The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use 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. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.

Device Description

The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).

AI/ML Overview

Here's an analysis of the provided text regarding the DIO Biotite-H Implant Systems:

Acceptance Criteria and Study for DIO Biotite-H Implant Systems

The provided 510(k) summary for the DIO Biotite-H Implant Systems indicates that the device's performance was evaluated through laboratory testing to determine functionality and conformance to design input requirements. However, the document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., accuracy, sensitivity, specificity, or failure rates). Instead, the primary "acceptance criteria" appear to be focused on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.

The study presented is a substantial equivalence comparison rather than a traditional clinical or performance study with defined numerical acceptance criteria for device efficacy or safety. The document aims to show that the new device is as safe and effective as previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for performance are not provided. The "reported device performance" is essentially a statement of comparability to the predicate device in several key aspects.

Feature	Acceptance Criteria (Implied by Predicate - K955428)	Reported Device Performance (DIO Biotite-H Implant System)
Intended Use	The implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.	Identical to predicate devices
Material	Commercially pure titanium Gr. 3 and Gr.4 (ASTM-F-67)	Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)
Design	Morse Taper with Thread	Morse Taper with Thread
Screw Threads	YES	YES
Implant Thread Diameter (mm)	3.8, 4.5, and 5.3 mm	3.8, 4.1, 4.5, 4.8 and 5.3 mm
Collar Height (mm)	1.8	1.8
Lengths (External)	8-14 mm	8-14 mm
Surface Treatment	HA Coating	HA Coating (specifically 100% calcium phosphate (CaHPO42H2O), thin bioactive layer of a calcium phosphate composite, composed of brushite (>95%) and HA (<5%))
Sterilization	Gamma sterilized	Gamma sterilized
Functionality	Demonstrated through predicate device's history and design characteristics.	Laboratory testing to determine device functionality and conformance to design input requirements. No specific performance metrics or results are reported in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test set sample size: Not applicable in the context of this 510(k) summary. The "test set" for demonstrating substantial equivalence is the predicate device's existing performance data and regulatory history, along with the results of the manufacturer's internal laboratory testing. No specific number of implants or "test cases" for a human-in-the-loop or standalone study are mentioned.
Data provenance: The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" (Section 15-8). This implies internal testing by the manufacturer (DIO Department, DSI, Inc. in South Korea). The specific country of origin for the data generated from this testing is South Korea, as that is the submitter's location. The testing would be prospective in the sense that it was performed on the specific new device for this submission, but its purpose was to uphold the claim of equivalence to existing devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable to the provided 510(k) summary. The submission is for a medical device (dental implant), not an AI/software as a medical device (SaMD) that typically requires expert-established ground truth for performance studies. The "ground truth" for this device's safety and effectiveness is primarily established through its physical and material properties, design specifications, and comparison to existing, legally marketed predicate devices.

4. Adjudication Method for the Test Set

This question is not applicable as there is no mention of a traditional "test set" involving human interpretation or expert review for a clinical performance study. The evaluation method described is a comparison of technological characteristics and intended use to predicate devices, supported by internal laboratory testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The DIO Biotite-H Implant System is a physical dental implant, not an AI/SaMD.

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

No, a standalone performance study (in the context of AI algorithms) was not done. Again, this is a physical medical device. The "standalone performance" was evaluated through laboratory testing of the implant's physical properties and functionality. The document does not provide details of these tests, only that they were conducted.

7. The Type of Ground Truth Used

For the substantial equivalence comparison, the "ground truth" is the established regulatory clearance and safety/effectiveness profile of the predicate device (IMPLANT INOVATION, INC. (K 955428) and other listed predicates), as well as recognized industry standards (e.g., ASTM-F-67, ASTM-F-136) for material properties.
For the laboratory testing mentioned, the "ground truth" would be the predefined design input requirements and functional specifications for the implant, often derived from engineering standards and clinical expectations for dental implants.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for an AI model.

