(137 days)
The Precision Align aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Precision Aligners positions teeth by way of continuous gentle force.
The Precision Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence. A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. 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 profession'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. Precision Align Co. produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
The provided text describes the regulatory clearance of a medical device (Precision Align Aligners) and outlines non-clinical performance data. However, it explicitly states that no clinical performance data was deemed necessary to support the device's clearance. Therefore, a study proving the device meets acceptance criteria regarding clinical performance (like diagnostic accuracy, efficacy, or improvement over human readers) does not exist within this document.
The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technological characteristics.
Here’s the information based on the provided text, with an emphasis on the absence of clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study was performed, the acceptance criteria are not for clinical performance but for manufacturing accuracy, biocompatibility, and material properties.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| Dimensional Accuracy (Manufacturing) | Translational measurement within 0.150mm (150 microns) of target input; No statistical difference in values measured; All aligners passed initial fitness evaluation. |
| Final Aligner Fitness | All aligners in the study passed and were deemed an "excellent fit" by a trained physician. |
| Material Biocompatibility (Patient-Contacting) | Passed: |
| - In vitro cytotoxicity (ISO 10993-5) | Confirmed |
| - Skin Irritation (ISO 10993-10) | Confirmed |
| - Sensitization (ISO 10993-10) | Confirmed |
| Finished Device Biocompatibility (Cytotoxicity) | Passed: Minimal Essential Media (MEM) Elution (ISO 10993-5) |
| Material Physical Properties | Tested and compliant with standards (ASTM D638, D570 for Tensile Strength, Elongation, Modulus, Water Absorption). |
2. Sample Size for Test Set and Data Provenance
As no clinical study was conducted, there is no "test set" in the context of clinical performance or diagnostic accuracy.
For the internal manufacturing validation:
- Sample Size: Not explicitly stated, but "all the aligners included in the study" passed for initial fitness evaluation.
- Data Provenance: Internal validation conducted by Precision Align LLC.
For biocompatibility:
- Material testing was conducted by "the material manufacture."
- Finished device cytotoxicity testing was performed on "the final manufactured Precision Align Aligners."
- Sample Size: Not specified for these tests.
- Data Provenance: Not specified beyond being conducted by the material manufacturer or Precision Align LLC.
3. Number of Experts and Qualifications for Ground Truth for Test Set
Not applicable, as no clinical study or diagnostic accuracy study with a "test set" requiring expert ground truth was performed.
For the internal manufacturing validation:
- "Expert" for fitness evaluation: A "trained physician." No further details on qualifications or number of physicians.
- Ground Truth: The subjective assessment of "excellent fit" by the trained physician.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as the document explicitly states: "there was no clinical testing necessary to support this device." The device is an orthodontic aligner, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical orthodontic aligner, not an algorithm, and no clinical performance study was conducted.
7. Type of Ground Truth Used
For the non-clinical tests:
- Dimensional Accuracy: Instrumental measurements compared against predefined tolerance (0.150mm).
- Aligner Fit: Subjective assessment of "excellent fit" by a trained physician.
- Biocompatibility: Results of specific biological tests (e.g., cytotoxicity, irritation, sensitization) evaluated against ISO 10993 standards.
- Material Properties: Measurements from standard ASTM tests.
8. Sample Size for the Training Set
Not applicable. This document does not describe the development or training of an AI algorithm, but rather the clearance of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI algorithm training set is described.
