Ohlendorf Clear Aligner

K210540 · Ohlendorf Appliance Laboratory · NXC · May 19, 2021 · Dental

Device Facts

• Record ID: K210540
• Device Name: Ohlendorf Clear Aligner
• Applicant: Ohlendorf Appliance Laboratory
• Product Code: NXC · Dental
• Decision Date: May 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.

Device Story

Ohlendorf Clear Aligner consists of customized, clear, thermoformed polyurethane-polyester composite resin trays; prescribed by dental clinicians for orthodontic malocclusion treatment. Input: intraoral scans or physical impressions of patient teeth. Processing: 3Shape Ortho Analyzer software used to manage 3D models, perform orthodontic diagnosis, simulate tooth movements, and plan treatment; clinician reviews and approves digital model scheme. Output: series of sequential aligner trays. Usage: patient wears trays approximately 22 hours/day, changing every 2-3 weeks. Mechanism: continuous gentle force applied to teeth to achieve incremental repositioning. Benefit: gradual correction of tooth misalignment.

Clinical Evidence

Bench testing only. Mechanical properties (tensile strength, elongation, tensile modulus) verified per ASTM D638 for 5-year shelf life. Packaging moisture barrier properties validated. Manufacturing processes validated for design-to-product consistency. Biocompatibility testing performed per ISO 10993 (cytotoxicity, intracutaneous reactivity, oral mucosa irritation, delayed-type hypersensitivity). No clinical or animal data required due to material and design similarity to predicate.

Technological Characteristics

Material: thermoplastic polyurethane-polyester composite resin. Form factor: series of customized, thin, thermoformed clear plastic trays. Energy source: none (passive mechanical force). Connectivity: software-based planning (3Shape Ortho Analyzer). Sterilization: non-sterile. Testing standards: ASTM D638 (mechanical), ISO 10993 (biocompatibility).

Indications for Use

Indicated for alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

• Ormco™ Aligner System (K182826)

Reference Devices

• OrthoSystem™, 3Shape A/S (K180941)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

May 19, 2021

Patsy Trisler, Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

## Re: K210540

Trade/Device Name: Ohlendorf Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 23, 2021 Received: February 24, 2021

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 (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 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

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael E. Adiodha. M.ChE. 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) K210540

Device Name

Ohlendorf Clear Aligner

Indications for Use (Describe)

Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
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| <span style="font-family: Arial;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary – K210540

| Submitter Name: | Ohlendorf Appliance Laboratory |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 2840 Clark Avenue<br>St. Louis, MO 63103 |
| Phone Number: | 800-325-8921 |
| Contact Person: | Kevin Ohlendorf, President and Owner |
| Date Prepared: | May 10, 2021 |
| Device Trade Name: | Ohlendorf Clear Aligner |
| Common Name | Aligner, Sequential |
| Classification Name<br>Number<br>Product Code<br>Regulatory Class | Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Primary Predicate Device: | 182826, Ormco™ Aligner System, Sybron Dental Specialties |
| Reference Device | K180941 OrthoSystem™, 3Shape A/S |
| Indications for Use | Ohlendorf Clear Aligner is indicated for the alignment of teeth<br>during orthodontic treatment of malocclusion in patients with<br>permanent dentition (i.e. all second molars). The Ohlendorf Clear<br>Aligner positions teeth by way of continuous gentle force. |
| Device Description,<br>and Summary of<br>Technological<br>Characteristics | The Ohlendorf Clear Aligner consists of a series of dental-clinician<br>prescribed customized clear plastic removable orthodontic aligner<br>trays that are made from a clear, thin thermoformed polyurethane.<br><br>A dental clinician prescribes the Ohlendorf Clear Aligner based on<br>an evaluation of the patient's teeth. Either intraoral scans or<br>physical impressions of the patient's teeth are taken, after which<br>the clinician determine course of treatment with the system. The<br>clinician completes a prescription form using standard dental<br>software used for tooth alignment. The series of plastic aligner<br>trays are designed according to the using standard dental<br>software for planning the tooth alignments.<br><br>The software used is Ortho Analyzer by 3Shape (Reference<br>device K180941). It is used for managing 3D scanned orthodontic<br>models, orthodontic diagnosis by measuring, analyzing, inspecting<br>and visualizing 3D scanned orthodontic models, virtual planning of<br>orthodontic treatments by simulating tooth movements and design<br>of a variety of orthodontic appliances based on 3D scanned<br>orthodontic models.<br><br>After the plan is developed by Ohlendorf, the prescribing dental<br>clinician reviews and approves the model scheme before the |

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molds are produced. Following approval, Ohlendorf produces the aligner travs. The travs are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The clear, thin, thermoplastic polyurethane-polvester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.

