(134 days)
Not Found
No
The summary describes a physical dental implant and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device, a dental implant, is designed to replace missing teeth and provide stability for dental prostheses. While it contributes to restoring oral function and aesthetics, its primary role is structural and restorative rather than directly treating a disease or therapeutic condition in the medical sense.
No
The device, "Secure Implant System(2.5/3.0mm)", is a dental implant system designed for use in dental implant surgery to integrate with bone. Its intended use is for fixation of crowns, bridges, and dentures. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states it is a root-form threaded dental implant made of titanium alloy, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a dental implant. It is a physical device surgically placed into the bone to support dental prosthetics. It is used in the body, not to test specimens from the body.
The provided information clearly describes a medical device used in a surgical procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
Product codes
DZE
Device Description
Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 input requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Traditional 510(k) Submission
Secure Implant System(2.5/3.0mm)
MAY 3 0 2008
510(K) SUMMARY Secure Implant System (2.5/3.0mm)
14-1. Submitter DSI Jin Choel, Kim(President) Eun Jin, Kim(Regulatory affair staff) 117 Kyo-Dong, Yangsan-City Kyungnam-Do, 626-210, Korea Phone: 82-55-383-7900 Fax : 82-55-363-3404 Hyungick Kim/ Timothy Lee 14-2. US Agent / 3540 Wilshire Blvd. #1104 Los Angeles, Contact Person CA 90010, USA Phone : 213-365-2875, Fax : 213-365-1595 January 08, 2008 14-3. Date Prepared SECURE IMPLANT SYSTEM(2.5/3.0MM) 14-4. Device Name Endosseous Dental Implant System 14-5. Classification Name Class II 14-6. Device Classification Dental Devices panel Regulation Number: 21 CFR & 872.3640 INTERMEZZO TM Plus(510(k) No.: K053354) 14-7. Predicate Devices Zimmer One-Piece Implant System (510(k) No .: K052997) Laboratory testing was conducted to determine device functionality 14-8. Performance and conformance to design input requirements.
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14-9. Device Description
Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.
14-10. Packing / Labeling / Product Information
In a clean room that is Class 10,000 or less, put the product into a plastic ampoule, and then put the plastic ampoule in a pet container, then sealed the pet container with Tyvek®. Secure Implant System(2.5/3.0mm) will be packaged.
14-11. Intended Use
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
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14-12. Substantial Equivalence Comparison
| Subject Device | Predicate Device II | |
|---|---|---|
| Manufacturer | ||
| Name | DSI | Mega'Gen Co., Ltd. |
| Device Name | Secure Implant System (2.5/3.0mm) | IntermezzoTM Plus (K053354) |
| Intended Use | Secure Implant System(2.5/3.0mm) is | |
| designed for use in dental implant surgery | ||
| and is intended for use in a manner in | ||
| which the implants integrate with the | ||
| bone(osseointegration). It is intended to | ||
| provide immediate transitional splinting | ||
| stability or intrabony long-term fixation of | ||
| new or existing crown, bridge and denture | ||
| installations in partially or fully | ||
| edentulous patients | IntermezzoTM Plus are gned for use in dental implant surgery and are | |
| intended to be used in a manner in | ||
| which the implants integrate with the | ||
| bone (osseointegration). The system is | ||
| intended for use in partially or fully | ||
| edentulous mandibles and maxillae, in | ||
| support of overdentures. | ||
| Material | Titanium Alloy | CP-Ti Gr3 |
| Screw Threads | YES | YES |
| Implant Thread | ||
| Diameter(mm) | 2.5/3.0 | 2.5-3.1 |
| Lengths(mm) | 8.0-16.0 | 10.0-15.0 |
| Surface | ||
| Treatment | Yes | No |
| Sterilized | GAMMA | GAMMA |
TECHNOLOGICAL CHARACTERISTIC COMPARISON
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle emblem. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 8 0 2008
DIO Department, DSI, Incorporated C/O Mr. Hyungick Kim Manager DIO, USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010
Re: K080129
Trade/Device Name; Secure Implant System (2.5/3.0mm) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 8, 2008 Received: May 12, 2008
Dear Mr. Kim:
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.
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Page 2 – Mr. Kim
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 (OS) 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 Liu, Ph.D.
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
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Secure Implant System(2.5/3.0mm)
Indication for Use
510(K) Number (if known):
Device Name: Secure Implant System (2.5/3.0mm)
Indications For Use:
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
Susa Cuomo
(Division Sign-Off) Division of Anesthesiblogy, General Hospital Infection Control, Dental Devices
510(k) Number: K060129
Prescription Use AND/OR Over -- The-Counter Use (Part 21 CFR 801 Subpart D) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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