3I OSSEOTITE DENTAL IMPLANTS

K051461 · Implant Innovations, Inc. · DZE · Sep 15, 2005 · Dental

Device Facts

Record IDK051461
Device Name3I OSSEOTITE DENTAL IMPLANTS
ApplicantImplant Innovations, Inc.
Product CodeDZE · Dental
Decision DateSep 15, 2005
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended 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, are placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

Device Story

3i Nano CaP OSSEOTITE Dental Implants are root-form endosseous dental implants; feature proprietary acid-etched surface treated with nano-crystals of calcium phosphate. Available in tapered or parallel-walled designs with external hex or internal connections. Surgically placed in upper or lower jaw by dental professionals to support prosthetic attachments, including single crowns, fixed/removable bridges, and overdentures. Nano-crystal surface modification enhances osseointegration, similar to existing HA-coated implants. Device provides stable foundation for dental prosthetics; enables immediate loading protocols under specific clinical conditions (≥4 implants, ≥10mm length, anterior splinting).

Clinical Evidence

Bench testing only. Performance testing confirmed device functionality and conformance to design requirements and FDA Class II Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Technological Characteristics

Root-form endosseous dental implant; acid-etched surface with nano-crystals of calcium phosphate. Materials are biocompatible; design includes tapered or parallel-walled geometries with external hex or internal connections. Complies with FDA Class II Special Controls for dental implants. Risk management per ISO 14971.

Indications for Use

Indicated for patients requiring dental restoration in the upper or lower jaw. Applicable for single tooth restoration, partially or fully edentulous spans, fixed or removable bridgework, and overdenture retention. Immediate loading indicated when ≥4 implants (≥10 mm length) are placed in the maxilla/mandible and splinted in the anterior region.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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<br>Palm Beach Gardens, FL 33410 | | Contact | Jacquelyn A. Hughes, RAC<br>Director, Regulatory Affairs and Quality Assurance<br>Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. 561-776-6819<br>Fax. 561-514-6316<br>Email jhughes@3implant.com | | Date Prepared | May 25, 2005 | | Device Name | 3i Nano CaP OSSEOTITE® Implants | | Classification Name | Endosseous Dental Implant | | Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3640 | | Predicate<br>Devices | K014235 - OSSEOTITE NT™ Dental Implants<br>K972444 - <i>3i</i> Innovative Implants and Cover Screws<br>K935544 - Threaded Self-Tapping Threaded Implants<br>K980549 -- OSSEOTITE Dental Implants<br>K983347 - OSSEOTITE Dental Implants<br>K022009 - <i>3i</i> Dental Implants<br>K955428 - Hydroxylapatite (HA) Coated Endosseous<br>Implants<br>K031475 - <i>3i</i> OSSEOTITE NT Certain Implants<br>K030614 - <i>3i</i> Implants<br>K031632 - <i>3i</i> IOL Implants<br>K041402 - OSSEOTITE NT Certain Implants<br>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)
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%