Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and function of a physical screw for orthodontic anchorage. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is used to facilitate the orthodontic movement of teeth, which is a therapeutic process aimed at correcting dental misalignments.

Diagnostic

No

The device is described as an anchorage point for orthodontic appliances, used to facilitate tooth movement. Its function is mechanical and structural support, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical implantable screw made of titanium alloy, which is a hardware component.

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 the device is for providing 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 description details a physical screw made of titanium alloy, designed to be inserted into bone. It describes its physical features and how it is used in a surgical/dental procedure.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples for diagnostic purposes. This device is used in vivo (inside the body) as a physical anchor.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only.

Product codes

OAT

Device Description

The Ortho Easy Pin is designed for use in orthodontic treatments as element of anchorage. The screws are made of titanium alloy. The slots in the screw head are cross-shaped. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed to the screw head using an elastic band or steel ligature. A retention groove below the slots serves as the anchor for fixing elements in the slot. The thread of the Pin is self-trapping and self-drilling. The Pin is inserted and screwed into the bone either manually or mechanically. To insert the screw, the hexagon head of the screw is picked up using an instrument. The sleeve between the thread and the functional head serves to protect the soft tissue. These screws are supplied non-sterile. Therefore, the device must be sterilized prior to use. Steam sterilization is recommended. The device is available in different lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional dentists or orthodontics.

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)

Testing was done to determine the torque levels, forces and insertion lengths while inserting OrthoEasy® pin. The level of torque is comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw) which were investigated with the measurement equipment under the same parameter. Testing was also done to determine the effect of impact on tooth roots. This testing found the risk of root damage while inserting an OrthoEasy® pin into a root is not justified as the thread peak is not able to cut the tooth. In conclusion it can be said that the thread peak of the OrthoEasy® pin has a protective function.

The OrthoEasy® pin features a low insertion level at the beginning. Due to the design parameters, the torque increases at the end of the insertion process. This provides feedback to the doctor during the insertion process. The amount of torque is clearly far from the load limit of 30 Ncm. No fracture occurred during our measurements. The measurement results that the OrthoEasy® pin withstands the active forces during an orthodontic treatment. The level of torque is comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw) which were investigated with the measurement equipment under the same parameter. Therefore it is to estimed OrthoEasy® pin will show the same clinical results like the other screws.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062733, K033767

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

0

KII 0275

510(k) SUMMARY (as required by 807.92(c))

JUN - 3 2011

Regulatory Correspondent:

AJW Technology Consultants Inc 962 Allegro Lane Apollo Beach, FL 33572 Tanya O'Brien tmobrien@ajwtech.com 813-645-2855 813-677-4787

Bernhard Forster GmbH Westliche Karl-Fredrichstrasse 151 75172 Pforzheim, Germany Michael Fiess Michael.fiess(a)forestadent.com

January 18, 2011

Ortho Easy Pin

Implant, endosseous

OAT

The device is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only.

The Ortho Easy Pin is designed for use in orthodontic treatments as element of anchorage. The screws are made of titanium alloy. The slots in the screw head are cross-shaped. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed to the screw head using an elastic band or steel ligature. A retention groove below the slots serves as the anchor for fixing elements in the slot. The thread of the Pin is self-trapping and self-drilling. The Pin is inserted and screwed into the bone either manually

Date of Summary:

Submitter of 510(k):

Trade/Proprietary Name:

Classification Name:

Product Code:

Intended Use:

Device Description:

1

or mechanically. To insert the screw, the hexagon head of the screw is picked up using an instrument. The sleeve between the thread and the functional head serves to protect the soft tissue. These screws are supplied non-sterile. Therefore, the device must be sterilized prior to use. Steam sterilization is recommended. The device is available in different lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags.

Tomas PIN (K062733), Dentaurum; Dual Top Anchor System Screws (K033767), Jeil Medical Corporation

All reports show that the Ortho Easy Pin is equivalent to devices currently on the market. They are made of the same material and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices. This device is manufactured from titanium ASTM-F 136-98 which is generally used in this kind of bone screw. Similar grade 5 titanium alloy devices are manufactured and sold around the world. This device is substantially equivalent in design, material, intended use and function to the products listed as predicate devices.

Testing was done to determine the torque levels, forces and insertion lengths while inserting OrthoEasy® pin. The level of torque is comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw) which were investigated with the measurement equipment under the same parameter. Testing was also done to determine the effect of impact on tooth roots. This testing found the risk of root damage while inserting an OrthoEasy® pin into a root is not justified as the thread peak is not able to cut the tooth. In conclusion it can be said that the thread peak of the OrthoEasy® pin has a protective function.

