The Krystal Klear Aligners System is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align teeth over a period of several months. The aligners are completely removeable by the patient and may be discontinued at any time.

Device Description

The Krystal Klear device is fabricated of clear, thin, thermoformed copolyester plastic in a sequential series to progressively reposition teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

AI/ML Overview

The Krystal Klear Aligners System's acceptance criteria and the study proving it meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria	Reported Device Performance
Fit of the aligner against the treatment plan	As determined by a dental health professional	Acceptable results observed during verification and validation testing, showing capability of performing to stated intended use and specification requirements.
Process consistency	From the treatment plan file to 3D printed mold to final aligner, measured against internal acceptance criteria derived by considering all sources of variation.	Acceptable results observed during verification and validation testing, showing capability of performing to stated intended use and specification requirements.
Density	Met ASTM Method D1505	Met acceptance criteria.
Flexural Modulus	Met ASTM Method D790	Met acceptance criteria.
Flexural Strength	Met ASTM Method D790	Met acceptance criteria.
Tensile Strength	Met ASTM Method D882	Met acceptance criteria.
Tensile Modulus of Elasticity	Met ASTM Method D882	Met acceptance criteria.
Cytotoxicity	Compliant with US FDA Docket Number FDA-2013-D-0350 and ISO 10993-1, non-cytotoxic	Met the requirements of the study protocols and is considered non-cytotoxic.
Sensitization	Compliant with US FDA Docket Number FDA-2013-D-0350 and ISO 10993-1, non-sensitizing	Met the requirements of the study protocols and is considered non-sensitizing.
Irritation	Compliant with US FDA Docket Number FDA-2013-D-0350 and ISO 10993-1, not an intracutaneous irritant	Met the requirements of the study protocols and is not an intracutaneous irritant.
Software Safety and Effectiveness	Software testing performed to verify safety and effectiveness for areas of moderate concern (ordering and treatment planning).	Software testing has been performed to verify the safety and effectiveness of the Krystal Klear Aligner System, which supports a substantial equivalence decision.

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

The document does not explicitly state a specific sample size for a "test set" in the context of a clinical trial or a machine learning evaluation. The performance testing section describes "bench testing" which was performed to ensure accuracy and consistency. This likely refers to in-house engineering and quality control tests on manufactured aligners and processes, rather than a clinical dataset for performance evaluation against a diagnostic algorithm.

The data provenance for these bench tests is internal to the manufacturer ("internal acceptance criteria derived by considering all sources of variation"). There is no mention of country of origin for the data or whether it was retrospective or prospective.

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

The document mentions that the "Fit of the aligner against the treatment plan" was "as determined by dental health professional". It does not specify the number of experts, their specific qualifications (e.g., years of experience, specialization), or how ground truth was established for the "test set."

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

No adjudication method is mentioned for the test set.

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

The document does not describe an MRMC comparative effectiveness study or any study involving human readers or AI assistance. The Krystal Klear Aligner System is a physical medical device (aligners) for orthodontic treatment, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is not an algorithm for standalone performance. The "Software Consideration" section refers to software used in the ordering and treatment planning process, implying human oversight and input, rather than a standalone algorithm with diagnostic capabilities.

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

For the physical attributes (Density, Flexural Modulus, etc.), the ground truth was based on ASTM standards and achieving "acceptance criteria" defined by these standardized methods.

For the "Fit of the aligner against the treatment plan" and "Process consistency," the ground truth was based on "pre-established specifications and acceptance criteria" and likely involves expert assessment by dental health professionals in the context of verification and validation testing.

For biocompatibility, the ground truth was based on standardized biological evaluation tests (cytotoxicity, sensitization, irritation) according to ISO 10993-1 guidance, with results being "non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant."

8. The sample size for the training set:

The document does not mention a "training set" or a machine learning model that would require one. The product is a physical orthodontic device manufactured through a process that includes software for treatment planning but does not describe the use of a machine learning model that would be "trained."

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

As no training set is mentioned or implied for a machine learning model, this question is not applicable.

Summary

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December 19, 2019

Shatkin F.I.R.S.T. LLC Kimberly Wiesmore Controller 2495 Kensington Avenue Amherst, New York 14226

Re: K182388

Trade/Device Name: Krystal Klear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 18, 2019 Received: November 19, 2019

Dear Kimberly Wiesmore:

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 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) K182388

Device Name Krystal Klear Aligners System

Indications for Use (Describe)

The Krystal Klear Aligners System is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.

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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510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21CFR 807.92.

Submitter:	Shatkin F.I.R.ST. LLC2494 Kensington AvenueAmherst, NY 14226Not Currently FDA Registered
Primary Contact:	Kimberley Wiesmore, CFOPhone: 716.839.2959 x 149kwiesmore@shatkinfirst.com
Secondary Contact:	Todd Shatkin, DDSPhone: 716.839.2959
Date Prepared:	26 August 2018 (Original)10 November 2019 (Revised)
Proprietary Trade Name:	Krystal Klear Aligner System
Device Name:	Sequential Aligner
Common Name:	Clear Braces / Aligners
Classification Name:	Orthodontic Plastic Bracket
Regulation Number:	852.5470
Product Code:	NXC
Classification Panel:	Dental Products Panel 76
Classification:	Medical Device, Class II

Predicate Devices:

Clear Image Aligners, Specialty Appliance Works, K071970 (Primary Predicate) Clear Correct, Clear Correct Inc., K082556 (Reference Device) Invisalign, Align Technology, K981095 (Reference Device)

Device Description:

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Indications for Use:

Technological Characteristics:

Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves teeth to a desired end-state is the technological principle for both the subject and predicate devices. A comparison between technological characteristics of the Krystal Klear Aligner System and that of legally marketed predicate devices has been performed. The results of this comparison demonstrate that the design, technology, materials, and composition of the Krystal Klear Aligner System are substantially equivalent to the predicate devices.

