(143 days)
No
The description details a workflow using standard dental software for model creation and design, followed by 3D printing and thermoforming. There is no mention of AI or ML algorithms being used for treatment planning, model generation, or any other part of the process. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this.
Yes
The device is indicated for use in the alignment of permanent teeth through orthodontic treatment and guides teeth to their final position by way of continuous gentle forces, which are characteristics of a therapeutic device.
No
The device is an orthodontic aligner used for the physical alignment of teeth, not for diagnosing a condition or disease.
No
The device description clearly states that the Arkligners device is fabricated of clear thin thermoformed plastic and is a physical product. While software is used in the design and manufacturing process, the final medical device is a physical aligner.
Based on the provided information, the Arkligners device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Arkligners Function: Arkligners are physical devices (clear aligners) used to mechanically move teeth for orthodontic treatment. They are fabricated based on patient scans and a treatment plan, but they do not analyze biological specimens or provide diagnostic information from those specimens.
- Intended Use: The intended use is "alignment of permanent teeth... through orthodontic treatment of misalignment and malocclusion." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the fabrication process and materials, all related to creating a physical appliance for tooth movement.
- Input: The input is "Scans," which are digital representations of the teeth, not biological specimens.
- Anatomical Site: The anatomical site is "Permanent teeth," which are the target of the mechanical force, not the source of a diagnostic specimen.
In summary, Arkligners are a medical device used for treatment (orthodontics), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Clinicians scan a patient, export the views needed for the patient model, and sends these scans to Arklign Laboratories. They import them into 3Shape Dental Manager 2020 to create a patient model. The patient model is imported into 3Shape Ortho System 2021 Clear Aligner Studio to design the models to make clear aligners for the treatment plan the clinician has ordered. This treatment plan (with models needed to make aligners for whichever treatment phases are being ordered) is then exported and sent to the clinician along with the original patient model file for them to approve. Then Arklign Laboratories exports the approved models needed to make the specific aligners ordered to Formlabs Form 2 3D printer running Formlabs PreForm 3.12.0. The aligner is thermoformed over the printed model. Every aligner is checked for fit on the printed patient model before sending to the clinician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scans
Anatomical Site
Teeth / dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, Dental Health Professional / 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)
Arklign conducted manufacturing validation with 3Shape Ortho System 2021 Clear Aligner Studio being used to fabricate the models used to produce aligners and based upon patient scans representing three specific clinical scenarios. Clinicians working with Arklign determined the treatment plan. The software used to create the original digital patient model was 3Shape Dental Manager 2020. This model was exported to the 3Shape Ortho System 2021 Clear Aligner Studio for creation of the models to form aligners over. Once the models to form aligners were designed then the designs were exported to Formlabs PreForm 3.12.0 being run on a Formlabs Form 2 3D printer and printed using Formlabs Draft Resin V2.
Arkligners were created over the models by using a Scheu-Dental BioStar thermoforming machine. Settings for this thermoforming machine for Essix Ace 1mm thick disks are found in the instructions for use accompanying the Essix Ace disks. Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
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August 12, 2022
Arklign Laboratories % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K220835
Trade/Device Name: Arkligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 1, 2022 Received: June 13, 2022
Dear Angela Blackwell:
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 mediation-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.
Michael E. Adjodha, M.ChE. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K220835
Device Name Arkligners
Indications for Use (Describe)
Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.
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)
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3
K220835
Arkligners 510K Summary March 10, 2022
Name and Address: Arklign Laboratories 2526 Qume Dr Suite 15 San Jose, CA 95131 Contact Person: Rex Ho Email: rho@arklign.com Telephone: (800) 361 1659 Website: www.arklign.com
Name of device: Arkligners Common name: Sequential aligners Classification Name: Orthodontic Plastic Bracket CFR: 21 CFR 872.5470 Primary Product Code: NXC Class: Il Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description: The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Clinicians scan a patient, export the views needed for the patient model, and sends these scans to Arklign Laboratories. They import them into 3Shape Dental Manager 2020 to create a patient model. The patient model is imported into 3Shape Ortho System 2021 Clear Aligner Studio to design the models to make clear aligners for the treatment plan the clinician has ordered. This treatment plan (with models needed to make aligners for whichever treatment phases are being ordered) is then exported and sent to the clinician along with the original patient model file for them to approve. Then Arklign Laboratories exports the approved models needed to make the specific aligners ordered to Formlabs Form 2 3D printer running Formlabs PreForm 3.12.0. The aligner is thermoformed over the printed model. Every aligner is checked for fit on the printed patient model before sending to the clinician.