The OrthoEasy® pin features a low insertion level at the beginning. Due to the design parameters, the torque increases at the end of the insertion process. This provides feedback to the doctor during the

Predicate Device:

Substantial Equivalence:

Performance Testing

Conclusion

2

insertion process. The amount of torque is clearly far from the load limit of 30 Ncm. No fracture occurred during our measurements. The measurement results that the OrthoEasy® pin withstands the active forces during an orthodontic treatment. The level of torque is comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw) which were investigated with the measurement equipment under the same parameter. Therefore it is to estimed OrthoEasy® pin will show the same clinical results like the other screws.

	Jeil Medical Corporation	Dentaurum Inc. Tomas PIN	Bernhard Forster GmbH
	Dual Top Anchor System	(Temporary Orthodontic	Ortho Easy PIN
	Screws	Micro anchor system )
Intended use	This device is intended to
provide a fixed anchorage
point for the attachment of
orthodontic appliances to
facilitate the orthodontic
movement of the teeth. It is
used temporarily and is
removed after orthodontic
treatment has been completed.
The screws are intended for
single use only. For use in
adults over the age of 12.	This device is intended to
provide a fixed anchorage
point for the attachment of
orthodontic appliances to
facilitate the orthodontic
movement of the teeth. It is
used temporarily and is
removed after orthodontic
treatment has been
completed. The screws are
intended for single use only.	This device is intended to
provide a fixed anchorage
point for the attachment of
orthodontic appliances to
facilitate the orthodontic
movement of the teeth. It is
used temporarily and is
removed after orthodontic
treatment has been
completed. The screws are
intended for single use
only.
Indications for
use	See intended use	See intended use	See intended use
Target
population	Patients in need of teeth
alignment correction	Patients in need of teeth
alignment correction	Patients in need of teeth
alignment correction
Anatomical sites
Location of use
(hospital, home,
ambulance, etc)	Use only for professional
dentists or orthodontics.	Use only for professional
dentists or orthodontics.	Use only for professional
dentists or orthodontics.
Energy used
and/or delivered	NA	NA	NA
Human factors

Substantial Equivalence Comparison Table

3

| Design | diameter ranges from 1.4 - 2
mm, length ranges from
6 - 12 mm | diameter 1,2 mm,
length ranges from
6 - 10 mm | diameter 1.7 mm,
length ranges from
6 - 12 mm |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | self-trapping/self-drilling
screw | self-drilling screw | self-trapping/self-drilling
screw |
| Standards met | ISO 7405 | ISO 7405 | ISO 7405 |
| Materials | titanium alloy ASTM F 136 | TITAN grade 5 3.7165 | titanium alloy ASTM F 136 |
| Biocompatibility | Titanium alloy in medical
grade according ASTM- F 136
is accepted for endosseous
implant | Titanium alloy in medical
grade according ASTM- F
136 is accepted for
endosseous implant | Titanium alloy in medical
grade according ASTM- F
136 is accepted for
endosseous implant |
| Compatibility
with the
environment and
other devices | Medical grade titanium alloy
according to ASTM- F 136 is
accepted for endosseous
implants | Medical grade titanium alloy
according to ASTM- F 136 is
accepted for endosseous
implants | Medical grade titanium
alloy according to ASTM-
F 136 is accepted for
endosseous implants |
| Sterility | non-sterile | non-sterile | non-sterile |
| Electrical safety | NA | NA | NA |
| Mechanical
safety | tensile strength of material
according to ASTM F-136,
Relevant diameter range 1.4
mm - 2 mm | tensile strength of material
according to ASTM F-136 | tensile strength of material
according to ASTM F-136,
diameter 1,7 mm, fracture-
proof during implantation.
See also material test
reports comparing torque ir
different materials. |
| Chemical safety | NA | NA | NA |
| Thermal safety | NA | NA | NA |
| Radiation safety | NA | NA | NA |

. .

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Forestadent Bernhard Forster GmbH C/O Ms. Tanya O'Brien, RN/BSN/CPAN Regulatory Correspondent AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

JUN - 3 2011

Re: K110275 Trade/Device Name: Ortho Easy Pin Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: May 20, 2011

Dear Ms. O'Brien:

Received: May 23, 2011

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.

5

Page 2- Ms. O'Brien

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/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.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,

Mr for

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

6

Indications for Use

510(k) Number (if known): K110275

Device Name: Ortho Easy Pin

Indications For Use: The device is intended to provide a fix anchorage point for attachment of orthodontic appliance to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended to be single used only.

Prescription Use x Presemplion Ose x
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the control of the contraction of the comments of the comments of the comments of the

Supra Roanes

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

K-110275 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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