OrthoEasy Pal; OrthoEasy Pal Long Neck
Device Facts
| Record ID | K260268 |
|---|---|
| Device Name | OrthoEasy Pal; OrthoEasy Pal Long Neck |
| Applicant | Bernhard Förster GmbH (Bernhard Foerster Ltd.) |
| Product Code | OAT · Dental |
| Decision Date | May 19, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
FORESTADENT OrthoEasy® anchorage screw is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component.
Device Story
OrthoEasy Pal and OrthoEasy Pal Long Neck are titanium alloy (Ti6Al4V) endosseous orthodontic anchorage screws. Device features cylindrical body, sharp conical apex, and self-tapping/self-drilling threads for non-surgical insertion. Head design is octagonal with internal thread for precise torque transfer during placement. Includes soft tissue protection sleeve. Used by professional orthodontists/dentists in clinical settings to provide temporary fixed anchorage for orthodontic appliances. Output is a stable anchor point facilitating tooth movement. Removed upon completion of treatment. Benefits include simplified orthodontic mechanics and temporary, removable anchorage.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including mechanical testing (pull-out, torsion, torque) per ISO 19023:2018 and ASTM F543-17, bending tests, biocompatibility (ISO 10993-5 cytotoxicity testing), and sterilization validation (ISO 11137-1/2/3) to SAL 10^-6.
Technological Characteristics
Material: Ti6Al4V (ASTM F136, EN ISO 5832-3). Design: Cylindrical, self-tapping/self-drilling, octagonal head with internal thread. Dimensions: 1.7mm/2.3mm diameter, 8-14mm length. Sterilization: Validated per ISO 11137. Standards: ISO 7405, ISO 10993-5, ISO 19023:2018, ASTM F543-17.
Indications for Use
Indicated for adolescents >12 years and adults requiring orthodontic tooth movement; provides fixed anchorage for orthodontic appliances. Contraindicated for palatal expansion or as a prosthodontic/dental implant component.
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.
Predicate Devices
- Ortho Easy Pin (K110275)
Reference Devices
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 19, 2026
Bernhard Förster GmbH (Bernhard Foerster Ltd.)
% Juan Tezak
Consultant
Compliance 4 Devices, Ltd.
118 Prive Cir
Delray Beach, Florida 33445
Re: K260268
Trade/Device Name: OrthoEasy Pal; OrthoEasy Pal Long Neck
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: OAT
Dated: April 17, 2026
Received: April 17, 2026
Dear Juan Tezak:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260268 - Juan Tezak
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K260268 - Juan Tezak
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260268 | |
| Device Name OrthoEasy Pal; OrthoEasy Pal Long Neck | |
| Indications for Use (Describe) FORESTADENT OrthoEasy® anchorage screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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Bernhard Förster GmbH (Bernhard Foerster Ltd.)
# 510(K) Summary K260268
I) Preparation Date
May 19th 2026
II) Applicant
Submitter: Bernhard Förster GmbH (Bernhard Foerster Ltd.)
Address: Westliche Karl-Friederich-Strass 151 75172 Pforzheim, Germany
Telephone: +49 7231 459-16
Contact: Mr Stefan Förster
E-Mail: regulatory@forestadent.com
III) Device
Trade Name: OrthoEasy Pal; Ortho easy Pal Long Neck
Common Name: Endosseous dental implant
Classification Name: Implant, Endosseous, Orthodontic
Regulation Number: 872.3640
Product Code: OAT
IV) Predicate Device
510(k) K110275
Applicant: Bernhard Förster GmbH (Bernhard Foerster Ltd.)
