Predicate Devices

K083067, K112540, K110577, K061319, K023952, K050506

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant system and its materials, sizes, and testing. There is no mention of software, algorithms, or any technology that would suggest AI/ML is incorporated.

Therapeutic

Yes.
The device is intended to treat missing teeth and restore mastication, which are therapeutic actions.

Diagnostic

No

Explanation: The device is a dental implant system used to provide support for prosthetic devices in patients with missing teeth, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy, which is a physical hardware component intended for surgical placement.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a dental implant system used to support prosthetic devices in the treatment of missing teeth. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a physical implant made of titanium alloy, designed for surgical placement in the jawbone. This aligns with a medical device, not an IVD.
Lack of IVD characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

Therefore, the One Plus Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

Product codes

DZE

Device Description

The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy 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 material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it.

The One Plus Implant System is available in the following sizes.

Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw arches

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

Non-Clinical Testing

Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Accelerated shelf life testing has been performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2
Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixture.

Key Metrics

Not Found

Predicate Device(s)

K083067, K112540, K110577, K061319, K023952, K050506

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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

September 19, 2014

OsseoFuse, Inc. C/O Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92831

Re: K133050

Trade/Device Name: One Plus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endossesous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 20, 2014 Received: August 21, 2014

Dear Ms. Chung:

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 Federal Register.

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page

510(k) Number (if known) K133050

Device Name One Plus Implant System

Indications for Use (Describe)

The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intental or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

■ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

(K133050)

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 09/17/2014

1. Applicant / Submitter

OsseoFuse, Inc.

5023 North Parkway Calabasas. Calabasas, CA 91302 Tel. 888.446.9995 Fax. 310.356.3183

2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Trade Name: One Plus Implant System
· Common Name: Dental Implant
Classification Name: Endosseous Dental Implant System
· Product Code: DZE
· Classification regulation: 21CFR872.3640

4. Predicate Device:

· MS System by OSSTEM IMPLANT CO., LTD (K083067)
· S-MINI IMPLANT SYSTEM by NEOBIOTECH CO., LTD (K112540)
· OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations Inc. (K110577)
· Spectra System (ScrewDirect Implant) by Implant Direct LLC (K061319)
· Replace One Piece Implant by NOBEL BIOCARE UAS INC. (K023952)
· Lifecore PrimaSolo One-Piece Implant System by Lifecore Biomedical, Inc.(K050506)

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5. Description:

The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy 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 material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it.

The One Plus Implant System is available in the following sizes.

Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5

6. Indication for use:

The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

7. Basis for Substantial Equivalence

The subject device is substantially equivalent to the noted predicate devices based on tabulated device specifications and properties presented. Based on the comparison analysis, the identical intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate devices. There are no significant differences between the One Plus Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.

The comparison chart can be found on the following pages.

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Comparison Chart

	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
510(K) Number	K133050	K083067	K112540	K110577	K061319
Device Name	One Plus Implant System	MS System	S-MINI IMPLANT
SYSTEM	OSSEOFUSE DENTAL
IMPLANT SYSTEM	Spectra System
(ScrewDirect Implants)
Applicant	OsseoFuse Co., Ltd.	OSSTEM Implant Co.,
Ltd.	NEOBIOTECH CO., LTD.	Dynamic Innovations Inc.	Implant Direct LLC
Contract
Manufacturer	KJ Meditech Co., Ltd.	-	-	KJ Meditech Co., Ltd.	-
Indications for
Use	The One Plus Implant
System is intended to use
in the treatment of
missing teeth to support
prosthetic device, such as
artificial teeth, in order to
restore mastication in
partially edentulous
patients. 3.0mm diameter
implants are intended to
be used in central or
lateral mandibular
incisors. The One Plus
Implant System is
intended for single use
only. It is for delayed
loading.	The MS System
(Denture) is intended to
be place in the bone of
the upper or lower jaw
arches to provide support
the prosthetic devices to
restore the patient's
chewing function,
including the denture
stabilization. MS System
(Denture) is intended for
single use only.
The MS System (Narrow
Ridge) is intended to use
in the treatment of
missing mandibular
central and lateral
incisors to support
prosthetic device, such
as artificial teeth, in
order to restore chewing
function in partially
edentulous patients. MS
System (Narrow Ridge)
is intended for single use
only. It is not for	The Cement type is
indicated for use in the
treatment of missing
maxillary lateral incisors or
the mandibular central and
lateral incisors to serve as
temporary support
prosthetic devices during
the healing phase of
permanent endosseous
dental implant, such as
artificial teeth, in order to
restore chewing function in
partially edentulous
patients.	The OsseoFuse Dental
Implant System is intended
for use in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including:
cemented retained, screw
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.	The Spectra Dental
Implant System consists of
one-piece or two-piece
implants for single-stage or
two-stage surgical
procedures that are
intended for use in
partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations and terminal
or intermediate abutment
support for fixed
bridgework. They may be
placed in immediate
function if initial implant
stability can be
established.
The ScrewDirect 3.0mm
implant is indicated for:

