The Concinnity Aligners™ is a custom clear aligner system. They are a series of doctor (orthodontist or dentist) prescribed clear plastic removable aligners that are used as alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.

The Concinnity Aligners™ comes in two forms: a polyurethane-based material used to treat malocclusion in heavy bruxers, and a second form made from cycloaliphatic co-polyester polyurethane used in for all other patients. The polyurethane material is identical to the predicate device's material, and the cvcloaliphatic co-polyester and polyurethane materials are used in the reference device.

The manufacturing of Concinnity™ Aligners begins with the clinician prescribing aligners to treat a patient's malocclusion. The decision to use clear aligner-based treatment is made by the clinician. In addition to the prescription the clinician also provides Drake Precision Dental Laboratory (DPDL) with a model of the patient's dentition. The clinician can generate a digital file by scanning the patient's mouth directly using Intraoral scanner (IOS) software, such as 3Shape Trios or iTero software. A mold of the patient's dentition is obtained using traditional impression material or by converting the mold to a stone model.

Impressions are taken by the dental clinician and submitted to Drake Labs along with the physician's prescription. All incoming impressions are logged and tracked under the DPDL QMS system. If DPDL receives a digital file it is tracked through its QMS system without any modifications. If DPDL receives a stone model from the information is entered and tracked as per QMS. The stone model is scanned using a digital scanner and converted into a digital file. Upon receipt of traditional impression molds, they are converted to stone models which can be scanned and digitized.

The digital files are sent to a third party design firm which develops the treatment plan. The third-party design firm utilizes the digital files and the prescription from the clinician to create a customized treatment plan that is reviewed and approved by the clinician. The customized plan generates a series of *.stl CAD files for building models that allow fabrication of aligners that gently move the teeth in small increments. The third party uses the 3Shape Clear Aligner Studio (K180941) to develop the treatment plan. The treatment plan is sent to the prescribing clinician for approval before it is sent back to DPDL.

Once DPDL receives these *.stl CAD files of the treatment plan the CAD unit in DPDL receives the documents, updates the QMS documentation and manufacturing begins. The DPDL manufacturing unit generates sequential 3D printed models replicating the clinician approved treatment plan. The sequential models are 3D printed and are used to generate clear thermoplastic aligners.

The aligners are cut to fit dentition, the cleaned and polished to remove rough edges. The sequential aligners are the packaged and labeled. Quality assurance ensures that the correct aligners are being shipped to the prescribing physician. The final product is released and shipped to the prescribing clinician who is responsible for ensuring the patient's safe use of the device.

The Concinnity™ Aligners are manufactured using thermoplastic polymers used by the predicate and reference devices. Manufacturing, processing, labeling, and shipping of the aligners are performed under strict quality control procedures that ensures Concinnity Aligners™ is manufactured under the QMS.

Drake Labs sends the aligners to the doctor who delivers them to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.

AI/ML Overview

The provided text describes the Concinnity Aligners™ and a study conducted to demonstrate their performance. However, much of the requested information regarding acceptance criteria and performance study details (e.g., specific metrics for acceptance, sample sizes for test and training sets, expert qualifications, and detailed statistical results) is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and manufacturing fit validation, rather than a clinical trial with human-in-the-loop or standalone AI performance.

Therefore, many sections of your request will be answered with "Not explicitly stated in the document" or derived from the available information.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility:
- Cytotoxicity (ISO 10993-5)	Passed
- Sensitization (ISO 10993-10)	Passed
- Intracutaneous Reactivity (ISO 10993-10)	Passed
- Oral Mucosal Irritation (ISO 10993-10)	Passed
- Genotoxicity (ISO 10993-3)	Passed
- Skin Irritation (ISO 10993-10)	Passed
- Subchronic Systemic Toxicity (ISO 10993-11)	Passed
Manufacturing Fit Validation (Bench Performance):
- Accuracy and predictability of printed models (digital vs. 3D)	"The differences in distances measured were within statistically established tolerance limits." (Specific tolerances/metrics not provided).
- Aligner fit, function, and adaptability (clinician evaluation)	All four test cases received a "Grade A, passing all pre-determined evaluation criteria." No manufacturing inconsistencies could be found. (Specific criteria not provided).
Substantial Equivalence to Predicate Devices	Concluded to be substantially equivalent based on identical intended use, similar materials and manufacturing processes, identical clinical use, anatomical location, and frequency/duration of exposure. This is the primary "acceptance criterion" for 510(k) clearance. A detailed comparison table is provided in the document demonstrating concordance across key attributes with the predicate (Custom Clear Aligners System, K173785) and reference (Ormco Spark Aligner System, K182826) devices.