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January 15, 2022
Precision Align LLC. % Na Zhang Project Manager evo820, LLC 1 Bay Street Rancho Mission Viejo, California 92694
Re: K212772
Trade/Device Name: Precision Align Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 06, 2021 Received: December 09, 2021
Dear Na Zhang:
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
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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,
For 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
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Indications for Use
510(k) Number (if known) K212772
Device Name Precision Align
Indications for Use (Describe)
The Precision Align aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Precision Aligners positions teeth by way of continuous gentle force.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section V. 510(k) Summary
SUBMITTER
| Date Prepared: | |
|---|---|
| Submitter: | Precision Align LLC. |
| 1825 NE 45th Street Suite AFort Lauderdale, Florida 33308United States of America | |
| Official Contact: | Chris FreemanMRGMTel:954-837-8367Email: drchris@precisionalignco.com |
DEVICE
| Trade/Proprietary Name: | Precision Align |
|---|---|
| Common Name: | Aligners, Sequential |
| Classification Name : | Orthodontic Plastic Bracket |
| Classification Regulations: | 21CFR 872.5470 |
| Product Code: | NXC |
| Device Classification: | Class II |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PRIDICATE DEVICE
| Predicate Device: | K211010 | Illusion Aligners | Laximi Dental Exports PvtLtd. |
|---|---|---|---|
| Reference Device: | K191838 | ClearForm Aligners | Motor City Lab Works |
| Reference Devicefor Software | K200772 | ULab Systems uDesignSoftware | ULab Systems, Inc. |
DEVICE DESCRIPTION
The Precision Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.
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A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. 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 profession'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. Precision Align Co. produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
INDICATIONS FOR USE
The Precision Align Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Precision Align Aligners position teeth by way of continuous gentle force.
COMPARISON OF TECHNOLOGICAL WITH THE PREDICATE DEVICE
The subject device is substantial equivalent in intended use and technological characteristics to predicate devices shown above. Below is a summary table comparing the subjective device with the primary predicate and an additional reference predicate device.
| Features | Submission Device | Predicate Device | Reference PredicateDevice |
|---|---|---|---|
| Manufacture | Precision Align LLC. | Laximi Dental ExportsPvt Ltd. | Motor City Dental Lab |
| Trade Name | Precision Align | Illusion Aligners | ClearfForm Aligners |
| 510(k)Number | K212772 | K211010 | K191838 |
| RegulationNumber | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Classifications | Class II | Class II | Class II |
| Product Code | NXC | NXC | NXC |
| Indications forUse | The Precision AlignAligners are indicatedfor the treatment oftooth malocclusion inpatients withpermanent dentition(i.e., all secondmolars). The PrecisionAlign Alignersposition teeth by wayof continuous gentleforce. | The Illusion Alignersindicated for use in thealignment of permanentteeth(i.e. all secondmolars) throughorthodontic treatment ofmisalignment andmalocclusion. | ClearForm Aligners areindicated for thealignment of teeth inpatients with permanentdentition (i.e. all secondmolars) duringorthodontic treatment ofmalocclusions. Thealigners position teeth byway of continuous gentleforces |
| Mode ofActions | Orthodontic toothmovement occursthrough forces appliedby the appliance to thedentition as each toothfollows theprogrammeddisplacement based ona doctor's prescription. | Alignment of teeth byapplication ofcontinuous gentle force,by sequential use ofpreformed plastics trays | Orthodontic movementoccurs throughcontinuous gentle forcesapplied to the dentitionas each tooth follows theprogrammeddisplacement based on adoctor's prescription. |
| Material | PETG, thermoplastic | PETG (Polyethyleneterephthalate glycol)material | Essix thermoplastic |
| Biocompatible | Yes | Yes | Yes |
| Software | The standard orthodental software uses ascan of toothimpression or a digitalscan to generate theimage of a final,treated state and theninterprets a series ofimages that representintermediate teethstates. Once the dentalpractitioner approvesthe treatment plan, thesoftware converts thefiles to produce theseries of patientspecific aligners. | The scanned data(digital CAD/CAMmodels or patientmodels) are importedinto specialized dentalsoftware for treatmentplanning. LaximiDental Exports Pvt Ltd,Inc. utilizes a softwareapplication to plant thetreatment by creating aseries of sequentialmodels that graduallyposition the teeth intotheir final desiredposition. The treatmentplan is sent to thedoctor for approval.Upon approval , a 3Dprinter is used to create | Standard dental softwarefor tooth alignment usesdigital scan (untreatedstate) to generate theimage of a final,provisional treated stateand then interprets aseries of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject orrequest modifications tothe set-up prior toapproving it for alignerfabrication. Once thedental practitionerapproves the treatmentplan, the software |
