K Number

Device Name

OSSEOFUSE DENTAL IMPLANT SYSTEM

Manufacturer

DYNAMIC INNOVATIONS INC.

Date Cleared

2011-07-14

(135 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.

Device Description

The OsseoFuse Dental Implant system includes Hexa-Plus fixture, Hexa-Plus abutment, and Lab components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of this system has been treated with R.B.M. Hex-Plus Fixture is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Surface of part to be implanted into bone is treated by RBM (Resorbable Blast Media) method to increase junction strength by increasing the area of bone-implant interface. The tight and precisely fitting implant-abutment relation of the internal hexagon with internal bevel design makes abutment connection a quick and simple procedure.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K032774, K071638, K061410

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard dental implant system made of titanium with a treated surface and mechanical components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device, a dental implant system, replaces missing teeth and provides support for restorations, which are structural and restorative functions rather than therapeutic.

Diagnostic

No
The device is a dental implant system used for supporting dental restorations, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states the system includes physical components made of Titanium intended for surgical implantation, such as the Hexa-Plus fixture and abutment. This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
Device Description: The OsseoFuse Dental Implant System is a device that is surgically implanted into the human body (mandibles and maxillae). It is a physical implant used to support dental restorations.
Intended Use: The intended use is to replace missing teeth and support dental prosthetics, which is a structural and functional purpose within the body, not a diagnostic one based on analyzing specimens.

The description clearly indicates a surgically implanted device for structural support, which falls under the category of medical devices, but not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

Hex-Plus Fixture is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Surface of part to be implanted into bone is treated by RBM (Resorbable Blast Media) method to increase junction strength by increasing the area of bone-implant interface.

The tight and precisely fitting implant-abutment relation of the internal hexagon with internal bevel design makes abutment connection a quick and simple procedure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw arches, 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)

All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the OsseoFuse Dental Implant System possess mechanical strength at least equivalent to the predicate devices.

Among the information and data presented in this 510(k) submission to support the substantial equivalence of the OsseoFuse Dental Implant System to the specified predicate devices, fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the OsseoFuse Dental Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use.

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.

K032774, K071638, K061410

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

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.

Summary

OsseoFuse Dental Implant System 510(K)

Kilo577
Dynamic Innovations Inc.

JUL 1 4 2011

510(K) Summary

Submitter

Dynamic Innovations Inc. Kelvin Yoo 5023 North Parkway Calabasas, Calabasas, CA 91302 Email: Kelviny@diilv.com Tel. 888) 446 - 9995 Fax. 310) 356-3183

Official Correspondent Kodent Inc. April Lee . 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-01116

Device Information

Trade Name: OsseoFuse Dental Implant System .
Common Name: Endosseous dental implant .
Classification Name: Implant, Endosseous, Root-Form .
Product Code: DZE .
Regulation Number: 872.3640 .
Device Class: Class II .
Date of submission: 1/19/11 .

General Description

The tight and precisely fitting implant-abutment relation of the internal hexagon with internal bevel design makes abutment connection a quick and simple procedure.

Indication for Use

The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained,

or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This er or en is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

RENOVA™ Internal Hex Implant System (Lifecore Biomedical, Inc.; K032774) .
BioHorizons Internal Implant System (Abutments) (BioHorizons Implant System, Inc.; K071638) .
Zimmer Dental Implant System (Abutments) (Zimmer Dental, Inc. ;K061410) .

Comparison to Predicate Devices:

1. RENOVA™ Internal Hex Implant System
  The OsseoFuse Dental Implant system has a substantially equivalent intended use as the identified predicates (K032774). This dental implant system made of titanium and the surface has been treated with RBM. It is intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The OsseoFuse Dental Implant systems are similar in fundamental scientific technology to the predicate devices (K032774) in that they all have been designed, manufactured and tested in compliance production is Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment. The subject and predicate devices are similar in size, materials, surface treatment, and are sterilized via gamma irradiation. The OsseoFuse Dental Implant system and the predicates include instruments to assist with the implant procedure.

1. BioHorizons Internal Implant System (Abutments)
  The OsseoFuse Dental Implant system (Abutments) has a substantially equivalent as the identified predicate (K071638) especially in size, materials, and surface treatment.
1. Zimmer Dental Implant System (Angled Abutment)
  The OsseoFuse Dental Implant system (Angled Abutment) has substantially equivalent as the identified predicate (K061410) especially in size, materials, and angulations.

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Substantial Equivalence Comparison chart

..............................................................................................................................................................................

