(267 days)
No
The description focuses on the physical aligners and the use of standard orthodontic software for design, with no mention of AI or ML capabilities.
Yes.
The device is used for orthodontic treatment of misalignment and malocclusion, which corrects a health problem and restores the teeth to their proper function.
No
The device is an aligner system used for orthodontic treatment (alignment of teeth), not for diagnosing conditions.
No
The device description clearly states that the Bioliner™ aligner system is a sequential set of removable aligners made of clear plastic, which are physical hardware components. While software is used in the design process, the device itself is a physical product.
Based on the provided information, the Bioliner™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the physical alignment of teeth through orthodontic treatment. This is a mechanical action on the body, not a test performed on samples taken from the body to provide diagnostic information.
- Device Description: The device is a physical aligner system that applies force to teeth. It does not involve any reagents, samples of bodily fluids or tissues, or analysis of biological markers.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Providing diagnostic information about a disease or condition
The Bioliner™ is clearly described as a medical device used for orthodontic treatment, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Bioliner™ is an aligner system indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Bioliner™ aligner system is used for treatment of misalignment and malocclusion of permanent teeth by use of clear plastic aligners. The Bioliner™ aligner system is a sequential set of removable aligners prescribed by a dentist that are custom made for a specific patient.
Each Bioliner™ sequential aligner introduces subtle changes in the position of the teeth from the previous aligner. Each Bioliner™ is fabricated from 1.0mm thermoplastic. For each patient, the Bioliner™ will be designed by a Five Star Orthodontic Laboratory & Supply, Inc. technician utilizing 3Shape (K152086) orthodontic validated software and tooth movement recommendations from the prescribing dentist. Once fabricated, the Bioliner™ aligners are provided to the dentist, and over a period of time, the dentist provides the next sequential aligner to the patient in order to move the teeth to the desired final position.
The aligners are removable at any time and treatment may be discontinued at any time. The Bioliner™ aligners are a non-sterile, single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed by a dentist.
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)
Clinical testing was not necessary to demonstrate substantial equivalence of the Bioliner™ to the predicate device.
Biocompatibility testing was performed for the Bioliner™ aligners in accordance with ISO 10993-1 and its applicable parts. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required. There is sufficient data to demonstrate substantial equivalence to the predicate device.
A manufacturing validation was performed to ensure the dimensional accuracy of the Bioliner™ aligners through the manufacturing process. This validation demonstrated that the finished Bioliner™ aligners match the software output specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 19, 2019
Five Star Orthodontic Lab & Supply Andrew Loch Sales Manager 2928 Metro Street, Suite 102 Denton, Texas 76207
Re: K182658
Trade/Device Name: Bioliner™ Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 14, 2019 Received: May 17, 2019
Dear Andrew Loch:
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
1
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,
Srinivas Nandkumar, Ph.D. Acting Assistant 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) K182658
Device Name Bioliner™
Indications for Use (Describe)
The Bioliner™ is an aligner system indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo for "Five Star Orthodontic Laboratory & Supply". The logo has a graphic of an atom-like structure with five stars orbiting the center. The text is in bold, and the words "Laboratory & Supply" are smaller than the words "Five Star Orthodontic".
510(k) Summarv
| Submitter: | Five Star Orthodontic Lab & Supply, Inc.
2928 Metro Street. Suite 102
Denton, TX 76207 |
|------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Loch
Sales Manager
Phone: (800) 521-2351
andrew@fivestarortho.com |
| Submission Date: | June 17, 2019 |
| Trade Name: | Bioliner™ |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic Plastic Bracket; 21 CFR 872.5470; NXC |
| Device Classification: | Class II |
| Predicate Device: | K173785, Derby Dental Laboratory Custom Clear Aligner System |
| Reference Devices: | K062828, Dentsply Intl, Inc. Mouthguard and Aligner Materials
K152086, 3Shape A/S 3Shape Ortho System |
Description of Device:
The Bioliner™ aligner system is used for treatment of misalignment and malocclusion of permanent teeth by use of clear plastic aligners. The Bioliner™ aligner system is a sequential set of removable aligners prescribed by a dentist that are custom made for a specific patient.
Each Bioliner™ sequential aligner introduces subtle changes in the position of the teeth from the previous aligner. Each Bioliner™ is fabricated from 1.0mm thermoplastic. For each patient, the Bioliner™ will be designed by a Five Star Orthodontic Laboratory & Supply, Inc. technician utilizing 3Shape (K152086) orthodontic validated software and tooth movement recommendations from the prescribing dentist. Once fabricated, the Bioliner™ aligners are provided to the dentist, and over a period of time, the dentist provides the next sequential aligner to the patient in order to move the teeth to the desired final position.
