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.

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.

AI/ML Overview

The Ortho Easy Pin is a temporary anchorage device used in orthodontics. The device's performance was evaluated through a series of tests to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria against a specific clinical outcome.

Here's a breakdown of the information provided in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on comparison to predicate devices, there aren't explicit numeric "acceptance criteria" defined in the same way one might find for a diagnostic device's sensitivity or specificity. Instead, the acceptance is based on demonstrating comparable performance and characteristics to existing, legally marketed devices.

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Ortho Easy Pin)
Material	Titanium alloy (ASTM F 136 or Grade 5 TITAN 3.7165)	Titanium alloy ASTM F 136
Dimensions	Diameter: 1.2 - 2 mm, Length: 6 - 12 mm (across predicates)	Diameter: 1.7 mm, Length: 6 - 12 mm
Performance (Mechanism)	Self-trapping/self-drilling screw mechanism	Self-trapping/self-drilling screw mechanism
Torque Levels (Insertion)	Comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw)	The level of torque is comparable to predicate devices. Low insertion level at the beginning, torque increases at the end of insertion, providing feedback. Torque amount is "clearly far from the load limit of 30 Ncm." No fracture occurred during measurements.
Resistance to Active Forces	Withstands active forces during orthodontic treatment (implied by predicate use)	Measurement results indicate the OrthoEasy® pin withstands active forces during orthodontic treatment.
Root Damage Risk	Minimal/acceptable risk of root damage (implied by predicate use)	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. The thread peak has a "protective function."
Sterility	Non-sterile (requiring sterilization prior to use)	Supplied non-sterile. Steam sterilization recommended prior to use.
Biocompatibility	Accepted for endosseous implant (Titanium alloy ASTM F 136)	Titanium alloy in medical grade according to ASTM- F 136 is accepted for endosseous implant.
Intended Use	Fixed anchorage point for orthodontic appliances, temporary, single-use, removable after treatment	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.

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

The document does not explicitly state the numerical sample size for the mechanical performance testing (torque, impact on tooth roots, resistance to active forces). It only mentions "our measurements" and "All reports."

The data provenance is from Bernhard Forster GmbH (Germany), the manufacturer. The studies appear to be prospective bench testing conducted specifically for this submission, comparing the Ortho Easy Pin to the two predicate devices under the same parameters. There is no mention of human subject data or clinical trials in this summary.

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

This submission pertains to a medical device's mechanical and material properties, not a diagnostic algorithm. Therefore, there is no "ground truth" in the clinical imaging sense, nor were experts used to establish it for a test set. The validation relies on engineering and material standards (ISO 7405, ASTM F-136) and comparative mechanical testing.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic study requiring human adjudication of findings. Mechanical test results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a mechanical medical device, not an AI-assisted diagnostic tool for imaging interpretation.

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

Not applicable. This is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or validation for this device is based on:

Material standards: ASTM F-136 for titanium alloy.
Performance standards: ISO 7405.
Comparative mechanical testing: Measuring torque, force resistance, and impact characteristics against predicate devices.
Biocompatibility: Accepted status of ASTM F-136 titanium alloy for endosseous implants.

8. The Sample Size for the Training Set

Not applicable. There is no training set for this type of mechanical device submission, as it does not involve machine learning or AI.

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

Not applicable, as there is no training set.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a comparative mechanical and material testing study. The goal of the study was to demonstrate substantial equivalence to two predicate devices: Tomas PIN (K062733) from Dentaurum and Dual Top Anchor System Screws (K033767) from Jeil Medical Corporation.

