(30 days)
No
The device description focuses on the materials, dimensions, and mechanical function of dental implants and associated instruments. There is no mention of AI, ML, image processing, or data analysis capabilities.
No.
This device provides temporary support for prosthetic devices during healing and is not intended to treat or cure a medical condition.
No
Explanation: The device is an implant system used for temporary support of prosthetic devices during healing, not for diagnosing a condition or disease. It is a treatment device.
No
The device description explicitly lists hardware components such as Dental Implants, Superstructure, and Instruments made of Titanium Alloy.
Based on the provided information, the DioSlimon Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- DioSlimon Implant System Function: The description clearly states that the DioSlimon Implant System is an implantable device used to provide temporary support for provisional dental prosthetics during the healing phase of permanent implants. It is surgically placed within the mandibles and maxillae.
- Lack of Diagnostic Purpose: The intended use and device description do not mention any diagnostic function or the analysis of biological specimens.
Therefore, the DioSlimon Implant System falls under the category of a medical device (specifically, a dental implant system), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DioSlimon Implant System is intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Product codes
DZE
Device Description
DioSlimon Implant System consists of Dental Implants, Superstructure, Instruments of Prosthetic and Surgical Instruments. The Dental Implant of the DioSlimon Implant System is an integrated system of endosseous dental implant which designed to protect main implant from immediate loading during osteointegration period; to increase indurance of temporary tooth and to the immediate functions and immediate recovery of aesthetics of conduct osteoimplanted area. These are made of Titanium Alloy(Ti-6AI-4V ELI / ASTM F136) which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructure consists of Ball Cap intended to retain the O-ring inside of the denture. The Instruments of Prosthetic and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Dental Implant is gamma sterilized and intended to single use. And the others are non-gamma sterilized. It have to be sterilized by user before using.
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)
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)
DIO Protem Implant System(2.0/2.5mm) (K080126)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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)
OCT 2 1 2011
DioSlimon Implant System(2.0/2.5mm)
Attachment 4
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
| 1. Submitter | DIO Corporation
1464 U-dong, Haeundae-gu, Busan, 612-020, Korea
Tel.: 82-51-745-7777
Fax.: 82-51-745-7779 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 2. US Agent /
Contact Person | DIO, USA. Tim. C.J. Lee
3540 Wilshire Blvd. #1104 Los Angeles, CA 90010, USA
Tel.: 213-365-2875
Fax.: 213-365-1595 |
| 3. Trade Name | DioSlimon Implant System |
| 4. Common Name | Dental Implant |
| 5. Classification Name | Endosseous Dental Implant
21 CFR 872.3640
Class II DZE |
| 6. Predicate Devices | DIO Protem Implant System(2.0/2.5mm) (K080126) |
7. Device Description
DioSlimon Implant System consists of Dental Implants, Superstructure, Instruments of Prosthetic and Surgical Instruments.
and & J. 1. 2 ﺔ ﻣﻦ ﻣﻦ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
The Dental Implant of the DioSlimon Implant System is an integrated system of endosseous dental implant which designed to protect main implant from immediate loading during osteointegration period; to increase indurance of temporary tooth and to
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Company Comments
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
. 19
1
the immediate functions and immediate recovery of aesthetics of conduct osteoimplanted area. These are made of Titanium Alloy(Ti-6AI-4V ELI / ASTM F136) which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm).
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
собсавания соберавности се седнительно приведения по полития
The superstructure consists of Ball Cap intended to retain the O-ring inside of the denture.
i
The Instruments of Prosthetic and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The Dental Implant is gamma sterilized and intended to single use. And the others are non-gamma sterilized. It have to be sterilized by user before using.
、日本のお、まずはアッキングに行っていたのか、インタ 8. Intended Use
The DioSlimon Implant System is intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
9. Performance
、
の - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
10. Packing / Labeling / Product Information
DioSlimon Implant System follows the guidance of the 21 CFR872.3640.
11. Substantial Equivalence Comparison Jul Comparison
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| ・・ | - » - » - » : « : « » : « » : « | as and submit of the seen and the many of the security of | ||
| : 39/4/14/2017 : 39/41/10/08/11/1 | ||||
| history. Halls = E gostigation = Espansary = por = = = = = = = = = = = = = = = = = = = = |
2
Special_510(k)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
: . . . . . . . . . . . . .
| Manufacturer
| Name | DIO Corporation | DIO Department, DSI, Inc. |
|---|---|---|
| Device Name | DioSlimon Implant System | DIO Protem Implant System(2.0/2.5mm) |
| (K080126) | ||
| Intended Use | Same with predicate device | The DIO Protem Implant System |
| (2.0/2.5mm) is intended to load | ||
| immediately in partially or fully | ||
| edentulous mandibles and maxillae to | ||
| serve as temporary support for | ||
| provisional prosthetic device during the | ||
| healing phase of permanent | ||
| endosseous dental implants. | ||
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Screw Threads | YES | YES |
| Implant | ||
| Diameters(mm) | 2.0/2.5 | 2.0/2.5 |
| Implant | ||
| Lengths(mm) | 8/10/12/14 | 8/10/12/14 |
| Surface | ||
| Treatment | RBM (Resorbable Blast Media) | RBM (Resorbable Blast Media) |
| Sterilization | ||
| Method | Gamma | Gamma |
| Attachments | Various abutments and components | Various abutments and components |
This summary of 510(K) safety and effectiveness information is being submitted in . accordance with the requirements of 21 CFR & 807.93 : : and and the same of the same
12. Conclusion
:
:
- ... - .. The evaluation of the DioSlimon Implant System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
:
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100 mp 100
3
Image /page/3/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OET 2 1 2011
DIO Corporation C/O Mr. Timothy Lee Manager DIO USA 3540 Wilshire Road, Suite 1104 Los Angeles, California 90010
Re: K112746
Trade/Device Name: DioSlimon Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 1, 2011 Received: September 21, 2011
Dear Mr. Lee:
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. Please note; CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Lee
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Anton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) _______________________________________________________________________________________________________________________________________________________________
DioSlimon_Implant_System(2.0/2.5mm)
Attachment 2
Indications for Use Statement
and the first and the states 8 . . . . . . . . . . . . . 510(K) Number (if known) : ___________________________________________________________________________________________________________________________________________________
Device Name : DioSlimon Implant System
Indications For Use :
ーストート | アイストレス .. . . . . . . . . . . . . . . . . . . . . .
The DioSlimon Implant System is intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase fo permanent endosseous dental implants. .
トートーースが始まってきた、無料理、は100mmを取り
Prescription Use ___________________________________________________________________________________________________________________________________________________________ AND/OR _______________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
and the comments of the comments of the country of
・・・・・・・・
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 36/41 | |
| 510(k) Number: | 412346 |