Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.

Device Description

Cristaline Aligners Z FLX are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are manufactured using a biocompatible thermoplastic sheet composed of a composite of co-polyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Cristaline. Based on the dental health professional's treatment plan, Cristaline develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are formed on the molds. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Cristaline Aligners Z FLX." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria as might be seen for novel devices.

Therefore, the document does not contain information regarding traditional acceptance criteria or a study that proves the device meets such criteria in the way a clinical trial would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device.

Here's an breakdown of the relevant information provided, specifically addressing your numbered points, and highlighting what is not applicable in this context:

A table of acceptance criteria and the reported device performance:
As this is a 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics in the way a clinical study would define them (e.g., sensitivity, specificity, accuracy against a gold standard). The "acceptance criteria" here are met by demonstrating substantial equivalence to a predicate device.

The table on pages 4 and 6 titled "SUBSTANTIAL EQUIVALENCE CONCLUSION" and "Substantial Equivalence Comparison Table" serves to compare the new device to the predicate device across various characteristics.

Implicit "Acceptance Criteria" and "Reported Performance" (as per 510(k) standards):

Characteristic	Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison)
Indications for Use	Same as predicate device (Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX).	"Same for the Z FLX Aligner."
Mode of Action	No differences from predicate device (removable appliance applies continuous gentle forces on teeth).	"No differences."
Description of Use	No differences from predicate device (removable preformed plastic tray worn by patient for 1-2 weeks, prior to next sequential aligner tray).	"No differences."
Material	Same as predicate device (Blue Sky Bio Aligner Z FLX - Thermoplastic co-polyester polyurethane composite).	"No differences."
Manufacturing Process	Processes used are standard in the field and similar to predicate's (forming plastic sheets on 3D printed dental models designed with treatment planning software). Does not raise new questions of safety/effectiveness.	"Manufacturing processes used are standard in the field and similar to predicate's." Any differences do not raise new questions of safety and effectiveness.
Software	Same commercially available treatment planning software as predicate.	"Same software is used."
Prescription Use	Both are prescription use (Rx).	"Both are Rx."
Biocompatibility	Testing to meet requirements for Category C, relying on the same testing performed by the thermoplastic material manufacturer as the predicate.	"Relied on the same testing performed by thermoplastic material manufacturer." (Passed In vitro Cytotoxicity, Oral Mucosal Irritation, Skin Sensitization per ISO 10993).
Process Validation	Validation to determine fit and form of manufactured aligners, similar to predicate testing.	"Similar testing performed." (Bench testing performed to validate manufacturing process accuracy against digital scans).

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This document focuses on demonstrating substantial equivalence through comparison of materials, design, and manufacturing processes, rather than a clinical "test set" in the traditional sense.
- Test Set Sample Size: Not applicable. The "testing" involved biocompatibility and bench testing.
- Data Provenance:
  - Biocompatibility testing: Performed by a GLP-certified contract research laboratory. No specific country of origin is mentioned for the data, but the submitter (Cristaline Aligners GmbH) is based in Pforzheim, Germany.
  - Bench testing: Performed by the submitter. No specific country of origin is mentioned for the data.
  - The basis for substantial equivalence is comparison to the predicate device (Blue Sky Plan Software, Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX; Blue Sky Bio, LLC).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth as established by experts for a specific performance metric (like diagnostic accuracy) is not relevant to this 510(k) submission, which relies on engineering and biological safety testing, and comparison to a predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There was no clinical "test set" requiring adjudication.
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:
Not applicable. This device is an orthodontic aligner, not an AI diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an orthodontic aligner. While its manufacturing involves "commercially available treatment planning software," the filing describes the aligner itself, not the software as a standalone AI algorithm for diagnostic purposes. The software is part of the manufacturing process to create the physical aligners.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of clinical performance ground truth. The "ground truth" for this submission revolves around:
- Biocompatibility standards (ISO 10993).
- Engineering validation of manufacturing accuracy against digital scans.
- The established safety and effectiveness of the legally marketed predicate device.
The sample size for the training set:
Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.
How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/ML device with a training set.

Summary

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December 19, 2024

Cristaline Aligners GmbH % Patsy Trisler Regulatory Consultant Trisler Consulting (dba) 306 Turnberry Court Lebanon, Indiana 46052

Re: K242892

Trade/Device Name: Cristaline Aligners Z FLX Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: September 18, 2024 Received: September 23, 2024

Dear Patsy Trisler:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 -S

Michael E. Adjodha, MChE, RAC, CQIA 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

Submission Number (if known)

K242892

Device Name

Cristaline Aligners Z FLX

Indications for Use (Describe)

