(100 days)
Not Found
No
The summary describes a physical dental aligner and its manufacturing process, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of tooth malocclusion" and is designed to "progressively reposition the permanent malocclusion teeth," which are therapeutic actions.
No
This device, Clear Dental Aligners, is designed for the treatment of tooth malocclusion by physically repositioning teeth. It does not perform any diagnostic function such as identifying, screening, monitoring, or predicting a condition.
No
The device description explicitly states the device is a physical, thermoformed dental appliance made of BPA-free material sheets, which is a hardware component.
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, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Clear Dental Aligners described are physical devices worn by the patient to mechanically reposition teeth. They do not involve the analysis of biological specimens.
- Intended Use: The intended use is for the treatment of tooth malocclusion, which is a physical condition, not a diagnosis based on laboratory testing.
- Device Description: The description focuses on the physical properties and function of the aligners as a wearable appliance.
- Lack of IVD-related information: The document does not mention any aspects related to specimen collection, laboratory analysis, or diagnostic information derived from biological samples.
Therefore, the Clear Dental Aligners fall under the category of a medical device used for treatment, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These by patient with monitoring of improvement by orthodontists.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (permanent dentition)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-use by patient with monitoring of improvement by orthodontists.
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)
The following bench testing was performed as part of Design Verification:
- Surface finishing after polishing by two methods - Accepted
- Thickness of aligners after thermoforming with reference to aligner sheets - Accepted
- Aligner shape accuracy after mimicked use for 15 days - Accepted
- 3D Model shape accuracy for effectiveness of aligner punching as per treatment plan - Accepted
The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners. No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan.
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.
ClearCorrect System (K113618)
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.
Not Found
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 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.
February 9, 2023
AMPA Orthodontics Private Limited % Sanjeev Gupta Managing Consultant Intrust A301/A Green Heritage, Plot 79-80, Sector 20 Kharghar, Maharashtra 410210 India
Re: K223338
Trade/Device Name: Toothsi&SmileAligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC. Dated: October 29, 2022 Received: November 1, 2022
Dear Sanjeev Gupta:
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 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,
Bobak Shirmohammadi -S
For Michael Adjodha, M.ChE.,CQIA 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) K223338
Device Name Toothsi&SmileAligners
Indications for Use (Describe)
The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These by patient with monitoring of improvement by orthodontists.
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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Image /page/3/Picture/0 description: The image shows the word "toothsi" in a red, sans-serif font. A curved line is below the "t" in "toothsi", resembling a smile. A four-pointed star is above the "i" in "toothsi".
510 k Summary - Substantial Equivalence Discussion K223338
| A. Name and Address of:
Manufacturer | AMPA Orthodontics Private Limited
1st Floor, Empire Plaza B Wing
Lal Bahadur Shastri Marg
Vikhroli West
Mumbai 400083
Maharashtra, India
Phone/Fax: +91 9820340245
Contact Person: Dr. Manjul Jain (drmanjul@toothsi.in) |
----------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
---|
B. Device Details:
- a) Trade Name: Toothsi & SmileAligners
- b) Common Name: Clear Dental Aligners
- c) Classification Name: Aligner, Sequential
- d) Product Code: NXC
- C. Predicate Device: ClearCorrect System (K113618)
- D. Device Description: The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
- E. Intended Use The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.
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+91 98980000000
1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083
Info@toothsi.in X 0 www.toothsi.in
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Image /page/4/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is lowercase, and the two "o"s are connected. There is a curved line under the first "t" that resembles a smile. There is a four-pointed star to the right of the "i".
F: Comparison of proposed device with predicate device for
| Equivalence
Points | Clear Dental Aligners | ClearCorrect System
(K113618) | Comparison |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | AMPA Orthodontics Pvt. Ltd. | CLEARCORRECT LLC | N/A |
| Product Code | NXC | NXC | Equivalent |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Equivalent |
| Intended
Use/Indications
for Use | The patient specific set of Clear
Dental Aligners are indicated for
the treatment of tooth
malocclusion in patients having
permanent dentition.
