ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM

K052951 · Innova Life Sciences Corp. · DZE · Jan 27, 2006 · Dental

Device Facts

Record IDK052951
Device NameENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
ApplicantInnova Life Sciences Corp.
Product CodeDZE · Dental
Decision DateJan 27, 2006
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and 4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla. The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.

Device Story

Endosseous dental implant system; serves as artificial root to support dental prostheses. Implant features concentric steps along body; customized configurations for specific jaw regions (anterior mandible, anterior maxilla, posterior mandible, posterior maxilla). Surgical placement performed by dental professionals; requires preoperative assessment of buccolingual width and crestal bone height to ensure adequate alveolar bone volume. Device provides structural support for prosthetic restoration; benefits patient by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Endosseous dental implant; titanium-based (implied by class). Features concentric steps along body. Diameters: 3.75 mm, 4.5 mm, 5.0 mm. Lengths: 8.5 mm, 10 mm, 12 mm, 15 mm. Mechanical fixation via surgical placement into alveolar bone.

Indications for Use

Indicated for patients with edentulous or partially edentulous mandible or maxilla requiring artificial root components to support a prosthesis. Requires adequate alveolar bone volume; contraindicated if bone volume is insufficient for selected implant dimensions.

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}------------------------------------------------ K052951/ ## 510(K) SUMMARY FOR THE INNOVA LIFESCIENCES CORPORATION ENDOPORE® ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM ## Submitter's Name, Address, Telephone Number, and Contact Person Innova LifeSciences Corporation 60 Ironside Drive, Unit 3 Scarborough, Ontario M1X 1G4 Canada Contact: Michael A. Kehoe, President (416) 340-8818 Telephone: Facsimile: (416) 340-0415 #### Date Prepared October 18, 2005 ## Name of the Device Endopore® Anatomic Endosseous Dental Implant System #### Common or Usual Name Endosseous Implant and Abutment #### Classification Name Endosseous Implant (DZE); Endosseous Dental Implant Abutment #### (NHA) ## Predicate Devices Scalloped Endopore® Endosseous Dental Implant System (K043190); and Endopore® Endosseous Dental Implant System in lengths of 7, 9, or 12 mm with diameter of 4.1 mm (K926354); lengths of 7, 9, or 12 mm with diameter of 5 mm (K971196); and length of 5 mm length with diameter of 5 mm (032140). ### Intended Use ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. {1}------------------------------------------------ K052951 page 2 ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and 4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla. The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement. ## Principles of Operation The principles of operation of the modified device are identical to those of the previously cleared Scalloped Endopore® Endosseous Dental Implant System (K043190). ## Technological Characteristics The technological characteristics of the modified Endopore® Anatomic Endosseous Dental Implant System also are identical to those of the predicates, except for the use of customized configurations to fit specific anatomic jaw locations, including the anterior mandible, anterior maxilla, posterior mandible and posterior maxilla, and the addition of concentric "steps" along the length of the implant's body. The dimensions of the Anatomic Implant System include diameters of 3.75 mm, 4.5 mm, and 5 mm and lengths of 8.5 mm, 10 mm, 12 mm, and 15 mm. These dimensions are within the range of those of the previously cleared Endopore® Endosseous Dental Implant System, with the addition of the 3.75 mm diameter and 15 mm length. {2}------------------------------------------------ K052951 page 3 # Summary Basis for the Finding of Substantial Equivalence The minor modification to the design of the Scalloped Endopore® Endosseous Dental Implant System and Endopore® Endosseous Dental Implant System does not alter the implant's indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicate devices. - - - {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of three human profiles, stacked on top of each other. The profiles are depicted in a simple, abstract manner. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 7 2006 Innova Life Science Corporation C/O Mr. Howard M. Holstein Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Re: K052951 Trade/Device Name: Endopore® Anatomic Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZF, NHA Dated: November 28, 2005 Received: November 28, 2005 Dear Mr. Holstein: 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 vour 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 - Mr. Holstein 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, 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): K052951/ Device Name: Endopore® Anatomic Endosseous Dental Implant System Indications for Use: ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and 4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla. The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement. Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susa Re Page 1 of 1 Conersi Huspiel, Jon Control Dental Devices
Innolitics
510(k) Summary
Decision Summary
Classification Order
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