Blue Sky Plan Software orthodontic module is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts which may be used for sequential aligners, based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment, and at the end of treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

Blue Sky Bio Aligner Z and Blue Sky Bio Aligner Z FLX are series of clear, lightweight, plastic appliances indicated for the 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.

The use of the Blue Sky Plan Software module requires the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

A dental clinician, using a standard personal computer prescribes the orthodontic appliance based on an assessment of the patient's teeth and determines the course of treatment using the Blue Sky Plan Software. The clinician takes molds of the patient's teeth and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate the aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then send the files to the dental lab.

The Blue Sky Bio Aligners (Z and Z FLX) consist of a series of clear plastic aligner trays which are fabricated with the selected thermoplastic material (either a thin polyurethane sheet or a composite of copolyester and polyurethane). Both materials are commercially used for thermoforming customized removable aligners for the intended use.

The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner Z or Z FLX.

The finished aligners are sent to the dental clinician who then provides them to the patient, confirming fit and form. Over a period of time, additional aligner trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental clinician monitors treatment from delivery of the first aligner to the final aligner.

The trays are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Blue Sky Plan Software and Blue Sky Bio Aligner Z/Z FLX. While it describes the device, its intended use, and its substantial equivalence to predicate devices, it does not contain the specific details about acceptance criteria, the full study design, or performance metrics that would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself.

The document does mention:

"Device Testing Laboratory Testing" which states: "Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners. Testing was conducted to characterize device performance characteristics according to ASTM D638. Testing to verify and validate the software has been included in this 510(k) documentation."
"Biocompatibility" testing according to ISO 10993.
"No animal or human testing are required for this product." This is a key statement, indicating that no human clinical study was performed or required for this 510(k) clearance. The clearance is based on substantial equivalence to existing devices, supported by bench testing and software verification/validation.

Therefore, I cannot extract the detailed information requested in your prompt (acceptance criteria with reported performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set details) because this information is not present in the provided FDA 510(k) summary.

The closest I can come to fulfilling your request, based only on the provided text, is to state what was tested at a high level and what was not tested (human clinical performance).

Based on the provided document, the following information can be extracted regarding device testing and acceptance:

The FDA 510(k) summary for the Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX indicates that the clearance was based on demonstrating substantial equivalence to predicate devices, supported by laboratory testing and software verification/validation, rather than a human clinical study with specific performance acceptance criteria against ground truth.

Therefore, many of the specific details requested regarding human studies, expert consensus, and detailed performance metrics are not available in this document, as such studies were explicitly stated as "not required for this product."

Here's what can be gathered directly from the text:

1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The primary acceptance criterion for this 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices, supported by bench testing and software verification/validation.
- Reported Device Performance:
  - Mechanical Properties: Testing was conducted to characterize device performance characteristics according to ASTM D638 (Standard Test Method for Tensile Properties of Plastics) for the clear customized aligners. Specific numerical results are not provided in this summary, only that "Test data were submitted to validate the processes."
  - Biocompatibility: ISO 10993 testing (Parts 3, 5, 10) was performed according to Good Laboratory Practices to ensure the two thermoplastic materials are biocompatible and non-toxic for oral contact use. Results are summarized as "materials shown to be biocompatible and non-toxic." Specific numerical results are not provided.
  - Software Verification/Validation: "Testing to verify and validate the software has been included in this 510(k) documentation." No specific acceptance criteria or performance metrics for the software are detailed in this summary beyond this general statement.
2. Sample size used for the test set and the data provenance:
- Not explicitly stated in the document for the material and software testing.
- Data Provenance: The testing mentioned (ASTM D638, ISO 10993) is laboratory-based (bench testing). No human data or data provenance (country, retrospective/prospective) is applicable, as "No animal or human testing are required for this product."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No human experts were involved in establishing ground truth for a clinical test set, as no human clinical testing was performed or required for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human clinical test set requiring adjudication was used.
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:
- No MRMC study was done. The document explicitly states: "No animal or human testing are required for this product." The software is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design." It is not presented as an AI-assisted diagnostic tool that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed in the summary. While "Testing to verify and validate the software has been included," the specifics of standalone performance metrics (e.g., accuracy of segmentation, treatment simulation) are not provided in this public summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical ground truth. Ground truth for the software's functionality would be defined by engineering specifications and benchmarks against expected computational outputs, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set:
- Not applicable/Not provided. This document does not suggest the use of machine learning models requiring large training sets in the sense of AI. Even if there were internal training sets for any sort of computational model, the size is not disclosed in this summary.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. Same as above. If the software utilizes any internal models, their "ground truth" would be established through engineering principles rather than clinical data.

In summary, the provided document explicitly states that "No animal or human testing are required for this product" for its FDA clearance. Therefore, detailed information about clinical study designs, expert involvement, and performance metrics typically associated with such studies (like MRMC or standalone AI performance) is absent and not relevant to this specific 510(k) submission. The clearance is based on demonstrating substantial equivalence, supported by bench testing of materials and general software verification/validation.