These
Aligners position teeth by way of
continuous gentle force. These are
for self-use by patient with
monitoring of improvement by
orthodontists. | The ClearCorrect System is
indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e.
all second molars).
The ClearCorrect System
positions teeth by way of
continuous gentle force | Equivalent |
| Mechanism of
Action | Continuous gentle force to
move the teeth | Continuous gentle force to
move the teeth | Equivalent |
| Material of
Construction | Thermoplastic | Thermoplastic | Equivalent |
| Aligner Material
Thickness
(For different
aligner set) | ~0.5 mm to ~1.0 mm as per
treatment plan | Soft (0.5 mm) | Equivalent |
| | | Medium (0.62 mm) | |
| | | Hard (0.75 mm)
Ultra Hard (1 mm) | |
| Biocompatible | Complies with ISO 10993 (FR# 2-
248 & 2-296) | ISO 10993-1 | Equivalent |
| Prescription
Steps | Approximately 7-14 days/aligner
set as per prescription | Soft (1 Week) | Equivalent |
| | | Medium (1 Week) | |
| | | Hard (1 Week) | |
| Daily Duration of
wear | At least 20-22 hours | 17 hours a day | Equivalent |
| Sterile | Non-Sterile | Non-Sterile | Equivalent |
| Single-Use | Single User Use | Single User Use | Equivalent |
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1* floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083
- +91 98980000000
K
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Image /page/5/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is stylized with a curved line underneath, resembling a smile. There is a four-pointed star to the right of the "i" in toothsi. The font is rounded and sans-serif.
G. Performance Testing Bench (Non-clinical)
The following bench testing was performed as part of Design Verification with purpose define in column 2 of Table 2 below. The reports are presented in sequence along with data tables and figures as applicable in 018_Performance Testing Bench. No separate annexure has been created for this section.
| Table 2: Summary of bench testing performed on design samples of clear dental
aligners | Test Outcome | ||
---|---|---|---|
Sr. | |||
No | Purpose of Bench Testing | Report Number | |
1 | Surface finishing after polishing by two | ||
methods | Report No. AO/DV/R1 | ||
dated 31-12-2021 | Accepted | ||
2 | Thickness of aligners after thermoforming | ||
with reference to aligner sheets | Report No.: AO/DV/R2 | ||
Dated 31-12-2021 | Accepted | ||
3 | Aligner shape accuracy after mimicked use | ||
for 15 days | Report No.: AO/DV/R7 | ||
Dated 10-01-2022 | Accepted | ||
4 | 3D Model shape accuracy for effectiveness | ||
of aligner punching as per treatment plan | Report No.: AO/DV/R3 | ||
Dated 10-01-2022 | Accepted |
The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners. No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan.
H. Substantial Equivalence Discussion
Comparison of specifications with predicate device: The Section F-Table 1 above summarizes the comparison of subject device with predicate device.
- a) Similarities: As it emerges from the review of Section F-Table 1 the characteristics related to Intended Use, Mechanism of Action, Material Thickness, Material of Construction, Prescription Steps are equivalent between predicate and subject devices.
- b) Differences: The duration of wearing aligner is around 17 hours in predicate device and around 22 hours for subject device. This difference is subjective and does not alter safety and performance of the devices. Such difference majorly emerges from the user actions.
Ver 01 Date 2022-12-20
+91 98980000000
1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083
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Image /page/6/Picture/0 description: The image shows the word "toothsi" in red font. The "tooth" part of the word is above a curved line, also in red, that resembles a smile. To the right of the "i" is a red star.
- c) Standards Testing: AMPA Orthodontics Private Limited has performed biocompatibility testing of the subject device by application of ISO 10993 standards which has also been followed by the predicate device manufacturer.
Conclusions: We, therefore, conclude that Clear Dental Aligner manufactured by AMPA Orthodontics Private Limited have substantial equivalence with ClearCorrect Aligners (K113618) Manufactured by ClearCorrect LLC.
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1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083
+91 98980000000 Info@toothsi.in
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