Trade Name: Ortho Easy Pin
Classification Name: Implant, Endosseous, Orthodontic
Regulation Number: 872.3640
Product Code: OAT
Reference Devices
510(k) K110392
Applicant: PSM Lomas
Trade Name: BENEFIT Screw
Classification Name: Implant, Endosseous, Orthodontic
Regulation Number: 872.3640
Product Code: OAT
510(k) K202691
Applicant: Craniofacial Technologies
Trade Name: Ortholock Anchorage Devices
Classification Name: Implant, Endosseous, Orthodontic
Regulation Number: 872.3640
Product Code: OAT
V) Device Description
OrthoEasy® Pal and OrthoEasy® Pal Long Neck orthodontic implants are screws made of the high-quality metal alloy titanium 6-aluminium 4-vanadium (Ti6Al4V (Titanium Grade 5, ASTM F136, EN ISO 5832-3)). The implant body is cylindrical and has a sharp apex in conical shape. The thread of the implant is self-tapping and self-drilling which makes it a non-surgical orthodontic implant. The implant head is octagonal that ensures precise torque transfer during insertion. All products include a sleeve between the thread and the functional head to protect soft tissue.
VI) Intended Use/Indication for Use
VII) FORESTADENT OrthoEasy® anchorage screw is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only.
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The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component.
VIII) Comparison of Technological Characteristics
| | Bernhard Foerster GmbHOrtho Easy Pin | Bernhard Foerster GmbH Ortho Easy Pal | Comparison Result |
| --- | --- | --- | --- |
| FDA Product Code | OAT | OAT | Same |
| K Number | K110275 | K260268 | N/A |
| FDA Device Classification Name | Implant, Endosseous | Implant Endosseous | Same |
| 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. | FORESTADENT OrthoEasy® anchorage screw is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component. | Similar The age range for which it can be used is specified, and it is clarified that the term "Pal" in the name does not refer to use in the palatal region. None of this affects the substantial equivalence of the use of both devices. |
| Target Population | Adolescents greater than 12 years of age and adults that need of teeth alignment correction. | Adolescents greater than 12 years of age and adults that need of teeth alignment correction. | Same |
| Location of use (hospital, home, ambulance, etc.) | Use only for professional dentists or orthodontics. | Use only for professional dentists or orthodontics. | Same |
| Design | Diameter 1.7mm length ranges from 6 - 12 mm | Diameter 1.7mm, 2.3 mm length ranges from 8 - 14 mm | Different |
| Head Design | Cross-shaped slot | Internal Thread | Different |
| Performance | Self-trapping/self-drilling screws | Self-trapping/self-drilling screws | Same |
| Standard met | ISO 7405 | ISO 7405 | Same |
| Materials | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | Same |
| Biocompatibility | Titanium alloy in medical grade according ASTM F 136 is accepted for endosseous implants. | Cytotoxicity test as per ISO 10993-5 was performed to determine the pull-out, torsion, and torque of the screw in accordance with ISO 19023:2018, Dentistry - Orthodontic anchor screws; and ASTM F543-17, Standard Specification and Test | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Mechanical safety | Tensile strength of material according to ASTM F 136 diameter 1,7mm, fracture-proof during implantation. See also material test reports comparing torque in different materials. | Mechanical testing was performed to determine the pull-out, torsion, and torque of the screw in accordance with ISO 19023:2018, Dentistry - Orthodontic anchor screws; and ASTM F543-17, Standard Specification and Test | Same |
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# Head equivalence
| | PSM Lomas - BENEFIT Screw | Bernhard Foerster GmbH Ortho Easy Pal and Ortho Easy Pal Long Neck | Comparison Result |
| --- | --- | --- | --- |
| FDA Product Code | OAT | OAT | Same |
| K Number | K110392 | K260268 | N/A |
| FDA Device Classification Name | Implant, Endosseous | Implant Endosseous | Same |
| Intended use | The PSM LOMAS / BENEFIT Screws are 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. Screws are intended for single use only. | FORESTADENT OrthoEasy® anchorage screw is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component. | Similar The clarification of the term Pal in the name does not affect the substantial equivalence in the use of both devices. |
| Indication for use | See intended use. | See intended use. | Same |
| Target Population | Patients in need of teeth alignment correction. | Patients in need of teeth alignment correction. | Same |