An artificial root
structure for single tooth
replacement of mandibular
central and lateral incisors |
| | | immediate loading. | | | and maxillary lateral
incisors.
Multiple tooth
replacements or denture
stabilization. |
| Design | One Piece Implant | One Piece Implant | One Piece Implant | Two Piece Implant | One Piece Implant |
| Appearance | Image: One Piece Implant | Image: One Piece Implant | Image: One Piece Implant | Image: Two Piece Implant | Image: One Piece Implant |
| Material | Ti 6Al 4V ELI, Gr.23 | Titanium Alloy | Titanium Gr. 4 | Ti 6Al 4V ELI, Gr.23 | Titanium Alloy |
| Surface
Treatment | •RBM Treatment on the
fixture body
•TiN coating on the
abutment | RBM Treatment on the
fixture body | RBM Treatment on the
fixture body | •RBM Treatment on the
fixture body
•TiN coating on the
abutment | Roughened - HA blasted |
| Implant Sterile | Yes | Yes | Yes | Yes | Yes |
| Sterilization
Method | Gamma | Gamma | Gamma | Gamma | Gamma |
| Implant
Diameters | 3.00mm, 3.75mm,
4.50mm, 5.25mm | 2.50mm 3.00mm | 2.0mm, 2.5mm, 3.0mm,
3.5mm | 3.75mm, 4.1mm, 4.5mm,
5.25mm | 3.0mm, 3.7mm, 4.7mm,
5.7 mm |
| Implant
Lengths | 11.5mm, 13mm, 14.5mm | 10.0 mm, 13.0mm,
15.0mm | 7.0 - 15.00 mm | 8.5mm - 16.0 mm | 10mm, 13mm, 16mm |
| Product Code | DZE | DZE | DZE | DZE, NHA | DZE |

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	Predicate Device 5	Predicate Device 6
510(K) Number	K023952	K050506
Device Name	Replace One Piece Implant	Lifecore PrimaSolo™ One-Piece Implant System
Applicant	NOBEL BIOCARE UAS INC.	LIFECORE BIOMEDICAL, INC.
Indications for Use	The Replace One Piece Implant is a threaded
one-piece implant with an integrated abutment,
designed for single-stage surgical procedure
and cemented restorations. The Replace One
Piece Implant is intended for immediate load
on single tooth and multiple tooth applications
in good quality bone, to restore chewing
function.	Lifecore Biomedical Dental Implant System
implants are 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.
Specific Intended Uses: The PrimaSolo One-
Piece (3.5-5.0mm) Implant is a threaded one-
piece implant with integrated abutment designed
for single-stage surgical procedure and cemented
restorations. The PrimaSolo One-Piece Implant is
intended for immediate placement and can be
restored with a temporary prosthesis in single
tooth and multiple tooth applications with good
quality bone.
The PrimaSolo One-Piece (3.0mm) Implant is a
threaded one-piece implant with an integrated
abutment designed for single-stage surgical
procedure and is indicated for use in the treatment
of missing maxillary lateral incisors or the
mandibular central and lateral incisors to support
		prosthetic devices, such as artificial teeth, in
order to restore chewing function in partially
		edentulous patients. Mandible central and lateral
incisors must be splinted if using two or more
		3.0mm implants adjacent to one other.
Design	One Piece Implant	One Piece Implant

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Appearance
Material	Titanium Gr. 4	Titanium Alloy
Surface Treatment		RBM Treatment on the fixture body
Implant Sterile	Yes	Yes
Sterilization Method
Implant Diameters	3.5mm, 4.3mm, 5.0mm,	3.0mm, 3.5mm, 4.1mm, 5.0mm
Implant Lengths	10mm, 13mm, 16mm	10.0 mm、11.5mm 13.0mm、15.0mm

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8. Non-Clinical Testing

· Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3.
· Accelerated shelf life testing has been performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2
Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixture.

There might be differences in sterilization parameters, shelf life and manufacturing processes between the subject device and the predicate devices, however, the test results supported that the subject device is substantially equivalent to the predicate devices.

9. Conclusion

The subject device and the predicate devices have intended use and have similar technological characteristics.

Overall, the One Plus Implant System has the following similarities to the predicate devices:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design,
incorporates the same material and the surface treatment.

Based on the similarities, we conclude that the One Plus Implant System is substantially equivalent to the predicate devices.