market clearance based on the OSSEOTITE clinical data in the respective submissions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K874590, K935544, K972444, K980549, K983347, K992334, K014235, K022009, K030164, K033430, K051461
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).
Not Found
§ 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
K063286
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jacquelyn A. Hughes, RAC
Director, Regulatory Affairs & Quality Assurance
Implant Innovations, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6819
Fax. 561-514 6316
Email jhughes@3implant.com |
| Date Prepared | October 27, 2006 |
| Device Name | 3i OSSEOTITE® Dental Implants |
| Classification Name | Endosseous Dental Implants |
| Device Classification | Class II
Dental Devices Panel
21 CFR § 872.3640 |
| Predicate Devices | 3i OSSEOTITE Dental Implants
K874590, K935544, K972444, K980549, K983347,
K992334, K014235, K022009, K030164,
K033430, K051461 |
| Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act. |
| Device Description | The 3i OSSEOTITE® Dental Implants are provided
with the proprietary OSSEOTITE acid-etched surface
which has been in commercial distribution since market
clearance in 1995. Implants are offered in tapered and
parallel-walled/straight designs, each design providing
offerings for external hex connections. Additionally, the
implants are offered in a trans-gingival design with an
internal connection Implants are offered in diameters of
3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm
to 20 mm. size appropriate cover screws are offered with
each implant. |
| Indications for Use | 3i dental implants are intended for surgical placement in
the upper or lower jaw to provide a means for prosthetic
attachment in single tooth restorations and in partially or
fully edentulous spans with multiple single teeth, or as a
terminal or intermediary abutment for fixed or removable
bridework, and to retain overdentures. |
| | In addition, when a minimum of 4 implants, ≥ 10mm in
length, are placed in the mandible and splinted in the
anterior region, immediate loading is indicated. |
| Technological
Characteristics | The design features and functions are identical to the
currently available OSSEOTITE, OSSEOTITE NT®,
OSSEOTITE XP® and TG OSSEOTITE®, and 3i
Implant Innovations implants and cover screws. |
| Performance Testing | Laboratory testing was conducted to determine device
functionality and conformance to design input
requirements, as well as FDA's Class II special controls
guidance document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments. Risk
analysis was conducted in accordance with ISO 14971.
Specific performance claims for enhanced performance
in poor bone (K980549), early loading (K983347), and
use in smokers (K022009), and immediate loading
(K030164) have received market clearance based on the
OSSEOTITE clinical data in the respective submissions. |
| Conclusion | The 3i OSSEOTITE Dental Implants are substantially
equivalent to the dental implants described in the
premarket notification submissions for the predicate |
004 4
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Implant Innovations, Inc. 510(k) Premarket Notification -3i OSSEOTITE®Dental Implants
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Implant Innovations, Inc. 510(k) Premarket Notification -3i OSSEOTITE®Dental Implants
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:
devices K879450, K935544, K972444, K992334, K980549, K983347, K014235, K022009, K030164, K033430 , K051461.
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles three abstract human profiles or figures, stacked or layered on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2007
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K063286
Trade/Device Name: OSSEOTITE® Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 12, 2007 Received: April 13, 2007
Dear Ms. Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Hughes
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of Small Manufacturers. International 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. unne
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
5
Indications for Use
510(k) Number (if known): Ko 63286
Device Name: OSSEOTITE® Dental Implants
Indications for Use:
31 dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suarez
Hostolona, Canaral Hospical on Control, Den k) Number ..
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