(84 days)
No
The description focuses on standard dental software for planning and design, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
Yes
The device aligns teeth during orthodontic treatment of malocclusion, which is a therapeutic function.
No
The device, Ohlendorf Clear Aligner, is an orthodontic appliance used for teeth alignment. While its design involves input from an evaluation of the patient's teeth and uses software for planning, its primary function is therapeutic (aligning teeth) rather than diagnostic (identifying a disease or condition). The software mentioned (Ortho Analyzer) is used for orthodontic diagnosis, but the Ohlendorf Clear Aligner itself is the physical treatment device.
No
The device description clearly states that the device consists of "a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays" which are physical hardware components. While software is used in the design process, the final device is a physical product.
Based on the provided information, the Ohlendorf Clear Aligner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of transfused blood.
- Ohlendorf Clear Aligner's Function: The Ohlendorf Clear Aligner is a physical device used to mechanically move teeth. It is a therapeutic device, not a diagnostic one.
- Input Data: While it uses scans or impressions of teeth, this data is used for planning and manufacturing the physical aligners, not for analyzing biological specimens to diagnose a condition.
- Purpose: The purpose is to align teeth during orthodontic treatment, which is a physical intervention, not a diagnostic assessment.
The device description clearly outlines its function as a series of physical aligner trays used for tooth movement, which falls under the category of orthodontic appliances, not IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Ohlendorf Clear Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane.
A dental clinician prescribes the Ohlendorf Clear Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to the using standard dental software for planning the tooth alignments.
The software used is Ortho Analyzer by 3Shape (Reference device K180941). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models.
After the plan is developed by Ohlendorf, the prescribing dental clinician reviews and approves the model scheme before the 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-polyester 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoral scans or physical impressions 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-clinician
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)
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.
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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K210540
| Submitter Name: | Ohlendorf Appliance Laboratory |
|---|---|
| Submitter Address: | 2840 Clark Avenue |
| 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 | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 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 |
| during orthodontic treatment of malocclusion in patients with | |
| permanent dentition (i.e. all second molars). The Ohlendorf Clear | |
| Aligner positions teeth by way of continuous gentle force. | |
| Device Description, | |
| and Summary of | |
| Technological | |
| Characteristics | The Ohlendorf Clear Aligner consists of a series of dental-clinician |
| prescribed customized clear plastic removable orthodontic aligner | |
| trays that are made from a clear, thin thermoformed polyurethane. |
A dental clinician prescribes the Ohlendorf Clear Aligner based on
an evaluation of the patient's teeth. Either intraoral scans or
physical impressions of the patient's teeth are taken, after which
the clinician determine course of treatment with the system. The
clinician completes a prescription form using standard dental
software used for tooth alignment. The series of plastic aligner
trays are designed according to the using standard dental
software for planning the tooth alignments.
The software used is Ortho Analyzer by 3Shape (Reference
device K180941). It is used for managing 3D scanned orthodontic
models, orthodontic diagnosis by measuring, analyzing, inspecting
and visualizing 3D scanned orthodontic models, virtual planning of
orthodontic treatments by simulating tooth movements and design
of a variety of orthodontic appliances based on 3D scanned
orthodontic models.
After the plan is developed by Ohlendorf, the prescribing dental
clinician reviews and approves the model scheme before the |
4
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.
5
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.
6
| | Proposed: Ohlendorf Clear
Aligner | Predicate: Ormco™ Spark™
Aligner System |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K210540 | K182826 |
| Manufacturer | Ohlendorf Applicance Laboratory | Sybron Dental Specialties |
| Classification #
and Name
Product Code
Class | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 |
| Indications for
Use | The 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 Aligner positions
teeth by way of continuous gentle
force. | The Ormco Spark System is
indicated for the alignment of
teeth during orthodontic treatment
of malocclusion in patients with
permanent dentition (i.e. all
second molars). The Ormco
Spark Aligner System positions
teeth by way of continuous gentle
force. |
| Mechanism 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. |
| Description of
Use | Each preformed plastic tray is
worn by the patient as prescribed
by the dental practitioner, usually
a few weeks prior to using the
next sequential aligner tray. | Each preformed plastic tray is
worn by the patient as prescribed
by the dental practitioner, usually
a few weeks prior to using the
next sequential aligner tray. |
| Material | Thin thermoplastic polyurethane
polyester composite resin | Thin thermoplastic polyurethane
polyester composite resin |
| Biocompatible | Yes, meets ISO 10993
requirements | Yes, meets ISO 10993
requirements |
| Prescription Use | Yes, Rx Only | Yes, Rx Only |
| Software Used
for Treatment
Planning /
Manufacturing | Yes | Yes |
| Single Patient
Use | Yes | Yes |
| Non-Sterile
Packaging | Yes | Yes |