(590 days)
No
The summary describes a mechanical orthodontic anchorage device and does not mention any AI or ML components or functionalities.
No
Explanation: The device is intended to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement, not to directly treat or cure a disease or condition. While it aids in orthodontic treatment, it doesn't directly provide a therapeutic effect.
No
The device is an orthodontic microimplant intended to provide a temporary fixed anchorage point for orthodontic treatment, not to diagnose a condition.
No
The device description clearly states it is an "implantable self-drilling orthodontic microimplant" made from Ti6Al4V, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Ortholock Function: The Ortholock Anchorage Device is an implantable screw used within the body to provide a physical anchorage point for orthodontic appliances. It does not analyze or test any bodily specimens.
The description clearly indicates it's a physical implant for mechanical support during orthodontic treatment, not a diagnostic tool.
N/A
Intended Use / Indications for 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.
Product codes
OAT
Device Description
The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances.
The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.
| Part. No. | Total Length | Neck Length | Diameter | Color |
|---|---|---|---|---|
| OL011 | 11.5mm | 2.2mm | 1.8mm | Green |
| OL013 | 13.5mm | 4.2mm | 1.8mm | Blue |
Orthodontic microimplants are used for the anchorage of orthodontic appliances to treat malpositioned teeth. Ortholock is inserted in the hard palate into each of the two insertion apertures of the appliance accessory with corresponding internal threads for Ortholock's external locking threads. The appliance accessory includes a tube for the attachment of 1.1 mm orthodontic round wire. Ortholock is intended for temporary use during orthodontic treatment. The device is single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hard palate
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing using protocols based on ISO 19023 and ASTM F543-17 for torsional properties, driving torque, axial pullout strength, and self-tapping performance. The test results of these tests demonstrated that similar mechanical performance values could be achieved by the subject and primary predicate device.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Craniofacial Technologies, Inc. % Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 3419 Denny Street Pittsburgh, Pennsylvania 15201
Re: K202691
Trade/Device Name: Ortholock Anchorage Devices Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: March 25, 2022 Received: March 28, 2022
Dear Michael Nilo:
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. 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 located 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.
Andrew I. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202691
Device Name Ortholock Anchorage Devices
Indications for Use (Describe)
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.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
3
510k Summary Ortholock Anchorage Devices Prepared: April 28, 2022
Name and Address: Craniofacial Technologies Inc. 98 Buckskin Rd West Hills, California 91307 Contact Person: Kevin Kaveh Email: kevin@craniofacialtech.com Telephone: (818)-282-6677
Name of device: Ortholock Anchorage Devices Classification Name: orthodontic implants CFR: 21 CFR 872.3640 Primary Product Code: OAT
Device Description:
The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances.
The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.
| Part. No. | Total Length | Neck
Length | Diameter | Color |
|-----------|--------------|----------------|----------|-------|
| OL011 | 11.5mm | 2.2mm | 1.8mm | Green |
| OL013 | 13.5mm | 4.2mm | 1.8mm | Blue |
The following table describes the two versions of Ortholock:
Orthodontic microimplants are used for the anchorage of orthodontic appliances to treat malpositioned teeth. Ortholock is inserted in the hard palate into each of the two insertion apertures of the appliance accessory with corresponding internal threads for Ortholock's external locking threads. The appliance accessory includes a tube for the attachment of 1.1 mm orthodontic round wire. Ortholock is intended for temporary use during orthodontic treatment. The device is single use only.
Indications for 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.
Testing Summary: Ortholock was compared to the primary predicate device in bench testing using protocols based on ISO 19023 and ASTM F543-17 for torsional properties, driving torque, axial pullout
4
strength, and self-tapping performance. The test results of these tests demonstrated that similar mechanical performance values could be achieved by the subject and primary predicate device.
Ortholock Anchorage Device is provided Non-Sterilized by end user). Sterilization by moist heat was validated by ISO 17665-1.
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.