Summary

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

K073070

510(K) SUMMARY DIO Biotite-H Implant Systems

MAY 1 6 2008

	MAY 16 2008
15-1. Submitter	DIO Department, DSI, Inc.117 Kyo-Dong, Yangsan-CityKyungnam-Do, 626-210, South KoreaPhone: 82-55-363-3401Fax : 82-55-363-3404
15-2. US Agent /Contact Person	PhD. Steve Chang13340 E. Firestone Blvd. Suite JSanta Fe Springs, CA 90670Phone : 562-404-8466, Fax : 562-404-2757
15-3. Date Prepared	October 26, 2007
15-4. Device Name	DIO BIOTITE-H IMPLANT SYSTEMS
15-5. Classification Name	Endosseous Dental Implant System
15-6. Device Classification	Class IIDental Devices panel21 CFR § 872.3640Regulation Number:
15-7. Predicate Devices	IMPLANT INOVATION, INC. (K 955428)
15-8. Performance	Laboratory testing was conducted to determine device functionalityand conformance to design input requirements.

1. 1

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

15-9. Device Description

15-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. DIO Biotite-H Implant Systems DIO Biotite -H Implant Fixtures will be packaged.

15-11. Intended Use

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

15-12. Substantial Equivalence Comparison

The following are the predicate devices that are substantially equivalent to the Calcium Hydroxylapatite Implant:

K955428	Implant Innovation, Inc.
	3i Hydroxylapatite Coated Standard Thread
K940348	OsteoGraft/D-700
	CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228
K882682	alcitie
	Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San Diego, CA 92121
K852742	Osteograf AR Alveolar Ridge Hydroxylapatite 18-40
	Coors Biomedical Company, 12860 West Cedar Drive,
	Lakewood, CO 80228
K852765	HA-2000
	Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568
K992416	Perioglas-BioGlass Bone Graft Particulate
	U.S. Biomaterials Corp., One Progress Boulevard, Alachua,
	FL 32615
K000149	Novabone-Bioglass Bone Graft Particulate
	U.S. Biomaterials Corp., One Progress Boulevard, Alachua,
	FL 32615
K952922	Biogran Bioactive Glass Synthetic Bone Graft Material
	Orthovita Co., 212 Carnegie Center Drive, Suite 206,
	Princeton, NJ 08540
K921468	PermanMesh Hydroxylapatite Matrix
	CeraMed Corp., 12860 West Cedar Drive, Lakewood, CO 80228
K862061	Osteograf/AR+Permaridge Hydroxylapatite, 18-40
	Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228
K910432	HAPSET Hydroxylapatite Bone Graft Plaster
	Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W.
	Washington Square, Suite 1100, Washington, D.C. 20036

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

The Biotite-H Implant is substantially equivalent to the predicate device sited above.

	Subject Device	Predicate Device
Device Name	DIO DENTAL IMPLANT CO. LTD(DIO Biotite-H Implant System)	IMPLANT INOVATION, INC.(K 955428)
Intended Use	Identical to predicate devices	The implants areindicated for surgical placement inthe upper or lower jawto provide a means for prostheticattachment in single toothrestoration and in partially or fullyedentulous spans withmultiple single teeth, or as aterminal or intermediaryabutment for fixed or removablebridgework, and to retainoverdentures.
Material	Commercially pure titanium GR. 3and GR.4 (ASTM-F-67)	Commercially pure titanium Gr. 3 andGr.4 (ASTM-F-67)
Design	Morse Taper with Thread	Morse Taper with Thread
Screw Threads	YES	YES
Implant ThreadDiameter (mm)	3.8, 4.1, 4.5, 4.8 and 5.3 mm	3.8, 4.5, and 5.3 mm
Collar Height (mm)	1.8	1.8
Lengths (External)	8-14 mm	8-14 mm
Surface Treatment	HA Coating	HA Coating
Gamma sterilized	YES	YES

TECHNOLOGICAL CHARACTERISTIC COMPARISON

Attachments

Screw-retained restoration system	YES	YES
Cemented restoration system	YES	YES
Overdenture restoration	YES	YES
Instruments (surgical and restorative)	YES	YES

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scan or photocopy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DIO Department, DSI, Incorporated C/O Dr. Steve Chang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

MAY 1 6 2008

Re: K073070

Trade/Device Name: DIO Biotite-H Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 14, 2008 Received: May 16, 2008

Dear Dr. Chang:

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.

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

Page 2 - Dr. Chang

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,

Chorts

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

{6}------------------------------------------------

Indication for Use

510(K) Number (if known):

Device Name: DIO Biotite-H Implant System

Indications For Use:

Kim Muly for MSR

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

510(k) Number: KD73070

Prescription Use
(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.