- Mechanism of Action The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. This occurs through forces applied by the appliance to the teeth over time until final correction, according to the dental clinician's prescription, has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patients for approximately 22 hours per day.
#### Device Testing Laboratory Testing

Test data were submitted to:

- assure the mechanical properties of the aligner material ■ meet specifications for up to 5 years shelf life [according to ASTM D638 standard's testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)]:
- . assure the aligner material packaging retains the required moisture barrier properties;
- . validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner's digital design and the manufactured aligners.

All testing met the pre-determined acceptance criteria.

## Biocompatibility

The thermoplastic polyurethane used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:

Part 5 (Cytotoxicity Elution - MEM),

Part 10 (Intracutaneous/Intradermal Reactivity),

Part 10 (Oral Mucosa; Irritation),

Part 10 (Maximization for Delayed-Type Hypersensitivity)

All testing showed that the material met the requirements of the test methods and is safe and biocompatible for the stated intended use.

Animal | Human Testing

Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device.

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Comparison to There are no notable differences comparing the Ohlendorf Clear Aligner to the predicate Ormco Spark Aligner System: Predicate Device:

- The intended use is the same.
- . The mechanism of action is similar.
- I The polyurethane material used to make the aligners is the same.
- I The method of manufacture for producing the customized clear aligners is similar.
- I The use of software for planning and manufacturing are similar.

Substantial Equivalence Conclusion

Based on the documentation presented in the 510(k), as summarized above and illustrated in the following comparison table, it can be concluded that Ohlendorf Clear Aligner is substantially equivalent to the predicate device.

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| | Proposed: Ohlendorf Clear<br>Aligner | Predicate: Ormco™ Spark™<br>Aligner System |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K210540 | K182826 |
| Manufacturer | Ohlendorf Applicance Laboratory | Sybron Dental Specialties |
| Classification #<br>and Name<br>Product Code<br>Class | 21 CFR 872.5470<br>Orthodontic Plastic Bracket<br>NXC<br>2 | 21 CFR 872.5470<br>Orthodontic Plastic Bracket<br>NXC<br>2 |
| Indications for<br>Use | The Ohlendorf Clear Aligner is<br>indicated for the alignment of<br>teeth during orthodontic<br>treatment of malocclusion in<br>patients with permanent dentition<br>(i.e. all second molars). The<br>Ohlendorf Clear Aligner positions<br>teeth by way of continuous gentle<br>force. | The Ormco Spark System is<br>indicated for the alignment of<br>teeth during orthodontic treatment<br>of malocclusion in patients with<br>permanent dentition (i.e. all<br>second molars). The Ormco<br>Spark Aligner System positions<br>teeth by way of continuous gentle<br>force. |
| Mechanism of<br>Action | Alignment of teeth by application<br>of continuous gentle force, by<br>sequential use of preformed<br>plastic trays. | Alignment of teeth by application<br>of continuous gentle force, by<br>sequential use of preformed<br>plastic trays. |
| Description of<br>Use | Each preformed plastic tray is<br>worn by the patient as prescribed<br>by the dental practitioner, usually<br>a few weeks prior to using the<br>next sequential aligner tray. | Each preformed plastic tray is<br>worn by the patient as prescribed<br>by the dental practitioner, usually<br>a few weeks prior to using the<br>next sequential aligner tray. |
| Material | Thin thermoplastic polyurethane<br>polyester composite resin | Thin thermoplastic polyurethane<br>polyester composite resin |
| Biocompatible | Yes, meets ISO 10993<br>requirements | Yes, meets ISO 10993<br>requirements |
| Prescription Use | Yes, Rx Only | Yes, Rx Only |
| Software Used<br>for Treatment<br>Planning /<br>Manufacturing | Yes | Yes |
| Single Patient<br>Use | Yes | Yes |
| Non-Sterile<br>Packaging | Yes | Yes |

# Substantial Equivalence Comparison