K Number

Device Name

FIN-S MICROIMPLANT

Manufacturer

CREEKSIDE ORTHODONTICS

Date Cleared

2013-02-21

(336 days)

Product Code

OAT

Regulation Number

872.3640

Intended Use

The Fin-S Orthodontic/Dental Microimplant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. This device is intended for single use only.

Device Description

The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths. Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.

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

K060126, K042965, K033767, K042289

Reference Devices

K060126, K042965, K033767, K042289

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material, design, and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.

Therapeutic

Yes
The device is intended to facilitate the orthodontic movement of teeth, which is a therapeutic intervention to correct dental alignment.

Diagnostic

The device is a microimplant used for orthodontic anchorage, not for diagnosing medical conditions. Its function is to facilitate the movement of teeth, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical implant made of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5, with specific physical characteristics and dimensions. It is a hardware device.

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 is to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed directly on the patient's body.
Device Description: The device is a physical implant made of titanium alloy, designed to be surgically placed in the jaw.
Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not perform any such tests. It is a physical implant used for mechanical support.

The information provided clearly describes a surgical implant used for orthodontic treatment, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OAT

Device Description

The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths: Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaws

Indicated Patient Age Range

adolescents greater than 12 years of age and adults

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 Data Regarding Cytotoxicity: Cytotoxicity testing of the Fin-S Orthodontic/Dental Microimplant was performed utilizing a direct-contact test according to ISO 10993-5:1999 and ISO 10993-12:2004. Specifically, an established cell line was obtained from a recognized cell repository. These cells were cultured according to accepted methods, and the cultures were exposed to direct contact with the microimplant which is composed of Ti6Al4V titanium based alloy. Cytotoxicity was evaluated by microscopically examining the cell cultures for visual clues of cytotoxicity when compared to a control culture. The Fin-S Orthodontic/Dental Microimplant demonstrated to be non-cytotoxic and is therefore biocompatible.

Sterilization Validation Testing: Sterilization testing of the devices was performed using Bacillus atrophaeus and Geobacillus Stearothermophilus spore strips and inoculated microimplants using the same organisms. The moist heat sterilization instructions provided in the directions for use have been validated to a Sterility Assurance Level of 10-5 according to ISO 17665-1 and ISO 17665-2 with the overkill method. Additionally, the dry heat instructions provided in the directions for use have been validated to a Sterility Assurance Level of 10-5 according to ISO 20857 with the overkill method.

Key Metrics

Not Found

Predicate Device(s)

K060126, K042965, K033767, K042289

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

FEB 2 2013

Creekside Orthodontics 136 E. Mallard Dr. Boise, Idaho 83706 Contact Name: Dr. John T. Kalange 208-342-0212 . 208-342-0323 (Fax) Summary Preparation Date: 1/24/2013 510(K) Summary of Safety and Effectiveness

12086

1. Identification of the Device:

Proprietary-Trade Name: Fin-S Orthodontic/Dental Microimplant Classification Name: Implant, Endosseous, Product Code OAT Common/Usual Name: Dental Implant

2. Equivalent Legally Marketed Devices:

Dentaurumn Tomas-pin (K042965). Jeil Medical Dual Top Anchor SystemScrews (K033767), IMTEC MIDI Ortho (K042289) Dentos AbsoAnchor(K060126)

3. Description of the Device:

K120861

4. Indications for Use:

5. Potential Adverse Affects and Complications (common to all devices of this tvpe):

- Metal sensitivity or allergic reaction
- Pain or discomfort due to presence of device
- Infection

6. Non-clinical Testing Data Regarding Cytotoxicity:

Cytotoxicity testing of the Fin-S Orthodontic/Dental Microimplant was performed utilizing a direct-contact test according to ISO 10993-5:1999 and ISO 10993-12:2004. Specifically, an established cell line was obtained from a recognized cell repository. These cells were cultured according to accepted methods, and the cultures were exposed to direct contact with the microimplant which is composed of Ti6Al4V titanium based alloy. Cytotoxicity was evaluated by microscopically examining the cell cultures for visual clues of cytotoxicity when compared to a control culture. The Fin-S Orthodontic/Dental Microimplant demonstrated to be non-cytotoxic and is therefore biocompatible.

7. Sterilization Validation Testing:

Sterilization testing of the devices was performed using Bacillus atrophaeus and Geobacillus Stearothermophilus spore strips and inoculated microimplants using the same organisms. The moist heat sterilization instructions provided in the directions for use have been validated to a Sterility Assurance Level of 10 5 according to ISO 17665-1 and ISO 17665-2 with the overkill method. Additionally, the dry heat instructions provided in the directions for use have been validated to a Sterility Assurance Level of 10 ~ according to ISO 20857 with the overkill method.

8. Safety and Effectiveness, Comparisons to Predicate Devices
Product Comparison:

Device	Fin-S	Absoanchor	Tomas-pin	Dual Top	MDI Ortho
Name,	Orthodontic			Anchor
	Dental			System
	Microimplant
Product	OAT	DZE	DZE	DZE	DZE
Code -

Applicant	Dr. John T.	Dentos, Inc	Dentarum	Jeil Medical	IMTEC Corp
	Kalange			Group


510(K) #	K120861	K060126	K042965	K033767	K042289

Intended	Provide a fixed	Provide a fixe	Provide a fixed	Provide a	Provide a fixed
Use	anchorage point	anchorage	anchorage point	fixed	anchorage point
	for attachment	point for	for attachment of	anchorage	for attachment
	of orthodontic	attachment of	orthodontic	point for	of orthodontic
	appliances to	orthodontic	appliances to	attachment of	appliances to
	facilitate the	appliances to	ﻠ
facilitate the	orthodontic	facilitate the
	orthodontic	facilitate the	orthodontic	appliances to	orthodontic
	movement of	orthodontic	I movement of	facilitate the	movement of
	teeth	movement of	teeth	orthodontic	teeth
		teeth		movement of
				teeth
Sterility	Non-sterile:	Non-sterile:	Sterile	Non-sterile:	Sterile
	steam sterilize	steam sterilize		steam sterilize
	before use	before use		before use

Diameter	: 1.4mm	1.2mm-1.8mm	1.2mm	1.4-2.0mm	1.8mm


Length	Round Head	4.0mm-12mm	8.0mm-10mm	6.0mm-12mm	6.0mm-10mm
	6mm-12mm
	Palatal Head
	4mm-10mm
	Reverse Thread
	6mm-12mm
	Long Head
	6mm-12mm

9. Conclusion Statement:

The information provided in this submission demonstrates the substantial equivalence of the Fin-S Orthodontic/Dental Microimplant to the identified predicate devices.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 21, 2013

John T. Kalange, DDS, MS Owner Creekside Orthodontics 136 East Mallard Drive BOISE ID 83706

Re: K120861

Trade/Device Name: Fin-S Orthodontic/Dental Microimplant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: January 24, 2013 Received: February 12, 2013

Dear Dr. Kalange:

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.

Page 2 - Dr. Kalange

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 devicerelated 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/CentersOffices/CDRH0ffices/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,

Mary S. Runner
Susan Runner, DOS,MA 2013.02.21
14:20:53 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

Indications for Use Form

510(k) Number (if known): _ K120861

Device Name: Fin-S Orthodontic/Dental Microimplant

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Runner 2013:02.14 ਹੈ ਹੋ 14:02:16 -05'00'

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120861

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