Summary

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April 3, 2024

Blue Sky Bio, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting, dba 306 Turnberry Court Lebanon, Indiana 46052

Re: K232653

Trade/Device Name: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, PNN Dated: August 30, 2023 Received: March 6, 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 (OS) 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.

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-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).

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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

510(k) Number (if known)

K232653

Device Name

Blue Sky Plan Software, and Blue Sky Bio Aligner Z and Blue Sky Bio Aligner 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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510(k) Summary K232653

Submitter Address: 800 Liberty Drive Libertyville, IL 60048

Azickmann@blueskybio.com Email Address:

Contact Person: Dr. Albert Zickmann, VP, Product Development

Date Prepared: March 6, 2024

Device Trade Name:

Blue Sky Plan Software and Blue Sky Bio Aligner Z and Blue Sky Bio Alianer Z FLX

Device Names Requlation Numbers Product Codes Class

Orthodontic Software	Sequential Aligner
21 CFR 872.5470	21 CFR 872.5470
PNN	NXC
2	2

Predicate Device Information

510(k) #, Device Trade name & Manufacturer Device Name Regulation Number Product Code

Reference Devices

510(k) #, Device Trade name & Manufacturer Device Name Regulation Number Product Code

Indications for Use:

Predicate #1 (Primary):	Predicate #2 (Secondary):
K223518iOrtho,Shanghai EA Medical InstrumentsCo., Ltd.	K192596,uLab Systems Dental Aligner Kit;uLab Systems, Inc.
Orthodontic Software	Aligner, Sequential
21 CFR 872.5470	21 CFR 872.5470
PNN	NXC
K180107	K221845,
Blue Sky Bio Aligner; Blue Sky BioLLC	Blue Sky Bio Aligner G & BlueSky Plan Software for Blue SkyBio Aligner G; Blue Sky Bio, LLC
Aligner, Sequential	Orthodontic Software
21 CFR 872.5470	21 CFR 872.5470
NXC	PNN, NXC

Blue Sky Plan Software orthodontic module is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts which may be used for sequential aligner trays and aligners, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment, and at the end of treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

Blue Sky Bio Aligner Z and Blue Sky Bio Aligner Z FLX are series of clear, lightweight, plastic appliances indicated for the treatment

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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.

The use of the Blue Sky Plan Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description: A dental clinician, using a standard personal computer prescribes Summary of the orthodontic appliance based on an assessment of the patient's Technological teeth and determines the course of treatment using the Blue Sky Characteristics. Plan Software. The clinician takes molds of the patient's teeth Material Composition and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL and Mechanism of Action files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate the aligners. Alternatively, the dental clinician may qenerate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then send the files to the dental lab.

The Blue Sky Bio Aligners (Z and Z FLX) consist of a series of clear plastic aligner trays which are fabricated with the selected thermoplastic material (either a thin polyurethane sheet or a composite of copolyester and polyurethane). Both materials are commercially used for thermoforming customized removable aligners for the intended use.

The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner Z or Z FLX.

The finished aligners are sent to the dental clinician who then provides them to the patient, confirming fit and form. Over a period of time, additional aliqner trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental clinician monitors treatment from delivery of the first aligner to the final aligner.

The trays are held in place by pressure and can be removed by the patient at any time.

Device Testing Laboratory Testing

Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners.

Testing was conducted to characterize device performance characteristics according to ASTM D638.

Testing to verify and validate the software has been included in this 510(k) documentation.

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Biocompatibility

ISO 10993 testing, according to Good Laboratory Practices, has been performed to assure the two thermoplastic materials are biocompatible and non-toxic for the oral contact use:

Part 3 (Bacterial Mutagenicity - Ames Assay)

Part 5 (Cytotoxicity Elution - MEM),

Part 10 (Intracutaneous/Intradermal) Reactivity),

Part 10 (Oral Mucosa Irritation)

Animal | Human Testing

No animal or human testing are required for this product.

Comparison to Predicate and Reference Devices:

The similarities in intended use and technological characteristics comparing the subject Blue Sky Plan Software and Blue Sky Bio Z and Z FLX aligners to the Predicates follow:

The software has the same intended use as the Primary ● Predicate and functions similarly as noted.
The aligners are clear plastic, customized sequential ● aligners with the same intended use and mechanism of action as the Secondary Predicate and Reference K180107:
- They are intended for realignment of teeth during . orthodontic treatment of malocclusions by way of continuous gentle force.
- They use the same thermoplastic materials as the ● Secondary Predicate.
- . They are thermoformed using similar processes as the Secondary Predicate and using the same processes as the Reference Device (K180107).

The subject device software and the Primary Predicate software have proprietary differences, but they have the same intended use and function equivalently. Furthermore, both Reference devices use the same software.

The only differences between the subject device aligners and the Secondary Predicate are the minor proprietary differences in the processes; those processes are standard in this field for thermoforming/manufacturing clear aligners. Furthermore they are the same processes used for Reference aligner K180107.

Details follow on the Substantial Equivalence Comparison Tables (Table A for the PNN code; and Table B for NXC code).