| Location of use (hospital, home, ambulance, etc.) | Use only for professional dentists or orthodontics. | Use only for professional dentists or orthodontics. | Same |
| Design | | | Similar Both designs are similar, differing only in how they attach to the insertion tool. The subject device features a hexagon design, while the predicate features a quadrant. Mechanical testing conducted on the subject device confirmed that its design functions exactly as intended. |
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Placement location
| | Ortholock Anchorage Devices Craniofacial Technologies | Bernhard Foerster GmbH Ortho Easy Pal and Ortho Easy Pal Long Neck | Comparison Result |
| --- | --- | --- | --- |
| FDA Product Code | OAT | OAT | Same |
| K Number | K202691 | K260268 | N/A |
| FDA Device Classification Name | Implant, Endosseous | Implant Endosseous | Same |
| Intended use | The Ortholock Anchorage Devices are 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. Screws are intended for single use only. | FORESTADENT OrthoEasy® anchorage screw is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component. | Similar The clarification of the term Pal in the name does not affect the substantial equivalence in the use of both devices. |
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| Target Population | Patients in need of teeth alignment correction. | Patients in need of teeth alignment correction. | Same |
| --- | --- | --- | --- |
| Design | | | Different Both designs are similar, differing in how the prosthetic abutments are attached. The subject device features a titanium screw, whereas the abutments on the predicate device thread into its head. Mechanical testing conducted on the subject device confirmed that its design functions exactly as intended. |
| Measures | Diameter 1.8mm Threaded Body: 7.4mm Smooth Neck: 2.2mm and 4.2mm Head: 1.9mm Overall Length: 11.5mm and 13.5mm | Diameter 1.7mm, 2.3 mm Length ranges from 8 - 14 mm | Similar The dimensions are similar. Mechanical testing conducted on the subject device confirmed that its design functions exactly as intended, despite these dimensional differences. |
| Head Design | Externally Threaded, Head for the attachment of orthodontic appliances | Octagon with Internal Thread | Different (See the design section in this table) |
| Performance | Self-trapping/self-drilling screws | Self-trapping/self-drilling screws | Same |
| Standard met | ISO 7405 | ISO 7405 | Same |
| Materials | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | Same |
| Surface Treatment | Anodized | Anodized | Same |
| Biocompatibility | Titanium alloy in medical grade according ASTM F 136 is accepted for endosseous implants. | Cytotoxicity test as per ISO 10993-5 was perform showing non cytotoxic effect | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Placement locations | Suitable locations for Ortholock placement include the paramedian or midsagittal region of the hard palate and the anterior palate. Do not place the Ortholock Anchorage Device screws in the sutures of people with developing bone or sutures that are not completely fused. | Multiple locations in the oral cavity included palatal region. Do not place the Ortholock Anchorage Device screws in the sutures of people with developing bone or sutures that are not completely fused. | Same |
# (X) Summary of Non-Clinical Testing
The following performance data were provided to support the determination of substantial equivalence.
- Mechanical testing was performed to determine the pull-out, torsion, and torque of the screw in
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accordance with ISO 19023:2018, Dentistry – Orthodontic anchor screws; and ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Anchor screw.
- Bending test for a comparative flexural strength test.
- Biological assessment has been performed according to ISO 10993-1:2018, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” and to the FDA Guidance document, “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process’, Guidance for Industry and Food and Drug Administration Staff”, for the subject devices. Cytotoxicity testing according to ISO 10993-5 Biological Evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and no cytotoxicity was observed.
- Sterilization validation testing has been performed in accordance with ISO11137-1, ISO 11137-2 and ISO 11137-3. The sterilization procedure is validated to a Sterility Assurance Level (SAL) of 10-6. No microbial growth was observed.
X) Summary of Clinical Testing
No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.
XI) Conclusion
The results obtained demonstrate that the system's performance and stability are substantially equivalent to the predicate devices.
