(161 days)
Not Found
No
The description mentions "software-generated sequence of intermediate states" based on a "clinician's prescribed treatment plan," but there is no mention of AI, ML, or image processing being used in this generation process. The focus is on the physical properties of the aligners and the manufacturing process validation.
Yes
The device is described as aligning teeth through continuous gentle force to correct malocclusion, which is a therapeutic action.
No
The device is an aligner used for orthodontic treatment to move teeth, not to diagnose a condition.
No
The device description explicitly states that the device is a series of "clear plastic removable aligners," which are physical components, not software. While software is used to generate the sequence of intermediate states, the device itself is the physical aligner trays.
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 for diagnosis, monitoring, or screening.
- Device Function: The Oral Image QuickAligners are a physical device used to apply force to teeth for alignment. They are used on the patient's body, not to analyze specimens from the patient's body.
- Intended Use: The intended use is for the "alignment of teeth" during orthodontic treatment, which is a physical manipulation of the body, not a diagnostic test.
- Input: The input is a mold impression of the teeth, which is used to create the physical aligners, not for diagnostic analysis.
The device description clearly indicates it's a physical appliance for orthodontic treatment, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Oral Image QuickAligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a software-generated sequence of intermediate states.
Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day.
A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Oral Image, Inc produces the aligner trays by thermoforming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient in sequential stages. Additional trays are used sequentially by the patient to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital or traditional mold impression
Anatomical Site
teeth
Indicated Patient Age Range
permanent dentition (i.e. all second molars)
Intended User / Care Setting
dental health professional (e.g. orthodontist or dentist)
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)
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners to an established standard was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
Aligner sheet physical properties testing was conducted and provided for review by the material manufacturer.
Bench testing was performed to validate the manufacturing process. An assessment was performed to validate aligner fit and performance.
Biocompatibility testing for the aligner material, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The results of the tests satisfy the requirements of the study protocols and comply with ISO 10993-1 for the intended use.
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there no clinical testing is required to support Oral Image QuickAligners, as the Indications for Use is equivalent to the Predicate device, which also was not subject to clinical testing. No clinical data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
October 26, 2021
Oral Image, Inc % Chris Brown Manager Aclivi. LLC 3250 Brackley Drive Ann Arbor, Michigan 48105
Re: K211537
Trade/Device Name: QuickAligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 21, 2021 Received: September 27, 2021
Dear Chris Brown:
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.
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
1
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 (OS) 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211537
Device Name Quick Aligners
Indications for Use (Describe)
Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.
| 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."
3
510(k) Summary K211537 Oral Image, Inc QuickAligners 9/21/2021
ADMINISTRATIVE INFORMATION
| Submitter/Manufacturer Name: | Oral Image, Inc |
|---|---|
| 6440 Lusk Blvd | |
| Suite D101 | |
| San Diego, CA 92121 | |
| Telephone: | +1 855-352-5526 |
| Official Contact: | Vinh Lam, CRO |
|---|---|
| Email: | vinh.lam@oralimage.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | QuickAligners |
|---|---|
| Common Name: | Aligners, sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification Regulations: | 21 CFR 872.5470 |
| Device Class: | Class II |
| Product Code: | NXC |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
| Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate device:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K202857 | ClearPath Aligner | ClearPath Orthodontics, Ltd |
| 510(k) | Reference Device Name | Company Name |
DEVICE DESCRIPTION
The Oral Image QuickAligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a softwaregenerated sequence of intermediate states.
Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day.
4
A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Oral Image, Inc produces the aligner trays by thermoforming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient in sequential stages. Additional trays are used sequentially by the patient to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
The technology is the same as that used by the Predicate device, ClearPath Aligner (K202857) and a number of other sequential aligner systems currently being legally marketed.
INDICATIONS FOR USE
Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.
EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is substantially equivalent to the Predicate device with respect to Indications for Use and technological principles. The Comparison table below compares parameters and characteristics of the Subject device and Predicate/reference devices.