Study Details

2. Sample size used for the test set and data provenance

Sample Size for Test Set: For the "manufacturing fit validation study," four complete orthodontic cases were evaluated.
Data Provenance: The document does not explicitly state the country of origin for these four cases. It implies they are real orthodontic cases from clinicians providing prescriptions and dental impressions to Drake Precision Dental Laboratory. The study was conducted by Drake Precision Dental Laboratory (DPDL). The study is retrospective in the sense that existing case data (impressions/digital scans) for the chosen cases would have been used for the manufacturing validation.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Number of Experts: "A licensed clinician then evaluated the clear aligner's quality for fit, function, and adaptability." This suggests at least one licensed clinician.
Qualifications of Experts: Assumed to be a "licensed clinician." Specific qualifications (e.g., orthodontist, years of experience) are not explicitly stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: None explicitly described. The evaluation was performed by "a licensed clinician." There is no mention of multiple reviewers or an adjudication process for the manufacturing fit validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for AI-assisted diagnostic devices. The Concinnity Aligners™ are a physical medical device (orthodontic aligners), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The core device (Concinnity Aligners™) is not an algorithm, but a manufactured product. The software used for treatment planning (3Shape Clear Aligner Studio, K180941) is a third-party design firm's tool. The submission is for the aligners themselves, not independent software performance. Therefore, a "standalone algorithm performance" study is not applicable in the context of this device. The closest equivalent would be the assessment of the digital model files' accuracy, which was part of the manufacturing fit validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the "manufacturing fit validation," the ground truth or reference points were:
- The digital model files (presumably approved by the clinician, representing the intended treatment plan).
- The "pre-determined evaluation criteria" used by the licensed clinician for assesssing fit, function, and adaptability. These criteria are not detailed in the document.
- It is not based on pathology or clinical outcomes data, but on the physical accuracy of the manufactured aligners against the digital design and their subjective fit assessment by a clinician.

8. The sample size for the training set

Sample Size for Training Set: The document describes the device, its manufacturing process, and a manufacturing fit validation study. There is no mention of a "training set" as this is not a machine learning/AI device that requires a training phase.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" or AI component described in the submission that would require establishing ground truth for training.

Summary

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November 9, 2020

Drake Precision Dental Laboratory Inc % Srinagesh Koushik Managing Partner BDRA Consulting LLC 1 Clearwater Court Damascus, Maryland 20872

Re: K200005

Trade/Device Name: Concinnity Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: October 1, 2020 Received: October 2, 2020

Dear Srinagesh Koushik:

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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200005

Device Name Concinnity Aligners™

Indications for Use (Describe)

The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K200005 510k Summary

510k Owner:	Drake Precision Dental Laboratory INC
510k Owner Address:	Drake Precision Dental Laboratory INC8510 Crown Crescent Ct.Charlotte, NC, 28227
Contact:	Robert SavageVice President / Chief Financial Officer
Phone:	704-845-2401 Extension 1106
Email:	bsavage@drakelab.com
Submission Correspondent:	Shree Koushik Ph.D. RACBDRA Consulting LLC1 Clearwater Court, Damascus, MD 20872
Phone:	301-922-7231
Email:	shree@bdraqa.com
Date Prepared:	November 2, 2020
Device Trade Name:	Concinnity Aligners™
Classification Name:	Orthodontic Plastic Bracket
Common Name:	Sequential Aligner
Classification Number:	21 CFR 872.5470
Product Code:	NXC
Classification:	2
Predicate Device:	K173785, Custom Clear Aligners SystemClearance date 03/13/2019
Reference Device:	K182826, Ormco Spark Aligner SystemClearance Date: 10/11/2018

Intended Use / Indications for use:

The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

Device Description:

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lmpressions are taken by the dental clinician and submitted to Drake Labs along with the physician's prescription. All incoming impressions are logged and tracked under the DPDL QMS system. If DPDL receives a digital file it is tracked through its QMS system without any modifications. If DPDL receives a stone model from the information is entered and tracked as per QMS. The stone model is scanned using a digital scanner and converted into a digital file. Upon receipt of traditional impression molds, they are converted to stone models which can be scanned and digitized.

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Operating Principle:

Each progressive aligner is intended to be worn for 2 weeks for 22 hours per day (removal only for eating and oral hygiene). Gentle force is applied (by the aligner) to achieve progressive realignment of the teeth until the teeth are aligned as per treatment plan. Similar to predicates and traditional braces the treatment plan proceeds over time under clinician supervision.

Biocompatibility testing:

The following biocompatible studies were performed on the thermoplastic polymers used to manufacture Concinnity Aligners:

Biocompatibility
Number	Test	Standard	Results
1	Cytotoxicity	ISO 10993-5	Passed
2	Sensitization	ISO 10993-10	Passed
3	Intracutaneousreactivity	ISO 10993-10	Passed
4	Oral mucosal Irritation	ISO 10993-10	Passed
5	Genotoxicity	ISO 10993-3	Passed
6	Skin irritation	ISO 10993-10	Passed
7	Sub chronic systemictoxicity	ISO 10993-11	Passed

Biocompatibility evaluation conducted determined that the Concinnity Aligners™ are biocompatible for their intended use.

Bench Performance Testing:

Bay Materials LLC, the manufacturer of the thermoplastic aligner materials, have conducted extensive physical properties testing. DPDL conducted a manufacturing fit validation study using both material types.