4
Indications for Use: Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.
Technological Characteristics:
Treatment of tooth malocclusions via a series of intraoral plastic appliances designed to provide forces for incremental movement of targeted teeth to a desired final position is the technological principle for both the subject device and the predicate device.
Mechanism of Action:
The mechanism of action is similar to the predicate devices. Orthodontic targeted tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
Testing Summary: The material used for the Arkligners is Essix Ace 1mm thick disks. This same Dentsply Esssix Ace was cleared In K062828 and the same material is used in the predicate device BRIUS Clear Aligners. Literature studies show this material has sufficient wear properties for this indication. Literature studies used the same thickness of Essix Ace (1mm).
A biocompatibility assessment of Essix Ace was evaluated during its 510k clearance. A cytotoxicity test was conducted to show the contact of the Essix Ace disk with the model made from Formlabs Draft Resin V2 did not change the non-cytotoxic nature of the Essix Ace.
Arklign conducted manufacturing validation with 3Shape Ortho System 2021 Clear Aligner Studio being used to fabricate the models used to produce aligners and based upon patient scans representing three specific clinical scenarios. Clinicians working with Arklign determined the treatment plan. The software used to create the original digital patient model was 3Shape Dental Manager 2020. This model was exported to the 3Shape Ortho System 2021 Clear Aligner Studio for creation of the models to form aligners over. Once the models to form aligners were designed then the designs were exported to Formlabs PreForm 3.12.0 being run on a Formlabs Form 2 3D printer and printed using Formlabs Draft Resin V2.
Arkligners were created over the models by using a Scheu-Dental BioStar thermoforming machine. Settings for this thermoforming machine for Essix Ace 1mm thick disks are found in the instructions for use accompanying the Essix Ace disks. Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit.
Predicate Device: K202792 BRIUS Clear Aligners
Reference Devices: K062828 Dentsply Essix
5
Substantial Equivalence:
| Device | Arkligners | BRIUS Clear
Aligners
K202792 | Dentsply Essix
K062828 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR
872.5470 | 21 CFR
872.5470 | unclassified |
| Device
Classification
Name/Device
Common
Name | Orthodontic
Plastic
Bracket | Orthodontic
Plastic
Bracket | Prescription
mouthguard/Mouthguard
and Aligner Materials |
| Product Code | NXC | NXC | MQC |
| Classification | II | II | unclassified |
| Indications
for use | Arkligners
are indicated
for the
treatment of
tooth
malocclusion
in patients
with
permanent
dentition (i.e.
all second
molars). The
aligners
position
teeth by way
of
continuous
gentle force. | BRIUS Clear
Aligners are
indicated for
use in the
alignment of
permanent
teeth (i.e. all
second
molars)
through
orthodontic
treatment of
misalignment
and
malocclusion.
The aligners
guide teeth to
their final
position by
way
of continuous
gentle forces. | MOUTHGUARD AND
ALIGNER MATERIALS are
indicated for the
fabrication of orthodontic
and dental appliances
such as aligners, bite
planes, mouthguards,
nightguards, snoring
appliances, splints,
retainers, repositioners,
and temporary bridges. |
| Mode of
action | Orthodontic
tooth
movement
occurs
through
forces
applied | Orthodontic
tooth
movement
occurs
through
forces applied | |
| | by the
appliance to
the
dentition as
each tooth
follows the
programmed
displacement
based on a
doctor's
prescription. | by the
appliance to
the
dentition as
each tooth
follows the
programmed
displacement
based on a
doctor's
prescription. | |
| Material | Dentsply
Essix
Thickness of
1mm | Dentsply Essix
Thickness of
$\frac{3}{4}$ , 7/8 and 1
mm | Dentsply Essix Ace
Thicknesses of $\frac{3}{4}$ , 7/8 and
1 mm |
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Conclusion: Based on materials, technological characteristics, mechanism of action, indications for use and the results of non-clinical performance testing, Arkligners are substantially equivalent to BRIUS Clear Aligners K202792.