(118 days)
Not Found
No
The 510(k) summary describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an implant fixture designed to provide prosthetic support for dental restoration, which is a structural or cosmetic function, not a therapeutic one that treats or prevents a disease.
No
The device description indicates that the implant fixture is surgically placed to provide prosthetic support for dental restoration, not to diagnose a condition.
No
The device description explicitly states it consists of physical components made of titanium (fixtures, abutments, prosthetics, surgical instruments), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be surgically placed in the jawbone to support dental restorations. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical implant system made of titanium, including fixtures, abutments, and instruments for placement and restoration. This aligns with a medical device for surgical implantation, not an IVD.
- No mention of biological samples: There is no mention of the device interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
Therefore, the SM-Extra Wide(RBM) Implant Fixture is a medical device for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments, prosthetics and surgical instruments.
SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed.
These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals.
The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandivular molar areas
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
Traditional 510(k) Submission
510(K) SUMMARY SM-Extra Wide(RBM) Implant System
MAY 1 4 2008
- 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
Hyungick, Kim 3540 Wilshire Blvd. #1104 Los Angeles, CA 90010, USA Phone : 213-365-2875, Fax : 213-365-1595
- Date Prepared
January 08, 2008
- Device Name
SM-EXTRA WIDE(RBM) IMPLANT SYSTEM
-
Classification Name
-
Device Classification
Class II Dental Devices panel Regulation Number: 21 CFR 872.3640
Endosseous Dental Implant System
- Predicate Devices
Rescue Internal Dental Implant System (510(k) No.: K063216)
- Performance
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
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MAY 1 4 2008
9. Device Description
SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments, prosthetics and surgical instruments.
SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed.
These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals.
The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.
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". SM-Extra Wide(RBM) Implant System will be packaged.
11. Intended Use
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.
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12. Substantial Equivalence Comparison
TECHNOLOGICAL CHARACTERISTIC COMPARISON
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | ||
| Name | DIO Department, DSI, Inc. | MegaGen Co.,Ltd. |
| Device Name | SM-Extra Wide(RBM) Implant System | Rescue Dental Internal Implant System |
| 510(k) Number | Not available yet | K063216 |
| Intended Use | Same with predicate device | The Rescue Internal Implant is |
| intended to be surgically placed in the | ||
| maxillary or mandibular molar areas | ||
| for the purpose of providing prosthetic | ||
| support for dental restoration (Crown, | ||
| Bridges, and overdentures) in partially | ||
| or fully edentulous individuals. These | ||
| Fixtures can be used where smaller | ||
| implants have failed. | ||
| 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) | 5.9/6.4/6.9 | 6.0/6.5/7.0/8.0 |
| 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 |
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 consists of a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
DIO Department, DSI, Incorporated C/O Mr. Hyungick Kim Manager DIO, USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010
Re: K080128
Trade/Device Name; SM-Extra Wide(RBM) Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 9, 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 (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.
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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Indication for Use
510(K) Number (if known):
Device Name: SM-Extra Wide(RBM) Implant System
Indications For Use:
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.
Saad Romer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080128
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over – The-Counter Use (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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