(4 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software-generated sequences and physical forces, not AI/ML algorithms.
Yes
The device is described as "Biotech Dental SMILERS® aligners ... intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states," which is a therapeutic function for orthodontic treatment of malocclusion.
No
The device is described as an aligner for orthodontic treatment to move teeth, positioning them using continuous gentle force. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states the device is a series of clear plastic removable aligners, which are physical hardware components. While software is used in the manufacturing process ("software-generated sequence of intermediate states"), the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the SMILERS® aligners are "clear plastic removable aligners intended to incrementally move a patient's teeth". This is a physical device that directly interacts with the patient's teeth for mechanical movement.
- Intended Use: The intended use is for "alignment of teeth... during orthodontic treatment of malocclusion". This is a therapeutic purpose, not a diagnostic one.
- Lack of Biological Sample Testing: There is no mention of the device being used to test any biological samples from the patient.
The device is a therapeutic orthodontic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS aligners position teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Biotech Dental SMILERS® aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states. Biotech Dental SMILERS® sequentially reposition teeth by way of continuous gentle force.
Special orthodontic aligner treatment planning software, such as Nemocast (K193003) is used to virtually segment and reposition teeth to their desired position for each stage of treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars)
Intended User / Care Setting
Prescription Use
treating dental practitioner / Dental Professional
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)
Non-clinical Performance Testing:
- A manufacturing validation was performed which demonstrated the dimensional accuracy of the manufacturing process for SMILERS®. Cases were planned using Nemocast software (K193003) and the aligners were produced using the standard manufacturing process. The validation evaluated dimensional accuracy of manufacturing aids and the final finished device.
- A fit validation was performed where treatment planned and manufactured aligner cases were qualitatively evaluated by a qualified individual to determine if the Subject device performs as intended.
- A shelf-life/aging study was performed to assess the impact of time-dependent material degradation within the stated shelf-life of the device.
- Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". A chemical characterization was performed according to ISO 10993-18:2020.
- The following biological tests were performed: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Endotoxins (ANSI/AAMI ST72:2019).
Key Results: Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
Clinical Testing:
No clinical data is included in this submission. The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC.
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 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.
September 20, 2021
Biotech Dental Smilers, SAS % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K212961
Trade/Device Name: Smilers Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: September 15, 2021 Received: September 16, 2021
Dear Prithul Bom:
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.
1
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 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. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SMILERS®
Indications for Use (Describe)
Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS aligners position teeth by way of continuous gentle force.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K212961 510(k) Summary Biotech Dental SMILERS® 9/6/2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Biotech Dental Smilers, SAS
305, Allée de Craponne
13300 Salon de Provence |
|--------------------------------|----------------------------------------------------------------------------------|
| Telephone: | +33 04 90 44 60 60 |
| Fax: | +33 04 90 44 60 61 |
| Official Contact: | Delphine Mercier, VP Compliance |
| Email: | d.mercier@biotech-dental.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name: | SMILERS® |
| Common Name: | Aligners, sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification Regulations: | 21 CFR 872.5470 |
| Device Class: | Class II |
| Product Code: | NXC |
Review Panel: Dental Products Panel Reviewing Branch: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) Dental Devices (DHT1B)
PREDICATE DEVICE INFORMATION
The devices within this submission are the same or highly similar in indications, intended use and design principles to the following predicate device:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K180346 | Byte Aligner System | Straight Smile, LLC |
DEVICE DESCRIPTION
The Biotech Dental SMILERS® aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states. Biotech Dental SMILERS® sequentially reposition teeth by way of continuous gentle force.
Special orthodontic aligner treatment planning software, such as Nemocast (K193003) is used to virtually segment and reposition teeth to their desired position for each stage of treatment.
The technology and overall process is the same as that used by the Predicate device, Byte Aligner System (K180346) and other sequential aligner systems currently being legally-marketed.
4
INTENDED USE / INDICATIONS FOR USE
Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS® aligners position teeth by way of continuous gentle force.
EQUIVALENCE TO MARKETED DEVICE
The table below compares Indications for Use and Technological Characteristics of the Subject device and Predicate devices.
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| SMILERS® | |||
| Biotech Dental Smilers, SAS | Byte Aligner System | ||
| Straight Smile, LLC | |||
| K180346 | |||
| Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |
| Intended Use/ | |||
| Indications for Use | Biotech Dental SMILERS® aligners are indicated for the | ||
| alignment of teeth in patients with permanent | |||
| dentition (i.e., all second molars) during orthodontic | |||
| treatment of malocclusion. SMILERS® aligners position | |||
| teeth by way of continuous gentle force. | The Byte Aligner System is indicated for the treatment of | ||
| tooth malocclusion in patients with permanent dentition | |||
| (i.e., all second molars). The Byte Aligner system | |||
| positions teeth by way of continuous gentle force. | Highly Similar | ||
| Intended Population | Individuals with permanent dentition. | Individuals with permanent dentition. | Same |
| Mode of action | Orthodontic movement occurs through continuous | ||
| gentle forces applied to the dentition as each tooth | |||
| follows the programmed displacement based on a | |||
| doctor's prescription. | Orthodontic movement occurs through continuous | ||
| gentle forces applied to the dentition as each tooth | |||
| follows the programmed displacement based on a | |||
| doctor's prescription. | Same | ||
| Method of use | Each aligner is worn by the patient as determined by | ||
| the treating dental practitioner, generally for 2 weeks | |||
| prior to being replaced by the next aligner in sequence. | |||
| This is repeated for a duration as prescribed by a Dental | |||
| Professional. | Each aligner is worn by the patient as determined by the | ||
| treating dental practitioner, generally for 2 weeks prior | |||
| to being replaced by the next aligner in sequence. This is | |||
| repeated for a duration as prescribed by a Dental | |||
| Professional. | Same | ||
| Material | Thermoplastic polymer (polyethylene terephthalate | ||
| glycol or PETG) | Thermoplastic polymers (polyethylene terephthalate | ||
| glycol or PETG) | Same | ||
| Appliance | |||
| Application | Removable | Removable | Same |
| Design | Image: clear aligner | Image: clear aligner | Highly Similar |
| Biocompatible | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Same |
Predicate Device Comparison Table
The wording of the Indications for Use statements differs only in the device name.
TECHNOLOGICAL CHARACTERISTICS
Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action, method of use and intended patient population are the same as the Predicate device and supports a determination of substantial equivalence.
The Subject and Predicate devices are both fabricated of non-sterile, biocompatible thermoplastic PETG material which supports a determination of substantial equivalence.
5
NON-CLINICAL PERFORMANCE TESTING
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed which demonstrated the dimensional accuracy of the manufacturing process for SMILERS®. Using Nemocast software (K193003), cases were planned and the standard manufacturing process used to produce aligners from the treatment plans. The manufacturing validation evaluated dimensional accuracy of manufacturing aids as well as the final finished device. Additionally, a fit validation was performed where treatment planned and manufactured aligner cases were qualitatively evaluated by a qualified individual to determine if the Subject device performs as intended.
A shelf-life/aging study was performed to assess the impact of time-dependent material degradation within the stated shelf-life of the device.
Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". A chemical characterization was performed according to ISO 10993-18:2020.
The following biological tests were performed:
| Biological Endpoint | Relevant Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2010 |
| Irritation | ISO 10993-10:2010 |
| Endotoxins | ANSI/AAMI ST72:2019 |
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use as was also done for the Predicate device.
CLINICAL TESTING
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical data is included in this submission.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices are highly similar differing only in device name. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through non-clinical performance testing.