The aligners are removable at any time and treatment may be discontinued at any time. The Bioliner™ aligners are a non-sterile, single use device.
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Image /page/4/Picture/1 description: The image shows a logo for "Five Star Orthodontic Laboratory & Supply". The logo features a stylized atom symbol with five stars orbiting the nucleus. The text "ORTHODONTIC" is prominently displayed, with "LABORATORY & SUPPLY" written in a smaller font underneath. The words "FIVE STAR" are located above and to the right of the word "ORTHODONTIC".
Intended Use / Indications:
The Bioliner™ is an aligner system indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Predicate Device Comparison:
| Proposed Device | Predicate Device | |
|---|---|---|
| Property or Characteristic | Five Star Orthodontic Laboratory | |
| & Supply, Inc. | ||
| Bioliner™ | Derby Dental Laboratory | |
| Custom Clear Aligner System | ||
| (K173785) | ||
| Device Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC |
| Classification | II | II |
| Indications for Use | The Bioliner™ is an aligner | |
| system indicated for use in the | ||
| alignment of permanent teeth | ||
| through orthodontic treatment of | ||
| misalignment and malocclusion. | The Custom Clear Aligner | |
| System is indicated for use in the | ||
| alignment of permanent teeth | ||
| through orthodontic treatment of | ||
| misalignment and malocclusion. | ||
| Prescription or OTC | Prescription | Prescription |
| Mode of Action | Alignment of teeth by | |
| application of continuous gentle | ||
| force, by sequential use of | ||
| preformed plastic trays. | Alignment of teeth by | |
| application of continuous gentle | ||
| force, by sequential use of | ||
| preformed plastic trays. | ||
| Number of aligner sets to | ||
| complete treatment | Patient specific - determined | |
| during design of aligners | ||
| utilizing orthodontic software | Patient specific - determined | |
| during design of aligners | ||
| utilizing orthodontic software | ||
| Material | Essix Ace Plastic (K062828) | Thin thermoformed polyurethane |
| Sizes | Patient specific | Patient specific |
| Body Location | Mouth | Mouth |
| Manufacturing Process | Thermoformed | Thermoformed |
| Software Used during | ||
| manufacturing | Use of 3Shape Ortho System | |
| (K152086) | Use of 3Shape Ortho System | |
| (K152086) | ||
| Provided Non-Sterile | Yes | Yes |
The Bioliner™ aligners are manufactured from Essix Ace Plastic (K062828), whereas the predicate device is manufactured from polyurethane. Polyurethane is a more flexible material as compared to the thermoplastic material that the Bioliner™ aligners are manufactured from. The thermoplastic material (Essix Ace Plastic) used for the Bioliner™ aligners has been cleared for orthodontic use in
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Image /page/5/Picture/1 description: The image shows the logo for Five Star Orthodontic Laboratory & Supply. The logo features a stylized atom symbol with five stars orbiting the center. The text "FIVE STAR ORTHODONTIC LABORATORY & SUPPLY" is displayed to the right of the atom symbol.
K062828 and the material labeling specifically indicates use of the material for aligners.
A biocompatibility risk assessment has been completed for the Bioliner™ aligners taking into account not only the material used for fabrication, but also the manufacturing processes utilized during fabrication. As identified below, all applicable biocompatibility testing has been performed on the Bioliner™ aligners.
Summary of Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Bioliner™ to the predicate device.
Summary of Non-Clinical Testing:
Biocompatibility testing was performed for the Bioliner™ aligners in accordance with ISO 10993-1 and its applicable parts. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required. There is sufficient data to demonstrate substantial equivalence to the predicate device.
The Bioliner™ aligners are manufactured using 3Shape orthodontic software (K152086). Software validation by Five Star Orthodontic Laboratory and Supply was not required since 3Shape has received 510(k) clearance and has been validated by the manufacturer.
A manufacturing validation was performed to ensure the dimensional accuracy of the Bioliner™ aligners through the manufacturing process. This validation demonstrated that the finished Bioliner™ aligners match the software output specifications.
Conclusion:
Based upon the information presented in this submission, it is concluded that the Bioliner™ system is substantially equivalent to the predicate device in regard to indications for use, design and technology.