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| QuickAligners | ||
| Oral Image, Inc | ClearPath Aligner | |
| ClearPath Orthodontics, Ltd | ||
| K202857 | ||
| Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC |
| Classification | Class II | Class II |
| Indications for Use | Oral Image QuickAligners are indicated for the | |
| alignment of teeth in patients with permanent | ||
| dentition (i.e. all second molars) during orthodontic | ||
| treatment of malocclusion. QuickAligners position | ||
| teeth by way of continuous gentle force. | The ClearPath Aligner is a series of clear, lightweight, | |
| plastic appliances indicated for the correction of dental | ||
| malocclusion in patients with permanent dentition (i.e. all | ||
| second molars). The ClearPath Aligner positions teeth by | ||
| way of continuous gentle force. | ||
| Mode of Action / Use | Based on a clinician's prescribed treatment plan, each | |
| aligner in the set is used for the specified period of | ||
| time to exert gentle force to achieve progressive | ||
| realignment of the teeth until the final correction has | ||
| been achieved. Standard treatment time for each | ||
| aligner tray is 2-3 weeks, worn by patient for 22 hours | ||
| per day. | Based on a clinician's prescribed treatment plan, each | |
| aligner in the set is used for the specified period of time to | ||
| exert gentle force to achieve progressive realignment of | ||
| the teeth until the final correction has been achieved. | ||
| Standard treatment time for each aligner tray is 2-3 | ||
| weeks, worn by patient for 22 hours per day. | ||
| Software used | Yes, for treatment planning and 3D printing of models. | Yes, for treatment planning and 3D printing of models. |
| 3D Software | ||
| Description | It is used for management of 3D scanned orthodontic | |
| models, orthodontic diagnosis by measuring, analyzing, | ||
| inspecting and visualizing 3D scanned orthodontic | ||
| models, virtual planning of orthodontic treatments by | It is used for management of 3D scanned orthodontic | |
| models, orthodontic diagnosis by measuring, analyzing, | ||
| inspecting and visualizing 3D scanned orthodontic models, | ||
| virtual planning of orthodontic treatments by simulating |
Predicate Device Comparison Table
5
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| QuickAligners | ||
| Oral Image, Inc | ClearPath Aligner | |
| ClearPath Orthodontics, Ltd | ||
| K202857 | ||
| simulating tooth movements, and design of | ||
| orthodontic appliances based on 3D scanned | ||
| orthodontic models. | tooth movements, and design of orthodontic appliances | |
| based on 3D scanned orthodontic models. | ||
| Material | Thermoformed plastic | Thermoformed plastic |
| Appliance Application | Removable | Removable |
| Design | Image: Subject Device Design | Image: Predicate Device Design |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Sterile | Non-sterile | Non-sterile |
| Validation Testing | Yes, performed. | Yes, performed. |
The wording of the Indications for Use of the Subject device is highly similar to that of the Predicate device, differing slightly in wording and device name. These differences do not change the intended use of the Subject or Predicate devices to be used in the alignment of teeth during orthodontic treatment of malocclusion and supports a finding of substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS
Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action and use is the same as the Predicate device and supports a determination of substantial equivalence.
The Subject and Predicate devices both use 510(k)-cleared Software in treatment planning process which supports a determination of substantial equivalence. The Reference device software has been validated for use with the Subject device.
The Subject and Predicate devices are both fabricated of a non-sterile, biocompatible thermoplastic material which supports a determination of substantial equivalence.
NON-CLINICAL PERFORMANCE DATA
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners to an established standard was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
Aligner sheet physical properties testing was conducted and provided for review by the material manufacturer.
Bench testing was performed to validate the manufacturing process. An assessment was performed to validate aligner fit and performance.
Biocompatibility testing for the aligner material, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The results of the tests satisfy the requirements of the study protocols and comply with ISO 10993-1 for the intended use.
6
CLINICAL TESTING
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there no clinical testing is required to support Oral Image QuickAligners, as the Indications for Use is equivalent to the Predicate device, which also was not subject to clinical testing. No clinical data is included in this submission.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices are substantially equivalent.
Overall, the Technological Characteristics, Materials, Prescription Use and Non-sterile status of the Subject device are substantially equivalent to the Predicate device. The use of Software to produce the Subject and Predicate devices is substantially equivalent. A manufacturing validation has been done to demonstrate the manufacturing process works as intended. The fit/performance validation has been performed to demonstrate the device and manufacturing process are suitable for intended use.
Overall, the Oral Image QuickAligners are substantially equivalent to the Predicate device.