(80 days)
Not Found
No
The summary describes a physical dental implant and does not mention any software, algorithms, or AI/ML terms.
No.
The device, a dental implant, is intended to restore chewing function by providing a means for prosthetic attachment, which is a restorative purpose, not a therapeutic one.
No
The device is described as an implant for surgical placement to restore chewing function, which is a therapeutic purpose rather than a diagnostic one.
No
The device description clearly states it is an "internally connected, tapered implant," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the implants are for "surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function." This describes a surgical procedure and a device used within the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical characteristics and function of the implant itself, not on any reagents, instruments, or systems used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used in vivo (within the body) for a restorative purpose.
N/A
Intended Use / Indications for Use
The OSSEOTITE NT Certain Implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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)
Not Found
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.
K014235 - OSSEOTITE NT™ Dental Implants, K972444 - 3i Innovative Implants and Cover Screws, K935544 - Threaded Self-Tapping Threaded Implants, K980549 - OSSEOTITE Dental Implants, K983347 - OSSEOTITE Dental Implants, K022009 – 3i Dental Implants
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
JUL 288 2003
Implant Innovations, Inc. Thiplant Innovations, Inc.
510(k) Premarket Notification - OSSEOTITE NT™ CERTAIN™ Implants
Summary of Safety and Effectiveness
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 and Quality Assurance
Implant Innovations, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6819
Fax. 561-776-6852
Email jhughes@3implant.com |
| Date Prepared | May 8, 2003 |
| Device Name | OSSEOTITE NT™ CERTAIN™ Implants |
| Classification Name | Endosseous Dental Implant |
| Device Classification | Class III
Dental Devices Panel
21 CFR § 872.3640 |
| Predicate Devices | K014235 - OSSEOTITE NT™ Dental Implants
K972444 - 3i Innovative Implants and Cover Screws
K935544 - Threaded Self-Tapping Threaded Implants
K980549 - OSSEOTITE Dental Implants
K983347 - OSSEOTITE Dental Implants
K022009 – 3i Dental Implants |
| Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act. |
| Device Description | The OSSEOTITE NT Certain Implants are internally
connected, tapered implants designed to mimic the shape
and form of a natural tooth. |
1
| Indications for
Use | The OSSEOTITE NT Certain Implants are
indicated for surgical placement in the upper or lower jaw
to provide a means for prosthetic attachment to restore a
patient's chewing function. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The OSSEOTITE NT Certain Implants contain
features and functions which are similar to the currently
available OSSEOTITE NTTM Implants and 3i Innovative
Implants and Cover Screws. |
| Conclusion | The OSSEOTITE NT Certain Implants are substantially
equivalent to the legally marketed OSSEOTITE
NTImplants and 3i Innovative Implants and Cover Screws. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2003
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs Quality Assurance 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K031475
Trade/Device Name: Osseotite NTTM Certan™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 8, 2003 Received: May 9, 2003
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.
3
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Patricia Cuariteffer
Susan Runner, DDS, MA Interim 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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Page 1_ of 1
510(k) Number (if known): _K03/475
Device Name: OSSEOTITE NT™ CERTAIN™ Implants
Indications for Use:
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MKE for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Dev
510(k) Number: _
OR