(91 days)
No
The description focuses on traditional manufacturing processes (3D printing, thermoforming) based on digital scans and clinician approval, with no mention of AI or ML in the design or manufacturing process.
Yes.
The device is indicated for the correction of dental malocclusion, addressing a medical condition (malocclusion) through physical intervention (continuous gentle force to position teeth).
No
The device is indicated for the correction of dental malocclusion and works by applying gentle force to reposition teeth, which is a therapeutic function rather than a diagnostic one. The description focuses on its manufacturing process and how it achieves tooth movement, not on identifying a disease or condition. While it uses impressions of teeth, these are for custom fabrication, not for diagnosing malocclusion itself.
No
The device description explicitly states that the SmileSeries™ is comprised of physical aligner trays, which are hardware components. While digital processes are used in the design and manufacturing, the final product is a physical medical device.
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.
- SmileSeries™ Function: The SmileSeries™ is a physical device (aligner trays) used to apply force to teeth for the correction of malocclusion. It directly interacts with the patient's teeth and mouth.
- Input: While it uses impressions (physical or scanned) of the teeth, these are used for manufacturing the physical device, not for analyzing biological specimens.
- Purpose: The purpose is mechanical correction of tooth position, not the analysis of biological samples for diagnostic purposes.
The device description clearly indicates it's a physical orthodontic appliance used for mechanical correction of teeth, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SmileSeries™ is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeries™ positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The SmileSeries™ is 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. SmileSeries™ aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to SmileSeries™. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth / Dental
Indicated Patient Age Range
adult and adolescent 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)
Bench testing was performed to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. A final report 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): 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
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July 14, 2022
Ordont Orthodontic Laboratories, Inc. % Patsy Trisler Regulatory Consultant Trisler Consulting, dba 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K221097
Trade/Device Name: SmileSeries Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: April 13, 2022 Received: April 14, 2022
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
1
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 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 medical devices and radiation-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. Adjodha, 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) K221097
Device Name
SmileSeries™
Indications for Use (Describe)
The SmileSeries™ is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeries™ 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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SECTION 5
510(k) SUMMARY
| SUBMITTER | |
|---|---|
| Submitter Name: | Ordont Orthodontic Laboratories, Inc. |
| Submitter Address: | |
| Contact Person: | |
| Email: | |
| Telephone: | Paul Ruzicka, CDA |
| Paul@ordont.com | |
| 800-325-3698 | |
| Date Prepared: | April 13, 2022 |
| DEVICE | |
| Device Trade Name: | SmileSeries™ |
| Common Name: | Aligner, Sequential (Clear Braces) |
| Classification Name | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Review Panel | Dental |
| PREDICATE DEVICE | Primary Predicate: |
| K202857, ClearPath Aligner, ClearPath Orthodontics | |
| Reference Device: | |
| K180941 Ortho System™, 3Shape A/S | |
| DEVICE | |
| DESCRIPTION | The SmileSeries™ is 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. SmileSeries™ | |
| aligners are provided non-sterile and are customized for each | |
| patient according to the dental clinician's prescription. | |
| The dental health professional (dentist/orthodontist) takes | |
| provides physical or scanned impressions of the patient's teeth | |
| to SmileSeries™. A digital setup of either the scanned | |
| impression or a scan of the physical impression is sent to the | |
| clinician for approval. Upon approval, molds are then created | |
| with 3D-printing technology and the clear aligners are | |
| thermoformed on the molds and laser marked. | |
| The finished, customized aligners are provided to the dental | |
| health care professional who provides them to the patient, | |
| confirming fit and design. The aligner trays are held in place by | |
| pressure and can be removed by the patients at any time. | |
| MECHANISM OF | |
| ACTION | Each aligner in the set is used for the specified period of time, |
| usually 2-3 weeks, to exert gentle force to achieve progressive | |
| realignment of the teeth until the final correction has been | |
| achieved. The daily treatment time is usually 22 hours, or | |
| except during eating, based on the clinician's prescribed | |
| treatment plan. | |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | The thermoplastic material used for the manufacture of the |
| SmileSeries™ aligner is the same material used to make the | |
| predicate ClearPath Aligner. | |
| The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 | |
| by 3Shape A/S (Reference device - K180941). It also is the | |
| same as used for the Predicate. It is used for management of | |
| 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 orthodontic | |
| appliances based on 3D scanned orthodontic models. | |
| INDICATIONS FOR | |
| USE STATEMENT | The SmileSeries™ is a series of clear, lightweight, plastic |
| appliances indicated for the correction of dental malocclusion in | |
| adult and adolescent patients with permanent dentition (i.e. all | |
| second molars). The SmileSeries™ positions teeth by way of | |
| continuous gentle force. | |
| SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable material |
| used to make the SmileSeries™ aligners has been provided in | |
| previous 510(k) submissions to FDA. | |
| PERFORMANCE | |
| TESTING | Bench testing was performed to validate the manufacturing |
| process, to ensure the accuracy of the final thermoformed | |
| aligner compared to the initial digital scan. A final report 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 SmileSeries™ aligner has the same intended use as the |
| predicate device. The thermoplastic material is the same and | |
| the design phase makes the use of the same software as the | |
| predicate. The manufacturing fabrication of the clear aligner | |
| makes use of similar, industry-standard processes with the | |
| same or similar machines and materials. Any differences in the | |
| specific company 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 SmileSeries™ is substantially equivalent to the predicate | |
| ClearPath Aligner in the intended use, design, principle of | |
| operation, technology, and thermoformable material used to | |
| make the aligner. Comparison of all key parameters are | |
| presented in the following SE Comparison table |
4
5
| 510(k) Number | Proposed Device
K | Predicate Device
K202857 | Comparison |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name | SmileSeries™ | ClearPath Aligner | N/A |
| Manufacturer | Ordont Orthodontic
Laboratories, Inc. | ClearPath Orthodontics, Ltd | N/A |
| Classification
Regulation
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 | The SmileSeries™ is a
series of clear, lightweight,
plastic appliances indicated
for the correction of dental
malocclusion in adult and
adolescent patients with
permanent dentition (i.e. all
second molars). The
SmileSeries™ positions teeth
by way of continuous gentle
force. | The ClearPath Aligner is a
series of clear, lightweight,
plastic appliances indicated
for the correction of dental
malocclusion in patients with
permanent dentition (i.e. all
second molars). The
ClearPath Aligner positions
teeth by way of continuous
gentle force. | Same |
| Mode of Action | The removable appliance
applies gentle forces on teeth
according to the plan
prescribed by the doctor. | The removable appliance
applies gentle forces on teeth
according to the plan
prescribed by the doctor | Same |
| Description of
Use | Each removable preformed
plastic tray, prescribed by the
Dr, is worn by the patient
usually for a few weeks, prior
to using the next sequential
aligner tray. | Each removable preformed
plastic tray, prescribed by the
Dr, is worn by the patient
usually for a few weeks, prior
to using the next sequential
aligner tray. | Same |
| Material | Thermoformed plastic | Thermoformed plastic | Same |
| Manufacturing
Process | Forming of plastic sheets on
unique dental models using
thermoforming machine | Forming of plastic sheets on
unique dental models using
thermoforming machine | Same |
| Software Used | Yes, for treatment planning
and 3D printing of models. | Yes, for treatment planning
and 3D printing of models. | Same |
| Prescription
Use | Rx | Rx | Same |
| Biocompatibility | Yes, shown to meet
requirements | Yes, shown to meet
requirements | Same |
| Validation
Testing | Yes, performed | Yes, performed. | Same |