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Briefly, four complete orthodontic cases have been evaluated at several different intervals in the manufacturing process of the Concinnity Aligners™. The integrity of the printed models from the digital files was assessed at several stage intervals for accuracy and predictability of the printed models.

The digital model files were measured using the digital measurement tool within the 3shape software. The printed digital models, as well as the aligners, were measured using digital hand calipers. A licensed clinician then evaluated the clear aligner's quality for fit, function, and adaptability to the software treatment design models and the printed models.

The manufacturing fit validation process included the following steps: first, four different orthodontic cases that could be treated using Concinnity Aligners™ were selected. Next, after receiving the prescription and dental impression from the prescribing clinician, the subjects were documented as per the DPDL quality management system. Then, the digital files of the patient's impressions were sent to a third-party design firm. The design firm designed the treatment plan and obtained prescribing clinicians' approval. Finally, upon receipt of the treatment design files, DPDL 3D printed dental models of the first, middle, and last stages for each of the four cases. Aligners from both thermoplastic aligners were cast for the first, middle and last stages for the four cases.

The differences in distances between digital files, 3D models, and aligners were calculated and evaluated. The manufacturing fit validation study demonstrated the differences in distance measured were within statistically established tolerance limits. Furthermore, the aligner fit clinician evaluation showed that the aligners manufactured at each stage demonstrated that all test cases received a Grade A, passing all pre-determined evaluation criteria. No manufacturing inconsistencies could be found.

This study and the data included have demonstrated that Concinnity Aligners can be manufactured as intended.

Animal or Human testing:

Concinnity Aligners™ are composed of identical material components as the predicate devices, using similar manufacturing processes. They have the same intended use, including the same intended anatomical location and frequency and duration of use. Additionally, the material manufacturer conducted physical properties testing and provided the reports to FDA. Therefore, animal and human testing was not determined to be necessary.

Substantial Equivalence:

The Concinnity Aligner's intended use is identical to the predicate and reference device. They all are all made of the same materials, using similar manufacturing processes, and have identical clinical use. They also are used in the same intended anatomical location and have the same frequency and duration of exposure. Drake Precision Dental Laboratory concludes that

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Concinnity Aligners™ is substantially equivalent to the predicate devices.

Substantial Equivalence Table:

Trade Name:	Custom Clear AlignerSystem	K182826	Concinnity Aligners™	Material	Thinthermoformedpolyurethane	Thermoplastic polyurethane -polyester composite resin	Identical to thepredicate orreferencedevice
	Primary Predicate	Reference Device	Subject Device	Biocompatible	Yes	Yes	Yes
510(k) Number	K173785	K182826		Primary Predicate	Primary Predicate	Reference Device	Subject Device
Manufacturer	Derby Dental Laboratory, Inc.	Sybron Dental Specialties	Drake Precision DentalLaboratory	OTC or Rx	Rx	Rx	Rx
Trade Name:	Custom Clear AlignerSystem	K182826	Concinnity Aligners™	Software Use forordering workflow	Yes	Yes	Yes
RegulationProduct CodeClassificationClassificationName	21 CFR 852.5470NCXClass 2Orthodontic Plastic Bracket	21 CFR 852.5470NCXClass 2Orthodontic Plastic Bracket	21 CFR 852.5470NCXClass 2Orthodontic Plastic Bracket	Trade Name:	Custom Clear AlignerSystem	K182826	Concinnity Aligners™
Intended Use /Indications for use	The Custom Clear AlignerSystem is indicated for use inthe alignment of permanentteeth through the orthodontictreatment of misalignmentand malocclusion.	The Ormco™ Spark™ AlignerSystem is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion in patients withpermanent dentition (i.e., allsecond molars). The Ormco™Spark™ Aligner System positionsteeth by way of continuous gentleforce.	The Concinnity Aligners™ isintended for orthodontictreatment and correction ofmisaligned and maloccludedpermanent teeth (i.e. all secondmolars).	Sterile	No	No	No
Operating Principle	Alignment of teeth byapplication of continuousgentle force, by sequentialuse of preformed plastictrays.	Orthodontic tooth movementoccurs through forces applied bythe appliance to the dentition aseach tooth follows theprogrammed displaStone basedon a doctor's prescription	Each progressive aligner isintended to be worn for 2weeks / 22 hours per day(removal only for eating andoral hygiene), where gentleforce is applied (by thealigner) to achieveprogressive realignment ofthe teeth till the teeth arealigned as per treatmentplan. Similar to predicatesand traditional braces thetreatment plan proceedsovertime under cliniciansupervision.
Method of Use	Each preformed plastic trayis worn by the patient asprescribed by the dentalpractitioner, usually a fewweeks before using thenext sequential aligner tray.	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentition aseach tooth follows theprogrammed displaStonebased on a doctor'sprescription	Each sequentialpreformed plastic tray isworn by the patient as perprescriber instruction.

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Regulation Number and Section

§ 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.