	Subject Device	Predicate Device
510(K) Number	N/A	K032774
Device Name	OsseoFuse Dental Implant System	RENOVAT™ Internal Hex Implant System
Manufacturer	KJ Meditech Co., Ltd.	Lifecore Biomedical, Inc.
Indications for Use	Intended for use in partially or
fully edentulous mandibles and
maxillae, in support of single or
multiple-unit restorations
including; cement-retained, screw-
retained, or overdenture
restorations, and terminal or
intermediate abutment support for
fixed bridgework.	Intended for use in partially or
fully edentulous mandibles and
maxillae, in support of single or
multiple-unit restorations
including; cement-retained, screw-
retained, or overdenture
restorations, and terminal or
intermediate abutment support for
fixed bridgework.
Design	• Implant Type: Bone Level Implant
• Connection Type: Internal Hexagon
• Neck Design: Straight walled neck with micro-thread provides crestal seal.
• 1mm smooth titanium surface allows soft tissue maintenance.
• Body Design: Tapered design enables placement near impringing anatomical structures while maximizing prosthetic table diameter for natural emergence profile.	• Implant Type: Bone Level Implant
• Connection Type: Internal Hexagon
• Neck Design: Straight walled neck with circumferential thread provides crestal seal.
• 1mm smooth titanium surface allows soft tissue maintenance.
• Body Design: Tapered design enables placement near impringing anatomical structures while maximizing prosthetic table diameter for natural emergence profile.
Fixture	Image: dental implant	Image: dental implant
	3.75mm, 4.1mm, 4.5mm, 5.25mm
8.5 - 16.0 mm	3.75mm, 4.5mm, 4.75 mm
8.5 - 16.0 mm

Healing Abutment	Image: Healing Abutment 1	Image: Healing Abutment 2
	4.0mm, 4.7mm, 5.5mm
3mm, 5mm, 7mm	4.5mm, 4.75mm
1.5mm, 3mm, 5mm
Ball Abutment	Image: Ball Abutment 1	Image: Ball Abutment 2
	3.58mm
3mm	3.75mm, 4.5mm, 4.75mm
1mm, 2mm, 3mm, 4mm
Abutment Screw	Image: Abutment Screw 1	Image: Abutment Screw 2
	1.25mmD Hex	1.25mmD Hex
Endosseous Implant
Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment	RBM Treatment on the fixture body	RBM Treatment on the fixture body
Implant Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma

...

BioHorizons Internal Implant System (Abutments) -

	Subject Device	Predicate Device
510(K) Number	N / A	K071638
Device Name	OsseoFuse Dental Implant System	BioHorizons Tapered Internal Implant
System
Manufacturer	KJ Meditech Co., Ltd.	BioHorizons Implant System, Inc.
One-Step Abutment	Image: One-Step Abutment Subject Device	Image: One-Step Abutment Predicate Device
	4.5mm, 5.25mm, 6.0mm	3.5mm, 4.5mm, 5.7mm
	7.95mm, 1.62mm	8mm , 1.5mm
		TiN coating
Final Cement Abutment	Image: Final Cement Abutment Subject Device	Image: Final Cement Abutment Predicate Device
	4.5mm, 5.25mm, 6.0mm	4.5mm
	12.27mm, 2mm	10mm, 2mm
	TiN coating	TiN coating

Straight Abutment	Image: Straight Abutment	Image: Straight Abutment
	3.75mm	3.5mm, 4.5mm, 5.7mm
	12mm	10mm
	TiN coating	TiN coating
Temporary Abutment	Image: Temporary Abutment	Image: Temporary Abutment
	4.75mm	3.5mm, 4.5mm, 5.7mm
	11.45mm	10mm

Endosseous Implant
Abutment Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23

Zimmer Dental Implant System (Angled Abutment) -
.

	Subject Device	Predicate Device
510(K) Number	N / A	K061410
Device Name	OsseoFuse Dental Implant System	Zimmer Dental Implant System
Manufacturer	KJ Meditech Co., Ltd.	Zimmer Dental, Inc.
Appearance	Image: Subject Device Appearance	Image: Predicate Device Appearance
Diameter	5.25mm	5.25mm
Length	11.40mm	11.40mm
Angulation	17°	20°
Surface treatment	TiN coating	-
Endosseous Implant
Abutment Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23

Safety and Effectiveness

OsseoFuse Dental Implant System is substantially equivalent to predicate devices when the devices have the same intended use and the same technological characteristics as the previously cleared predicate devices, and it can be demonstrated that the devices are as safe and effective as the predicate devices, and that the new device does not raise different questions regarding safety and effectiveness as compared to the redicate devices. The OsseoFuse Dental Implant System, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.

Performance Data:

Conclusion

The OsseoFuse Dental Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or risks cannot be substantiated. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, OsseoFuse Dental Implant System and its predicate devices are believed to be substantially equivalent.

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized representation of a human figure, with three lines representing the head, body, and legs. The figure is facing to the right and appears to be in motion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dynamics Innovations Incoporated C/O Ms. April Lee Consultant Kodent Incorporated 325 North Puente Street, Unit B Brea, California 92821

JUL 1 4 2011

Re: K110577

Trade/Device Name: OsseoFuse Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 17, 2011 Received: June 27, 2011

Dear Ms. 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 Eederal Register.

Page 2 -- Ms. 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/Centers Offices/CDRH/CDRHOffic es/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,

Anton hum

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

Dynamic Innovations Inc.

Indication for Use

510(K) Number (if known): K110577

Device Name: OsseoFuse Dental Implant System

Indication for Use:

Prescription Use

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(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

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(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

${^{38}}_{510(k)}$ Number: K110577