(104 days)
Not Found
No
The summary describes a physical dental implant with a specific surface treatment and design variations. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on laboratory testing and risk analysis related to the physical device.
Yes
The device is a dental implant, which is surgically placed in the jaw to provide a base for prosthetic attachments, serving a therapeutic purpose by replacing missing teeth or supporting dental work.
No
The device is described as dental implants intended for surgical placement and prosthetic attachment, which are treatment modalities, not diagnostic ones.
No
The device description clearly indicates it is a physical dental implant made of materials and with specific surface treatments and designs, 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 describes a device for surgical placement in the jaw to support dental prosthetics. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics and surface treatment of a dental implant, which is a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant, not an IVD.
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, ≥ 10 mm in length, arc placed in the maxilla and/or 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 Nano CaP OSSEOTITE Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nano-crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled /straight designs, and each design provides offerings for either external hex or internal connections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, maxilla and/or the 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 indut requirements, as well as FDA's Class II Special Controls Root-form Endosseous Dental Document: Guidance Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971.
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, K972444, K935544, K980549, K983347, K022009, K955428, K031475, K030614, K031632, K041402, K051189
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
Implant Innovations, Inc.
Implant Innovations, Inc.
510(k) Premarket Notification - A Modification to 3i OSSEOTITE® Dental Implants
Kos1461
510(k) 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. 561-514-6316 | |
| Email jhughes@3implant.com | |
| Date Prepared | May 25, 2005 |
| Device Name | 3i Nano CaP OSSEOTITE® Implants |
| Classification Name | Endosseous Dental Implant |
| Device | |
| Classification | Class II |
| 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 | |
| K955428 - Hydroxylapatite (HA) Coated Endosseous | |
| Implants | |
| K031475 - 3i OSSEOTITE NT Certain Implants | |
| K030614 - 3i Implants | |
| K031632 - 3i IOL Implants | |
| K041402 - OSSEOTITE NT Certain Implants | |
| K051189 - Prevail Implants |
1
ﮯ ﻟﯿﮯ
The 3i Nano CaP OSSEOTITE Dental Implants are Device Description provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nano-crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled /straight designs, and each design provides offerings for either external hex or internal connections. The 3i Nano CaP OSSEOTITE Dental Implants are Indications for Use indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abuiment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated. Substantial equivalence of the 31 Nano CaP OSSEOTITE Technological Dental Implants is based on: Characteristics 1. Design features and functions which are similar to the currently available OSSEOTITE, OSSEOTITE NT. OSSEOTITE Certain, OSSEOTITE Certain NT, and Prevail Implants and 31 Innovative Implants and Cover Screws. The OSSEOTITE surface is enhanced by the presence of nano-crystals of calcium phosphate which is similar to the Hydroxylapatite available -(HA) Coated currently Endosseous Dental Implants. 2. Performance testing. The proposed and currently marketed devices are identical in terms of size, biocompatible materials of construction, performance characteristics, and basic design. Laboratory testing was conducted to determine device Performance Testing functionality and conformance to to design indut requirements, as well as FDA's Class II Special Controls
2
Implant Innovations, Inc. Implant Innovations, Inc.
510(k) Premarket Notification - A Modification to 3i OSSEOTITE® Dental Implants
しく
Root-form Endosseous Dental Document: Guidance Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971.
The Ji Nano CaP OSSEOTITE Dental Implants are Conclusion Ine of Nano equivalent to the above mentioned legally marketed predicate devices, which provide the same or marketed precious, as well as technological characteristics. similar renetions, as and intended use are identical.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.
Public Health Service
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs and Quality Assurance Implant Innovations, Inc. 4555 Riverside Dr. Palm Beach Gardens, Florida 33410
Re: K051461
Trade/Device Name: 31 Osseotite Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 11, 2005 Received: August 12, 2005
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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must or any I edefal statutes and registments, 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. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter will and h your he FDA finding of substantial equivalence of your device to a legally prematics notification." The stassification 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 If you desire specific as 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 other golloral informational 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 for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page I of 1
510(k) Number (if known): _K051461
Device Name: 3i 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, ≥ 10 mm in length, arc placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Runsei
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number:
(Optional Format 3-10-98)