Primary Predicate Device: The C-Type and Special Type Orthodontic Anchor Screws (K063495) Biomaterials Korea
Reference Device:
PSM Medical BENEFIT Screw - (K110392)
Substantial Equivalence:
| | Subject Device | Primary Predicate
Device | Reference Device |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Ortholock Anchorage
Devices
Craniofacial Technologies
(K202691) | The C-Type, CT Type
and Special Type
Orthodontic Anchor
Screws K063495
Biomaterials Korea | PSM Medical BENEFIT Screw
– (K110392) |
| Indications for
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. | Intended for use as a
temporary anchor
for orthodontic
treatment | 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. |
5
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
|---|---|---|---|
| Surface | |||
| Treatment | Anodized | Anodized | Anodized |
| Design | Image: Ortholock screw and blue attachment | Image: Ortholock screw | Image: Ortholock screw and attachment |
| Body Diameter | 1.8mm | 1.8mm | 2.0mm and 2.3mm |
| Head Structure | Externally Threaded | ||
| Head for the attachment | |||
| of orthodontic appliances | Bracket head for the | ||
| attachment of | |||
| orthodontic | |||
| appliances (extra | |||
| long neck also | |||
| facilitates the | |||
| attachment of | |||
| orthodontic | |||
| appliances) | Internally Threaded Head | ||
| for the attachment of | |||
| orthodontic appliances | |||
| Length | Threaded Body: 7.4mm | ||
| Smooth Neck: 2.2mm | |||
| and 4.2mm | |||
| Head: 1.9mm | |||
| Overall Length: 11.5mm | |||
| and 13.5mm | Threaded Body: | ||
| 7mm | |||
| Smooth Neck: 4mm | |||
| and 6mm | |||
| Head: 2.1mm | |||
| Overall Length: | |||
| 13.1mm and | |||
| 15.1mm | Available in threaded | ||
| lengths of 7mm, 9mm, | |||
| 11mm, and 13mm. | |||
| 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. | Multiple locations in the | ||
| oral cavity. | |||
| Non-Sterile | |||
| (Sterilized before | |||
| use) | Yes | Yes | Yes |
| Sterilization | |||
| Validation | |||
| Provided | Yes | Yes | Yes |
| Principles of | |||
| Operation | Orthodontic implants are | ||
| used for the anchorage | |||
| of orthodontic appliances | |||
| to treat malpositioned | |||
| teeth. The head of the | |||
| screw contains an | |||
| external thread for the | |||
| attachment of | |||
| orthodontic appliances | |||
| for temporary use during | |||
| orthodontic treatment. | Orthodontic | ||
| implants are used for | |||
| the anchorage of | |||
| orthodontic | |||
| appliances to treat | |||
| malpositioned teeth. | |||
| The head of the | |||
| microimplant | |||
| contains a slot | |||
| feature for the | |||
| attachment of | |||
| orthodontic | |||
| appliances for | |||
| temporary use | |||
| during orthodontic | |||
| treatment. | Orthodontic implants are | ||
| used for the anchorage of | |||
| orthodontic appliances to | |||
| treat malpositioned teeth. | |||
| The head of the PSM | |||
| Medical Benefit | |||
| microimplant contains an | |||
| internal thread for the | |||
| attachment of orthodontic | |||
| appliances for temporary | |||
| use during orthodontic | |||
| treatment. |
6
Conclusion: Ortholock Anchorage Screws are substantially equivalent to the Biomaterials Korea C-Type, CT Type and Special Type Orthodontic Anchor Screws because they have substantially similar indications, are intended for the same use, are made from the same materials, and have the same principle of operations. They are both sold non-sterilized by the user, both are self-drilling, and have similar testing including sterilization and bench testing. Comparative bench testing shows their mechanical characteristics are similar. Their diameters, lengths, smooth neck lengths, and head sizes are similar. The head design of the subject device is similar to the head design of the reference device-the PSM Medical BENEFIT Screw. In both the proposed device, orthodontic appliances intended for the same use are firmly anchored to the screw head with the use of threads and similar appliance accessories.