K Number

Device Name

Cristaline Aligners Z FLX

Manufacturer

Cristaline Aligners GmbH

Date Cleared

2024-12-19

(87 days)

Product Code

NXC

Regulation Number

872.5470

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K232653

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a process involving digital scans, treatment planning software, 3D printing, and thermoforming, but does not mention AI or ML in the device description, intended use, or performance studies. The treatment planning is explicitly stated to be based on the dental health professional's plan and commercially available software, not an AI/ML algorithm.

Therapeutic

Yes
The device is indicated for the treatment of tooth malocclusions, which is a medical condition, and it achieves this treatment by sequentially positioning teeth through continuous force.

Diagnostic

The device is an aligner used for treating tooth malocclusions, not for diagnosing medical conditions. It is a therapeutic device that sequentially positions teeth.

SaMD (Software as a Medical Device)

The device description clearly states that the device is comprised of "a series of clear, thin, thermoformed removable aligner trays" which are physical, manufactured components, not software. While software is used in the design process, the final device is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The Cristaline Aligners are physical devices used to apply force to teeth to correct malocclusions. They are used directly on the patient's teeth, not for analyzing specimens outside the body.
Intended Use: The intended use is for the treatment of tooth malocclusions, which is a physical correction, not a diagnostic test.
Input: While a digital scan of the teeth is used for design, this is not a biological specimen being analyzed for diagnostic purposes.

Therefore, the Cristaline Aligners fall under the category of a medical device used for treatment, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Cristaline Aligners Z 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.

Product codes

NXC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital file (scan) of the patient's teeth

Anatomical Site

teeth

Indicated Patient Age Range

patients with permanent dentition (i.e. all second molars)

Intended User / Care Setting

dental health professional (dentist/orthodontist)

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)

SAFETY TESTING
Testing of the aligner material has been conducted according to ISO 10993, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management system, was performed 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 manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans. Final reports of the testing of aligners fabricated with the thermoplastic material was part of the 510(k) package.
In vivo Animal and Human Clinical performance testing are not required for this device category.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K232653

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

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.

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

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

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 1-5
75181 Pforzheim, Germany
Contact Person:	Dr. Boris Simnovski
Email:	dr.simanovoski@gmail.com
Date Prepared:	November 13, 2024
DEVICE Trade
Name:	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
PRIMARY
PREDICATE:	K232653, Blue Sky Plan Software, Blue Sky Bio Aligner Z and
Blue Sky Bio Z FLX; Blue Sky Bio, LLC
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.
MECHANISM OF
ACTION	Each aligner in the set is used for the specified period of time,
usually 1-2 weeks, to exert gentle force to achieve progressive
realignment of the teeth until the final correction has been
achieved. The daily treatment time is approximately 22 hours,
or except during eating, based on the clinician's prescribed
treatment plan.
The aligner trays are held in place by pressure and can be
removed by the patients at any time.
SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS	The thermoplastic materials used for the manufacture of the
aligners are identical to the material used for making the
Predicate device aligner Z FLX. The treatment planning
software system used is the Predicate Blue Sky Plan software.
INDICATIONS FOR
USE STATEMENT	Cristaline Aligners Z 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,
sequentially positions teeth by way of continuous force.
SAFETY TESTING	Testing of the aligner material has been conducted according to
ISO 10993, Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management system, was
performed 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 manufacturing
process to ensure the accuracy of the final aligners compared
to the initial digital scans. Final reports of the testing of aligners
fabricated with the thermoplastic material was part of the 510(k)
package.
In vivo Animal and Human Clinical performance testing are not
required for this device category.
COMPARISON TO
THE PREDICATE
DEVICE	The Cristaline Aligners Z FLX devices have the same intended
use as the predicate device. The thermoplastic polymer
materials are the same as the Predicate and digital treatment
planning involves use of the Predicate's commercially available
software The processes for fabrication of the clear aligners,
while proprietary to each manufacturer, makes use of similar,
industry-standard processes using similar machines. Any
differences in the specific manufacturing processes do not raise
new questions of safety and effectiveness.
SUBSTANTIAL
EQUIVALENCE
CONCLUSION	The information and data provided in this 510(k) establish that
the Cristaline Aligners Z FLX devices are substantially
equivalent to the Predicate Blue Sky Bio device in the intended
use, design, principle of operation, technology (same treatment
planning software as the Predicate), and thermoplastic material
(same as aligner Z FLX of the Predicate device). See the
following SE Comparison table.
	Proposed Device	Predicate #1	SE Comparison
510(k) Number
Device Name	K242892
Cristaline Aligners Z FLX	K232653
Blue Sky Plan Software, Blue	N/A
		Sky Bio Aligner Z and Blue Sky
Bio Z FLX
Manufacturer	Cristaline Aligners GmbH	Blue Sky Bio, LLC	N/A
Classification
Regulation and
Name
Product Code
Class	21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2	21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2	Same
Indications for
Use	Cristaline Aligners Z 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.	Blue Sky Bio Aligner Z and Blue
Sky Bio Aligner Z 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.	Same for the Z FLX
Aligner.
Mode of Action	The removable appliance
applies continuous gentle forces
on teeth according to the plan
prescribed by the doctor.	The removable appliance
applies continuous gentle forces
on teeth according to the plan
prescribed by the doctor.	No differences
Description of
Use	Each removable preformed
plastic tray, prescribed by the
Dr, is worn by the patient usually
for 1-2 weeks, prior to using the
next sequential aligner tray
according to Dr's direction.	Each removable preformed
plastic tray, prescribed by the Dr,
is worn by the patient usually for
a couple weeks, prior to using the
next sequential aligner tray
according to Dr's direction.	No differences
Material	Thermoplastic co-polyester
polyurethane composite.	For Z FLX aligner: thermoplastic
co-polyester polyurethane
composite	No differences
Manufacturing
Process	Forming of plastic sheets on SD
printed dental models designed
with use of the treatment
planning software	Forming of plastic sheets on SD
printed dental models designed
with use of the treatment
planning software	Manufacturing
processes used are
standard in the field
and similar to
predicate's.
Software	Commercially available
treatment planning software is
used - same as Predicate	Included in 510(k)	Same software is used
Prescription
Use	Rx	Rx	Both are Rx
Biocompatibility	Testing to meet requirements for
Category C	Testing to meet requirements for
Category C	Relied on the same
testing performed by
thermoplastic material
manufacturer.

Substantial Equivalence Comparison Table

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

| Process
Validation | Validation to determine fit and
form of manufactured aligners. | Similar testing
performed. |

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