A dental health care professional (e.g. orthodontist or dentist), prescribes the Krystal Klear Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. The molds and prescription are created by Krystal Klear. Utilizing standard dental software used for tooth alignment, Masterpieces (MAP) then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, MAP produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1 below.

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Mechanism of Action:

The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic 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.

Performance Testing:

Bench testing was performed to ensure the accuracy of the final product carried through the entire process from the initial scan through treatment planning and manufacturing of the model to the final thermoformed aligner. Functional characteristics tested and the standard by which they were tested include the following, all pre-established specifications and acceptance criteria:

Fit of the aligner against the treatment plan as determined by dental health . professional
Process consistency from the treatment plan file to 3D printed mold to final . aligner was measured against internal acceptance criteria derived by considering all sources of variation

The acceptable results observed during the verification and validation testing that has been conducted on these devices has shown that they are capable of performing to their stated intended use and specification requirements.

Additional physical attributes tested, and the standard by which they were tested are below, which met acceptance criteria:

Attribute	ASTM Method
Density	D1505
Flexural Modulus	D790
Flexural Strength	D790
Tensile Strength	D882
Tensile Modulus ofElasticity	D882

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Further testing was not performed given there is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of safety and effectiveness.

Biocompatibility Testing:

The biological evaluation for the device was conducted in accordance with the US FDA Docket Number FDA-2013-D-0350, "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process – Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:

. Cytotoxicity
Sensitization ●
Irritation ●

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant. The results of the studies further support the determination of substantial equivalence.

Software Consideration

There are two areas in the Krystal Klear Aligner System process where software is used; they are the ordering process and treatment planning. The software usage in these areas is considered of moderate concern. Software testing has been performed to verify the safety and effectiveness of the Krystal Klear Aligner System, which supports a substantial equivalence decision.

Substantial Equivalence Comparison:

The following table compares the Krystal Klear Aligner System to the predicate devices, Clear Image Aligners (primary predicate), and Clear Correct (reference device) & the Align System (reference device), with respect to intended use, technological characteristics, and principles of operation.

The aligner has the same patient contact, similar materials, and the same manufacturing processes as the legally marketed device on the market. As the material is slightly different, biocompatibility testing was performed to verify safety and effectiveness for the Krystal Klear Aligner system.

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Table 1. Predicate Device Information Comparison

	KrystalKlear(SubmissionDevice)	Clear ImageAligners(Primary Predicate)	Clear Correct(Reference Device)	Invisalign/AlignSystem(Reference Device)
Feature	(SubmissionDevice)	(Primary Predicate)	(Reference Device)	(Reference Device)
510(k) Number	K182388	K071970	K082556	K981095
ClassificationNumber & ProductCode	852.5470NXC	852.5470NXC	852.5470NXC	852.5470NXC
Indications for Use	The Krystal KlearSystem is intended tocorrect minordiscrepancies in thealignment ofmaloccluded teeth onpatients withpermanent dentition(second molars) bymoving the teeth witha progressive seriesof thermoformedplastic aligners,fabricated in stagesto gradually alignteeth over a period ofseveral months. Thealigners arecompletely removableby the patient andmay be discontinuedat any time.	The Clear Image TMAligners System isintended to correctminor discrepanciesin the alignment ofmaloccluded anteriorteeth on patients withpermanent dentition(second molars) bymoving the teeth witha progressive seriesof clear thin,thermoformed plasticaligners, fabricated instages to graduallyalign teeth over aperiod of severalmonths. The alignersare completelyremovable by thepatient and may bediscontinued at anytime.	The ClearCorrectSystem is indicatedfor the treatment oftooth malocclusion inpatients withpermanent dentition(i.e. all secondmolars). TheClearCorrect Systempositions teeth byway of continuousgentle force.	The Align System isindicated for thetreatment of toothmalocclusion inpatients withpermanent dentition(i.e. all secondmolars). The AlignSystem positionsteeth by way ofcontinuous gentleforce.
Mode of Action	Alignment of teeth bysequential use ofpreformed plastictrays.	Alignment of teeth bysequential use ofpreformed plastictrays.	Alignment of teeth bysequential use ofpreformed plastictrays.	Alignment of teeth bysequential use ofpreformed plastictrays.
Material	ThermoformedCopolyester	ThermoformedPolycarbonate	ThermoformedPolycarbonate	ThermoformedPolycarbonate
OTC or Rx	Rx	Rx	Rx	Rx

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Substantial Equivalence Conclusion:

The conclusion drawn from the data included in this submission demonstrates that the Krystal Klear Aligner System is as safe, effective, and substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials, and biocompatibility.

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.