The study involved:

Material Analysis: Confirming the Ortho Easy Pin is made of titanium alloy ASTM F 136, a material already accepted and widely used in similar bone screws and equivalent to the predicate devices.
Mechanical Performance Testing:
- Torque Measurements: The Ortho Easy Pin was tested to determine its insertion torque levels, and these were compared to the predicate devices. The study found the torque levels to be comparable and "clearly far from the load limit of 30 Ncm," with no fractures occurring.
- Force Resistance: Measurements were performed to ensure the pin withstands active forces during orthodontic treatment.
- Impact on Tooth Roots: Testing was conducted to assess the risk of root damage. This test concluded that the thread peak of the Ortho Easy Pin has a protective function and is not able to cut the tooth, thus not causing unjustified root damage.
Design and Intended Use Comparison: A detailed table compared the design parameters (dimensions, self-drilling/self-tapping nature), intended use, indications for use, target population, and other characteristics of the Ortho Easy Pin to the predicate devices, showing strong similarities.
Biocompatibility: The use of ASTM F-136 titanium alloy, an accepted material for endosseous implants, ensured biocompatibility.

Conclusion of the Study:
The overall conclusion from the testing and comparison was that the Ortho Easy Pin is "substantially equivalent in design, material, intended use and function to the products listed as predicate devices." The comparable torque levels led to the estimation that "OrthoEasy® pin will show the same clinical results like the other screws."

Summary

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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

Date of Summary:

Submitter of 510(k):

Trade/Proprietary Name:

Classification Name:

Product Code:

Intended Use:

Device Description:

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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

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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 toprovide a fixed anchoragepoint for the attachment oforthodontic appliances tofacilitate the orthodonticmovement of the teeth. It isused temporarily and isremoved after orthodontictreatment has been completed.The screws are intended forsingle use only. For use inadults over the age of 12.	This device is intended toprovide a fixed anchoragepoint for the attachment oforthodontic appliances tofacilitate the orthodonticmovement of the teeth. It isused temporarily and isremoved after orthodontictreatment has beencompleted. The screws areintended for single use only.	This device is intended toprovide a fixed anchoragepoint for the attachment oforthodontic appliances tofacilitate the orthodonticmovement of the teeth. It isused temporarily and isremoved after orthodontictreatment has beencompleted. The screws areintended for single useonly.
Indications foruse	See intended use	See intended use	See intended use
Targetpopulation	Patients in need of teethalignment correction	Patients in need of teethalignment correction	Patients in need of teethalignment correction
Anatomical sites
Location of use(hospital, home,ambulance, etc)	Use only for professionaldentists or orthodontics.	Use only for professionaldentists or orthodontics.	Use only for professionaldentists or orthodontics.
Energy usedand/or delivered	NA	NA	NA
Human factors

Substantial Equivalence Comparison Table

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Design	diameter ranges from 1.4 - 2mm, length ranges from6 - 12 mm	diameter 1,2 mm,length ranges from6 - 10 mm	diameter 1.7 mm,length ranges from6 - 12 mm
Performance	self-trapping/self-drillingscrew	self-drilling screw	self-trapping/self-drillingscrew
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 medicalgrade according ASTM- F 136is accepted for endosseousimplant	Titanium alloy in medicalgrade according ASTM- F136 is accepted forendosseous implant	Titanium alloy in medicalgrade according ASTM- F136 is accepted forendosseous implant
Compatibilitywith theenvironment andother devices	Medical grade titanium alloyaccording to ASTM- F 136 isaccepted for endosseousimplants	Medical grade titanium alloyaccording to ASTM- F 136 isaccepted for endosseousimplants	Medical grade titaniumalloy according to ASTM-F 136 is accepted forendosseous implants
Sterility	non-sterile	non-sterile	non-sterile
Electrical safety	NA	NA	NA
Mechanicalsafety	tensile strength of materialaccording to ASTM F-136,Relevant diameter range 1.4mm - 2 mm	tensile strength of materialaccording to ASTM F-136	tensile strength of materialaccording to ASTM F-136,diameter 1,7 mm, fracture-proof during implantation.See also material testreports comparing torque irdifferent materials.
Chemical safety	NA	NA	NA
Thermal safety	NA	NA	NA
Radiation safety	NA	NA	NA

. .

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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.

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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

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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: _______________________________________________________________________________________________________________________________________________________________

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.