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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Submitter:	Cristaline Aligners Z FLX
Cristaline Aligners GmbH	K242892	Traditional Premarket Notification 510(k)
SUBMITTER Name:	Cristaline Aligners GmbH
Address:	Hanauer Strasse 1-575181 Pforzheim, Germany
Contact Person:	Dr. Boris Simnovski
Email:	dr.simanovoski@gmail.com
Date Prepared:	November 13, 2024
DEVICE TradeName:	Cristaline Aligners Z FLX
Common Name:	Aligner, Sequential (Clear Braces)
Classification Name	Orthodontic Plastic Bracket
Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Review Panel	Dental
PRIMARYPREDICATE:	K232653, Blue Sky Plan Software, Blue Sky Bio Aligner Z andBlue Sky Bio Z FLX; Blue Sky Bio, LLC
DEVICEDESCRIPTION	Cristaline Aligners Z FLX are comprised of a series of clear,thin, thermoformed removable aligner trays that are designed tocorrect tooth malocclusions without the use of conventionalwire and bracket orthodontic technology. They aremanufactured using a biocompatible thermoplastic sheetcomposed of a composite of co-polyester and polyurethane.They are provided non-sterile and are customized for eachpatient according to the dental clinician's prescription.The dental health professional (dentist/orthodontist) provides adigital file (scan) of the patient's teeth to Cristaline. Based onthe dental health professional's treatment plan, Cristalinedevelops a digital plan using commercially available treatmentplanning software. Upon approval by the dental healthprofessional, molds are created with 3D-printing technology andthe clear aligners are formed on the molds.The finished, customized aligners are provided to the dentalhealth care professional who provides them to the patient,confirming fit and design.
MECHANISM OFACTION	Each aligner in the set is used for the specified period of time,usually 1-2 weeks, to exert gentle force to achieve progressiverealignment of the teeth until the final correction has beenachieved. The daily treatment time is approximately 22 hours,or except during eating, based on the clinician's prescribedtreatment plan.The aligner trays are held in place by pressure and can beremoved by the patients at any time.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	The thermoplastic materials used for the manufacture of thealigners are identical to the material used for making thePredicate device aligner Z FLX. The treatment planningsoftware system used is the Predicate Blue Sky Plan software.
INDICATIONS FORUSE STATEMENT	Cristaline Aligners Z FLX are series of clear, lightweight, plasticappliances, indicated for treatment of tooth malocclusions inpatients with permanent dentition (i.e. all second molars).Utilizing a series of incremental tooth movements,sequentially positions teeth by way of continuous force.
SAFETY TESTING	Testing of the aligner material has been conducted according toISO 10993, Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk management system, wasperformed by a GLP-certified contract research laboratory:• In vitro Cytotoxicity (Part 5)• Oral Mucosal Irritation (Part 10)• Skin Sensitization (Part 10)
OTHER TESTING	Bench testing was performed to validate the manufacturingprocess to ensure the accuracy of the final aligners comparedto the initial digital scans. Final reports of the testing of alignersfabricated with the thermoplastic material was part of the 510(k)package.In vivo Animal and Human Clinical performance testing are notrequired for this device category.
COMPARISON TOTHE PREDICATEDEVICE	The Cristaline Aligners Z FLX devices have the same intendeduse as the predicate device. The thermoplastic polymermaterials are the same as the Predicate and digital treatmentplanning involves use of the Predicate's commercially availablesoftware The processes for fabrication of the clear aligners,while proprietary to each manufacturer, makes use of similar,industry-standard processes using similar machines. Anydifferences in the specific manufacturing processes do not raisenew questions of safety and effectiveness.
SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this 510(k) establish thatthe Cristaline Aligners Z FLX devices are substantiallyequivalent to the Predicate Blue Sky Bio device in the intendeduse, design, principle of operation, technology (same treatmentplanning software as the Predicate), and thermoplastic material(same as aligner Z FLX of the Predicate device). See thefollowing SE Comparison table.
	Proposed Device	Predicate #1	SE Comparison
510(k) NumberDevice Name	K242892Cristaline Aligners Z FLX	K232653Blue Sky Plan Software, Blue	N/A
		Sky Bio Aligner Z and Blue SkyBio Z FLX
Manufacturer	Cristaline Aligners GmbH	Blue Sky Bio, LLC	N/A
ClassificationRegulation andNameProduct CodeClass	21 CFR 872.5470Orthodontic Plastic BracketNXC2	21 CFR 872.5470Orthodontic Plastic BracketNXC2	Same
Indications forUse	Cristaline Aligners Z FLX areseries of clear, lightweight,plastic appliances, indicated fortreatment of tooth malocclusionsin patients with permanentdentition (i.e. all second molars).Utilizing a series of incrementaltooth movements, it sequentiallypositions teeth by way ofcontinuous force.	Blue Sky Bio Aligner Z and BlueSky Bio Aligner Z FLX are seriesof clear, lightweight, plasticappliances, indicated fortreatment of tooth malocclusionsin patients with permanentdentition (i.e. all second molars).Utilizing a series of incrementaltooth movements, it sequentiallypositions teeth by way ofcontinuous force.	Same for the Z FLXAligner.
Mode of Action	The removable applianceapplies continuous gentle forceson teeth according to the planprescribed by the doctor.	The removable applianceapplies continuous gentle forceson teeth according to the planprescribed by the doctor.	No differences
Description ofUse	Each removable preformedplastic tray, prescribed by theDr, is worn by the patient usuallyfor 1-2 weeks, prior to using thenext sequential aligner trayaccording to Dr's direction.	Each removable preformedplastic tray, prescribed by the Dr,is worn by the patient usually fora couple weeks, prior to using thenext sequential aligner trayaccording to Dr's direction.	No differences
Material	Thermoplastic co-polyesterpolyurethane composite.	For Z FLX aligner: thermoplasticco-polyester polyurethanecomposite	No differences
ManufacturingProcess	Forming of plastic sheets on SDprinted dental models designedwith use of the treatmentplanning software	Forming of plastic sheets on SDprinted dental models designedwith use of the treatmentplanning software	Manufacturingprocesses used arestandard in the fieldand similar topredicate's.
Software	Commercially availabletreatment planning software isused - same as Predicate	Included in 510(k)	Same software is used
PrescriptionUse	Rx	Rx	Both are Rx
Biocompatibility	Testing to meet requirements forCategory C	Testing to meet requirements forCategory C	Relied on the sametesting performed bythermoplastic materialmanufacturer.

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Substantial Equivalence Comparison Table

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Submitter:		Cristaline Aligners Z FLX
Cristaline Aligners GmbH	K242892	Traditional Premarket Notification 510(k)

ProcessValidation	Validation to determine fit andform of manufactured aligners.	Similar testingperformed.
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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.