| the molds needed foreach treatment step toprovide the surfacearound which thealigner is thermoformed | converts the files toproduce the series of 3Dmodels used to producethermoformed aligners | ||
| ManufactureMethod | Thermoforming | Thermoforming | Thermoforming |
| Rx or OTC | Rx | Rx | Rx |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Design | Image: aligner | Image: aligner | Image: aligner |
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Differences compare Precision Aligners to Predicate Device
| Precision Aligners | S& E Effect | Illusion Aligners |
|---|---|---|
| Precision Align LLC. uses ULabSystems K200772 | No Effect. ULab systems K20072 isFDA 510(k) cleared software, theuse /manufacturing process hasbeen validated by Precision AlignLLC. | Laxmi Dental Exports Pvt. Ltd, Inc.uses 3Shape Software K180941 andK152086 |
| Precision Align LLC. providedbiocompatibility testing results(cytotoxicity, Skin irritation andSensitization) of the thermoplasticPETG material according toISO10993. Precision Align LLC.also performed biocompatibilitytesting(cytotoxicity) of the finisheddevice(Precision Aligner) accordingto ISO10993 | No Effect. Additional cytotoxicitytesting of the finished deviceprovide more insurance of thesafety and effectiveness of usingthe subject device. | Laxmi Dental Exports Pvt. Ltd, Inc.performed biocompatibilitytesting(cytotoxicity, Skin irritationand Sensitization) of thethermoplastic PETG materialaccording to ISO10993 |
The intended use of the Precision Align aligner is the primary predicate device. They are both intended for correcting dental malocclusion patients with permanent dentition. It has similar technological characteristics and fabricated by a similar manufacturing process to the predicate device. There are minor difference comparing Precision Aligner with the predicate device Illusion Aligner which do not affect substantial equivalence or safety and effectiveness. Therefore, the Precision Aligner is considered to be substantially equivalent to the predicate device based on a comparison of intended use and technological characteristics.
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Non-Clinical PERFORMANCE DATA
Non-clinical testing have been conducted to verify that the Precision Align Aligner meets all design specification which supports the conclusion that it's substantially equivalent (SE) to the predicate device.
Software used for treatment planning and creation of models/mold for Precision Align Aligner is manufactured by ULab Systems, Inc. It is a 510(k) clearance (K200772) software under product code PNN for intended use.
An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Precision Aligner. The critical aspects of the manufacturing process were assessed for accuracy. The final aligner fitness was evaluated according to the in-house fitness acceptance criteria.
Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. There were no statistical difference in the difference in the values measured from any of the groups. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation by a trained physician demonstrate all the aligners including in the study passed and were deemed an excellent fit .
The biocompatibility evaluation determined that Precision Align Aligner and the predicate devices are composed of the same material, fabricated by the similar manufacturing processes, and has identical method of use, which can conclude that Precision Align Aligners are biocompatible for their intended use.
Biocompatibility testing for the aligner material, the only patient contacting material, was conducted by the material manufacture in accordance with International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- Test for in vitro cytotoxicity : Elution Method ISO10993-5
- Skin Irritation Test in New Zealand White Rabbits ISO10993-10 .
- Sensitization Test in Guinea Pigs(Guinea Pig maximization Test) ISO10993-10 .
Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Precision Align Aligners .
-
Test for in vitro cytotoxicity : Minimal Essential Media (MEM) Elution ISO10993-5 .
Non-Clinical physical properties of the device material have been tested by the material manufacture complying with the following standard -
Tensile Strength at Break(MPa) ASTM D638
-
. Tensile Stress at Yield (MPa)
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| • Elongation at Break (%) | ASTM D638 |
|---|---|
| • Elongation at Yield (%) | ASTM D638 |
| • Tensile Modulus (MPa) | ASTM D638 |
| • Water Absorption at 23°C, 24h | ASTM D570 |
CLINICAL PERFORMANCE DATA
The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Precision aligners have equivalent indication and method of use to its primary and reference predicate devices, there was no clinical testing necessary to support this device.
CONCLUSIONS
The subject device has very similar technological characteristics (i.e. design, function, principle of operation, materials, biocompatibility and sterilization) to the predicate device . The intended use and indications for use of the subject device are the same as the predicate device.
In conclusions, the device is substantially equivalent based on a comparison of intended use, and technological characteristics and the device is considered to be safe and effective for its intended use.
§ 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.