K110275 · Forestadent Bernhard Forster GmbH · OAT · Jun 3, 2011 · Dental
Device Facts
Record ID
K110275
Device Name
ORTHO EASY PIN
Applicant
Forestadent Bernhard Forster GmbH
Product Code
OAT · Dental
Decision Date
Jun 3, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
Ortho Easy Pin is a titanium alloy endosseous screw providing temporary orthodontic anchorage. Device features self-drilling/self-trapping thread and cross-shaped head slot for wire/elastic attachment; includes soft tissue protection sleeve. Used by orthodontists/dentists in clinical settings; inserted manually or mechanically into bone. Torque feedback provided during insertion; screw removed post-treatment. Benefits include stable anchorage for tooth movement. Device supplied non-sterile; requires steam sterilization before use.
Clinical Evidence
Bench testing only. Evaluated torque levels, insertion forces, and insertion lengths compared to predicate devices. Assessed risk of tooth root damage; results indicated thread peak design provides protective function. Torque measurements confirmed device withstands active orthodontic forces without fracture, showing performance comparable to predicates.
Technological Characteristics
Material: Titanium alloy (ASTM F 136). Dimensions: 1.7 mm diameter; 6-12 mm lengths. Design: Self-drilling/self-trapping thread; cross-shaped head slot; soft tissue protection sleeve. Energy: Manual/mechanical insertion. Sterilization: Steam (non-sterile supply). Standards: ISO 7405.
Indications for Use
Indicated for patients in need of teeth alignment correction requiring a temporary fixed anchorage point for orthodontic appliances. For professional use by dentists or orthodontists only.
Regulatory Classification
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.
Special Controls
*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.
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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
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:
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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 to<br>provide a fixed anchorage<br>point for the attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of the teeth. It is<br>used temporarily and is<br>removed after orthodontic<br>treatment has been completed.<br>The screws are intended for<br>single use only. For use in<br>adults over the age of 12. | This device is intended to<br>provide a fixed anchorage<br>point for the attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of the teeth. It is<br>used temporarily and is<br>removed after orthodontic<br>treatment has been<br>completed. The screws are<br>intended for single use only. | This device is intended to<br>provide a fixed anchorage<br>point for the attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of the teeth. It is<br>used temporarily and is<br>removed after orthodontic<br>treatment has been<br>completed. The screws are<br>intended for single use<br>only. |
| Indications for<br>use | See intended use | See intended use | See intended use |
| Target<br>population | Patients in need of teeth<br>alignment correction | Patients in need of teeth<br>alignment correction | Patients in need of teeth<br>alignment correction |
| Anatomical sites | | | |
| Location of use<br>(hospital, home,<br>ambulance, etc) | Use only for professional<br>dentists or orthodontics. | Use only for professional<br>dentists or orthodontics. | Use only for professional<br>dentists or orthodontics. |
| Energy used<br>and/or delivered | NA | NA | NA |
| Human factors | | | |
# Substantial Equivalence Comparison Table
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| Design | diameter ranges from 1.4 - 2<br>mm, length ranges from<br>6 - 12 mm | diameter 1,2 mm,<br>length ranges from<br>6 - 10 mm | diameter 1.7 mm,<br>length ranges from<br>6 - 12 mm |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | self-trapping/self-drilling<br>screw | self-drilling screw | self-trapping/self-drilling<br>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<br>grade according ASTM- F 136<br>is accepted for endosseous<br>implant | Titanium alloy in medical<br>grade according ASTM- F<br>136 is accepted for<br>endosseous implant | Titanium alloy in medical<br>grade according ASTM- F<br>136 is accepted for<br>endosseous implant |
| Compatibility<br>with the<br>environment and<br>other devices | Medical grade titanium alloy<br>according to ASTM- F 136 is<br>accepted for endosseous<br>implants | Medical grade titanium alloy<br>according to ASTM- F 136 is<br>accepted for endosseous<br>implants | Medical grade titanium<br>alloy according to ASTM-<br>F 136 is accepted for<br>endosseous implants |
| Sterility | non-sterile | non-sterile | non-sterile |
| Electrical safety | NA | NA | NA |
| Mechanical<br>safety | tensile strength of material<br>according to ASTM F-136,<br>Relevant diameter range 1.4<br>mm - 2 mm | tensile strength of material<br>according to ASTM F-136 | tensile strength of material<br>according to ASTM F-136,<br>diameter 1,7 mm, fracture-<br>proof during implantation.<br>See also material test<br>reports comparing torque ir<br>different 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: _______________________________________________________________________________________________________________________________________________________________
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