The DIO Protem Implant Systems are 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.

Device Description

DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants 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 superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "DIO Protem Implant System (2.0/2.5mm)". This submission is for a medical device (endosseous dental implant system) and not for an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) and associated studies (MRMC, standalone, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods) is not applicable here.

Instead, the "acceptance criteria" for a medical device like this in a 510(k) submission typically revolves around demonstrating substantial equivalence to a previously legally marketed predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to performance testing (bench testing) and a thorough comparison against the predicate device to show that the new device is as safe and effective.

Here's how to interpret the information provided in the context of a traditional medical device 510(k) submission:

Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The "acceptance criteria" for the DIO Protem Implant System (2.0/2.5mm) is demonstrating substantial equivalence (SE) to its predicate device, the DIO Protem Implant System (K06710568). This is the primary criterion for clearance under a 510(k).

The "study" or evidence provided to prove the device meets this acceptance criterion is a substantive comparison of its technological characteristics and intended use to the predicate device, supported by laboratory testing.

1. Table of Acceptance Criteria and the Reported Device Performance (interpreted for medical devices, not AI):

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance / Characteristics (Subject Device)	Predicate Device (K06710568)
Intended Use: Identical to the predicate device's intended use.	Identical to predicate devices	The DIO Protem Implant Systems are 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: Same material as the predicate device.	Titanium alloy	Titanium alloy
Screw Threads: Presence of screw threads as in the predicate.	YES	YES
Implant Thread Diameter: Within the range of the predicate device.	2.0 and 2.5 mm	2.0 and 2.5 mm
Lengths: Within the range of the predicate device.	8-14 mm	8-14 mm
Surface Treatment: Same type of surface treatment as the predicate device.	Sanded (also mentions sandblasted, RBM treated)	Sanded
Sterilization: Sterilized in the same manner as the predicate.	YES (gamma sterilized for implants)	YES
Functionality & Conformance to Design Input Requirements: Demonstrated through laboratory testing.	Laboratory testing was conducted to determine device functionality and conformance to design input requirements.	(Implied to meet similar standards as predicate)
Components: Similar overall system components (implants, superstructure, prosthetics, surgical instruments).	Protem Implants, Superstructure, Prosthetics, Surgical Instruments.	(Implied similar, as it's the same system, with information being changed. The 510(k) summary is for changing some information of the prior submission, not for a brand new system).

2. Sample size used for the test set and the data provenance:

Not applicable for this type of medical device submission. The evaluation relies on the physical and material characteristics of the device, as well as bench testing to verify performance, rather than a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for AI/ML device performance is not relevant here.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established by engineering specifications, material science standards, and performance test results. For instance, the stated dimensions (e.g., diameter, length) are verified directly against engineering drawings and manufacturing tolerances.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm being "trained."

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

Not applicable.

Summary

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K080126

Attachment 4.

APR 1 1 2008

510(k) Summary

DIO Protem Implant System

1. Submitter	DIO Department, DSI, Inc.117 Kyo-Dong, Yangsan-CityKyungnam-Do, 626-210, KoreaPhone: 82-55-383-7900Fax : 82-55-363-3404
2. US Agent /Contact Person	Hyungick Kim3540 Wilshire Blvd. #1104 Los Angeles,CA 90010, USAPhone : 213-365-2875, Fax : 213-365-1595
3. Date Prepared	January 08, 2008
4. Device Name	DIO PROTEM IMPLANT SYSTEM (2.0/2.5MM)
5. Classification Name	Endosseous Dental Implant System
6. Device Classification	Class IIDental Devices panelRegulation Number: 21 CFR 872.3640
7. Predicate Devices	DIO Protem Implant System(510(k) No: K06710568)
8. Performance	Laboratory testing was conducted to determine device functionality andconformance to design input requirements.
9. Purpose	The purpose of this 510(k) is to change the some information of prior510(k) submission for the DIO Protem Implant System.

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10. Device Description

DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments.

The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants 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 superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture.

The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.

The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.

11. Packing / Labeling / Product Information

DIO Protem Implant System(2.0/2.5mm) follows the guidance of the 21 CFR 872.3640.

12. Intended Use

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13. Substantial Equivalence Comparison

	Subject Device	Predicate Device
Device Name	DIO Department, DSI, Inc.(DIO Protem Implant System(2.0/2.5mm))	DIO Department, DSI, Inc.(DIO Protem Implant System)K070568
Intended Use	Identical to predicate devices	The DIO Protem Implant Systems are 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	Titanium alloy	Titanium alloy
Screw Threads	YES	YES
Implant ThreadDiameter (mm)	2.0 and 2.5	2.0 and 2.5
Lengths(mm)	8-14 mm	8-14 mm
Surface Treatment	Sanded	Sanded
Sterilized	YES	YES

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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APR 1 1 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: K080126

Trade/Device Name: DIO Protem Implant System (2.0/2.5mm) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 27, 2008 Received: April 3, 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.

Judite Y. Michael Davis.

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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Attachment 2.

Indication for Use

4080126

510(K) Number (if known): _

Device Name: DIO Protem Implant System.(2.0/2.5mm)

Indications For Use:

Kei Maly for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080126.

Over - The-Counter Use AND/OR Prescription Use (Per 21 CFR 801.109) (Part 21 CFR 801 Subpart D)

(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.