(224 days)
Not Found
No
The summary describes a standard dental implant system and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is an endosseous dental implant system, directly providing a therapeutic effect by replacing missing teeth and restoring chewing function.
No
Explanation: The device is an implant system used for restoring chewing function and supporting dental restorations, not for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of dental implants, superstructures, and instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The provided text describes a dental implant system that is surgically placed inside the body (in vivo) to restore chewing function. It is a physical implant and associated instruments for surgery and prosthetics.
- Intended Use: The intended use is for surgical placement in the jaw to support prosthetic appliances. This is a surgical and restorative procedure, not a diagnostic test performed on a sample.
The description clearly indicates a device used for surgical implantation and restoration within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments.
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches, anterior 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 input requirements.
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.
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
Special 510(k): Device Modification
DIO SM Implant System
OCT 0 9 2008
Attachment 4.
510(k) Summary
DIO SM Implant System
- Submitter
DIO Department, DSI, Inc. 117 Kyo-Dong, Yangsan-City Kyungnam-Do, 626-210, Korea Phone: 82-55-383-7900 Fax : 82-55-363-3404
-
- US Agent / Contact Person
CONTACT REPORT
- US Agent / Contact Person
-
Date Prepared
-
Device Name
-
Classification Name
-
Device Classification
-
Predicate Devices
-
Performance
-
Purpose
Hyungick Kim 3540 Wilshire Blvd. #1104 Los Angeles, CA 90010, USA Phone : 213-365-2875, Fax : 213-365-1595
January 08, 2008
DIO SM IMPLANT SYSTEM
Endosseous Dental Implant System
Class II Dental Devices panel Regulation Number: 21 CFR 872.3640
SM Implant System(510(k) No: K061797)
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
The purpose of this 510(k) is to modify the prior 510(k) submission for the SM Implant System
1
Charles of the Research Children of the Children Children of the Children
10. Device Description
The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments.
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
11. Packing / Labeling / Product Information
DIO SM Implant System follows the guidance of the 21 CFR 872.3640..
12. Intended Use
The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
13. Substantial Equivalence Comparison
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | ||
| Name | DIO Department, DSI, Inc. | DIO Department, DSI, Inc. |
| Device Name | DIO SM Implant System | SM Implant System |
| 510(k) Number | Not available yet | K061797 |
| Subject Device | Predicate Device | |
| Intended Use | Same with predicate device | The DIO SM Implant System is an |
| endosseous dental implant is indicated for | ||
| surgical placement in the upper and lower | ||
| jaw arches, to provide a root form means | ||
| for single or multiple units' prosthetic | ||
| appliance attachment to restore a patient's | ||
| chewing function. Implants can be placed | ||
| with a conventional two stage surgical | ||
| process with an option for transmucosal | ||
| healing or they can be placed in a single | ||
| stage surgical process for immediate | ||
| loading. Immediate loading is restricted to | ||
| the anterior mandible, based on four | ||
| interforminal placed implants, and not | ||
| indicated for single unsplinted implants. | ||
| Patients must be subject for dental | ||
| treatment with endosseous implants. | ||
| Material | CP Ti Gr4 | CP Ti Gr4 |
| Design | Internal Type and Morse Tapered | Internal Type and Morse Tapered |
| Screw Threads | YES | YES |
| Implant | ||
| Diameters(mm) | 3.8/4.5/5.3 | 4.1/4.5/5.0/5.3 |
| Implant | ||
| Lengths(mm) | 7/8.5/10 | 7.0-12.5 |
| Surface | ||
| Treatment | RBM (Resorbable Blast Media) | RBM (Resorbable Blast Media) |
| Sterilization | ||
| Method | GAMMA | GAMMA |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |
TECHNOLOGICAL CHARACTERISTIC COMPARISON
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Special 510(k): Device Modification __________________________________________________________________________________________________________________________________________
. .
____DIO SM Implant System
. . .
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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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
OCT 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DIO Department, DSI, Incorporated C/O Mr. Hyungick Kim Manager DIO, USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010
Re: K080559
Trade/Device Name: DIO SM Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 19, 2008 Received: September 30, 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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely vours.
$\mathbb{V}$Ammelts-Lussards for $\eta$
Chiu S. Lin, Ph. D Division 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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Attachment 2.
Indication for Use
510(K) Number (if known): K080559
Device Name: DIO SM Implant System
Indications For Use:
The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
ts.
Suertunya
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080559
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)