Based on the documentation presented in the 510(k), as Substantial summarized herein, it can be concluded that these clear aligner Equivalence systems are substantially equivalent to the Predicate devices. Conclusion:

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Substantial Equivalence Comparison Tables

Trade Name:	Subject Device:Blue Sky Plan Software, &	Primary Predicate:iOrtho	Comparisonto Predicate	Trade Name:	Subject Device:Blue Sky Plan Software, &Blue Sky Bio Aligner Z andBlue Sky Bio Aligner Z FLX	Secondary Predicate:uLab Systems DentalAligner Kit	Comparisonto Predicate
	Blue Sky Bio Aligner Z andBlue Sky Bio Aligner Z FLX			510(k) #	K232653	K192596	n/a
510(k) #	K232653	K223518	n/a	Manufacturer	Blue Sky Bio, LLC	uLab Systems, Inc.	n/a
Manufacturer	Blue Sky Bio, LLC	Shanghai EA MedicalInstruments Co., Ltd.	n/a	Device Name21 CFRProduct CodeClass	Sequential Aligner &Orthodontic Software872.5470PNN & NXC2	Sequential Aligner872.5470NXC2	Same
Device Name21 CFRProduct CodeClass	Orthodontic Software &Sequential Aligner872.5470PNN & NXC2	Orthodontic Software872.5470PNN2	Same	Intended Use	Same as Table A above	The uLab Systems DentalAligner is indicated for thealignment of permanent teethduring orthodontic treatmentof malocclusions by way ofcontinuous gentle forces.	Same alignerIntended Useas bothPredicates.
Intended Use	Blue Sky Plan Softwareorthodontic module is intendedfor use as a medical front-enddevice providing tools formanagement of orthodonticmodels, systematic inspection,detailed analysis, treatmentsimulation and virtual designof a series of dental castswhich may be used forsequential aligner trays andaligners, based on 3D modelsof the patient's dentition beforethe start of an orthodontictreatment. It can also beapplied during the treatment toinspect and analyze theprogress of treatment, and atthe end of treatment toevaluate if the outcome isconsistent with theplanned/desired treatmentobjectives.Blue Sky Bio Aligner Z andBlue Sky Bio Aligner Z FLXare series of clear, lightweight,plastic appliances indicated forthe treatment of toothmalocclusions in patients withpermanent dentition (i.e. allsecond molars). Utilizing aseries of incremental toothmovements, it sequentiallypositions teeth by way ofcontinuous force.	iOrtho is intended for use as amedical front-end deviceproviding tools for managementof orthodontic cases,systematic inspection, detailedanalysis, treatment simulationand virtual appliance designoptions (Export of Models,Indirect Bonding TransferMedia, Sequential aligners)based on 3D models of thepatient's dentition before thestart of an orthodontictreatment. It can also beapplied during the treatment toinspect and analyze theprogress of the treatment. It canbe used at the end of thetreatment to evaluate if theoutcome is consistent with theplanned/desired treatmentobjectives.The use of iOrtho requires theuser to have the necessarytraining and domain knowledgein the practice of orthodontics,as well as to have received adedicated training in the use ofthe software.	SamesoftwareIntended Useas thePrimaryPredicate	Mechanism ofAction ofSequentialAligner Trays	Orthodontic tooth movementsthrough forces applied by theappliance to the dentition aseach tooth follows theprogrammed displacementbased on doctor's prescription.	Orthodontic tooth movementsthrough forces applied by theappliance to the dentition aseach tooth follows theprogrammed displacementbased on doctor'sprescription.	SE
The use of the Blue Sky PlanSoftware module requires theuser to have the necessarytraining and domainknowledge in the practice oforthodontics, as well as tohave received a dedicatedtraining in the use of thesoftware.			Treatmentplanning	Use of orthodontic softwareprogram	Use of orthodontic softwareprogram	SE
SupportedAnatomic Area	Maxilla/Mandible	Maxilla/Mandible	SE	Method of Use	Each customized aligner isworn as prescribed for 20-22hours per day	Each customized aligner isworn as prescribed for 20-22hours per day	SE
Mechanism ofAction	Medical front-end software asdescribed in Intended Usestatement	Medical front-end software asdescribed in Intended Usestatement	SE.	Material andForm	Sheet of thin thermoformedpolyurethane or copolyesterand polyurethane composite	Sheet of thin thermoformedpolyurethane or copolyesterand polyurethane composite	SE toSecondaryPredicate
SoftwareCharacteristics	• Manages patient & case basedata• Collects study material• Segments study material• Aligns study material• Measures study material• Measures point selection• Analyzes study material• Prepares treatmentsimulations and options• Designs virtual appliances• Surface scans for intraoralscanners• Surface scans from STL files	• Manages patient & case basedata• Collects study material• Segments study material• Aligns study material• Measures study material• Measures point selection• Analyzes study material• Prepares treatment simulationsand options• Designs virtual appliances• Surface scans for intraoralscanners• Surface scans from STL files	SE	Biocompatibility	Materials shown to bebiocompatible and non-toxic.	Materials shown to bebiocompatible and non-toxic.	SE toSecondaryPredicate
Rx or OTC	Rx only	Rx only	SE	Rx or OTC	Rx only	Rx only	SE

Table A – Comparison of Orthodontic Software

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Table B: Comparison of Sequential Aligners

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.