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.

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.

AI/ML Overview

This submission, K080128, for the SM-Extra Wide(RBM) Implant System, does not describe an AI/ML powered device. Instead, it is a traditional 510(k) submission for a dental implant system. As such, the information you've requested regarding acceptance criteria and studies proving the device meets those criteria, particularly with reference to AI/ML specific performance metrics, is not present in the provided text.

The submission focuses on establishing substantial equivalence to a predicate device (Rescue Internal Dental Implant System, K063216) based on technological characteristics and intended use.

Here's an analysis of the provided text in relation to your questions, highlighting why most AI/ML-specific questions are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies acceptance criteria are based on device functionality and conformance to design input requirements, as stated in section 8: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, specific numerical acceptance criteria (e.g., success rates, torque values, fatigue limits) for these "design input requirements" are not explicitly listed in the provided text.
Reported Device Performance: The primary "performance" reported is the demonstration of substantial equivalence to the predicate device. This is shown through a direct comparison of technological characteristics in Section 12. No quantitative performance data from clinical trials or specific laboratory tests (beyond the general statement above) are provided or summarized.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Function as intended to provide prosthetic support.	Same as predicate device.
Material	Biocompatible and strong (CP Ti Gr4).	CP Ti Gr4 (Same as predicate).
Design	Internal Type and Morse Tapered for stable connection.	Internal Type and Morse Tapered (Same as predicate).
Screw Threads	Presence for secure fixation.	YES (Same as predicate).
Implant Diameters	Within a range suitable for dental implant applications.	5.9/6.4/6.9 mm (Comparable to predicate 6.0/6.5/7.0/8.0).
Implant Lengths	Within a range suitable for dental implant applications.	7/8.5/10 mm (Comparable to predicate 7.0-12.5).
Surface Treatment	Promotes osseointegration (RBM).	RBM (Resorbable Blast Media) (Same as predicate).
Sterilization Method	Effective sterilization for patient safety (GAMMA).	GAMMA (Same as predicate).
Attachments	Compatibility with various abutments and components.	Various abutments and components (Same as predicate).
Product Code	Aligned with regulatory classification (DZE).	DZE (Same as predicate).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a physical medical device (dental implant) and not an AI/ML algorithm or software that operates on data. The "testing" mentioned is laboratory testing of the physical implant's functionality, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, in the context of expert consensus, is relevant for evaluating the performance of diagnostic or prognostic AI/ML models. For a physical dental implant, "ground truth" would be established through established engineering and biocompatibility standards, not expert adjudication of a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used in studies involving human interpretation or consensus for data labeling/ground truth in AI/ML performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are specific to evaluating diagnostic systems, particularly imaging devices or AI tools, and their impact on human reader performance. This submission is for a physical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This refers to the standalone performance of an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance of this physical implant, the "ground truth" implicitly relies on engineering standards, material science properties, biocompatibility testing (which may involve in-vitro or animal studies, though not detailed here), and successful historical clinical use of physically similar predicate devices. No explicit "ground truth" of the types listed (expert consensus, pathology, outcomes data) for a data-driven evaluation is mentioned.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm being "trained" in this submission.

9. How the ground truth for the training set was established

This is not applicable. There is no AI/ML algorithm being "trained" in this submission.

In summary, the K080128 submission is a standard 510(k) for a physical medical device, demonstrating substantial equivalence to a predicate. The questions posed are primarily relevant to AI/ML powered devices, which this product is not.

Summary

{0}------------------------------------------------

Traditional 510(k) Submission

K080128

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.

{1}------------------------------------------------

K080128

20/3

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.

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

{2}------------------------------------------------

12. Substantial Equivalence Comparison

TECHNOLOGICAL CHARACTERISTIC COMPARISON

	Subject Device	Predicate Device
ManufacturerName	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 isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose of providing prostheticsupport for dental restoration (Crown,Bridges, and overdentures) in partiallyor fully edentulous individuals. TheseFixtures can be used where smallerimplants have failed.
Material	CP Ti Gr4	CP Ti Gr4
Design	Internal Type and Morse Tapered	Internal Type and Morse Tapered
Screw Threads	YES	YES
ImplantDiameters(mm)	5.9/6.4/6.9	6.0/6.5/7.0/8.0
ImplantLengths(mm)	7/8.5/10	7.0-12.5
SurfaceTreatment	RBM (Resorbable Blast Media)	RBM (Resorbable Blast Media)
SterilizationMethod	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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

K080128

Indication for Use

510(K) Number (if known):

Device Name: SM-Extra Wide(RBM) Implant System

Indications For Use:

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)

Page 1 of 1

Regulation Number and Section

§ 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.