(79 days)
K-003226, K011879, K-002188
K-003226, K011879, K-002188
No
The summary describes a standard dental implant system and its components, with no mention of AI or ML capabilities. The performance studies focus on biocompatibility, durability, and surface characteristics, not algorithmic performance.
Yes.
This device is designed to be surgically implanted to achieve firm and direct connection between living bone and the surface of a titanium fixture, in support of single or multiple-unit restorations. These functions are therapeutic as they treat partially or fully edentulous mandibles and maxillae.
No.
The AVANA Dental Implant Systems are designed for use in dental implant surgery as a replacement for teeth, not to diagnose a condition.
No
The device description explicitly details physical components like implants, abutments, and surgical accessories (drills, drivers, etc.), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental implant surgery" and is used to "support of single or multiple-unit restorations." This describes a surgical procedure and a device implanted within the body.
- Device Description: The description details a "threaded, root form endosseous implant" made of titanium, along with surgical and restorative components. This is a physical implant and associated tools for a surgical procedure.
- 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 samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is surgically implanted within the body.
N/A
Intended Use / Indications for Use
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Product codes
DZE
Device Description
The Avana SS-II Implant is a threaded, root form endosseous implant comprised of an internal octa, one-stage 8° morse tapered device manufactured from commercially pure titanium. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw-on and cemented abutments, healing abutments, and angled abutments. Surgical accessories include drills, depth gages, drivers, torque wrenches, taps, reamers and fixture mount removal tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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)
Biocompatibility of the AVANA Dental Implant System was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Animal studies were conducted to determine the performance of the surface treatment. In-vitro performance tests were conducted to establish device durability as well as to characterize the implant surface treatment and purity. These studies included compression and fatigue tests as well as spectroscopic studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-003226, K011879, K-002188
Reference Device(s)
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
SEP - 1 2005
510(k) Summary
Prepared May 24, 2005
| TRADE NAME | AVANA Dental Implant System |
|---|---|
| GENERIC NAME | Endosseous Implant |
| CLASSIFICATION | Class II (21 CFR 872.3640) |
| SUBMITTED BY | EK SCIENCE REASEARCH INTL. CO. |
| 9494 Silver Fern Pl. | |
| Rancho Cucamonga, CA 91730 | |
| tel. (909) 980-9933 | |
| fax. (909) 980-9951 | |
| email - ekscience@usa.com | |
| for | |
| Osstem Co., Ltd. | |
| #38-44, Guje 3-Dong | |
| Busan | |
| Republic of Korea | |
| 612-073 | |
| CONTACT | Mr. Ki Won Kim |
| PREDICATE | |
| DEVICE | Lifecore Stage -1 Single Stage RBM Dental Implant System, K- |
| 003226 | |
| Osstem Co. 3A Dental Implant System, K011879 | |
| Swissplus Dental Implant, K-002188 | |
| DEVICE | |
| DESCRIPTION | The Avana SS-II Implant is a threaded, root form endosseous |
| implant comprised of an internal octa, one-stage 8° morse tapered | |
| device manufactured from commercially pure titanium. The | |
| implant's external threaded surfaces are roughened to facilitate | |
| tissue and bone integration. The implant's self-tapping feature may | |
| be used with or without pre-tapping the bone. System components | |
| for restorative purposes include: screw-on and cemented | |
| abutments, healing abutments, and angled abutments. Surgical | |
| accessories include drills, depth gages, drivers, torque wrenches, | |
| taps, reamers and fixture mount removal tool. |
1
osstem co., LTD. TRADITIONAL 510(K): AVANA DENTAL IMPLANT SYSTEM
K05/576
| INDICATIONS
| FOR USE | AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. |
|---|---|
| TESTING | Biocompatibility of the AVANA Dental Implant System was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Animal studies were conducted to determine the performance of the surface treatment. |
| In-vitro performance tests were conducted to establish device durability as well as to characterize the implant surface treatment and purity. These studies included compression and fatigue tests as well as spectroscopic studies. | |
| SUMMARY OF | |
| SUBSTANTIAL | |
| EQUIVALENCE | The AVANA Dental Implant System is substantially equivalent to the predicate devices in its construction, intended use and principles of operation. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2005
Osstem Company Limited C/O Albert Rego, Ph.D. 27001 La Paz, Suite 312 Mission Viejo, California 92691
Re: K051576
Trade/Device Name: AVANA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 10, 2005 Received: June 14, 2005
Dear Dr. Rego:
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 - Dr. Rego
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,
Singite Y. Michael Omd
Chiú 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
4
OSSTEM CO., LTD. TRADITIONAL 510(K): AVANA DENTAL IMPLANT SYSTEM
Indications for Use Statement
510(k) Number (if known): _ KO 5/ 5760
Device Name:
AVANA Dental Implant System
Indications for Use:
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Suza Qumara
Over the Counter Use
(Division Sign-Off) (Division Sign-Olf)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051576