(198 days)
Not Found
No
The description focuses on the physical aligners and the digital treatment plan created by a dental professional. There is no mention of AI/ML in the device description, performance studies, or key metrics. The process flow validation compares the finished device to the software output, not an AI/ML model's output.
No
The device, Ensmile Dental Plastic Aligners, is used for the alignment of teeth during orthodontic treatment of malocclusion, which is a therapeutic purpose. However, the question specifically asks if the device is a "therapeutic device" which typically refers to devices that treat a disease, injury, or medical condition. While malocclusion can be considered a condition that requires treatment, the device itself is an orthodontic appliance rather than a therapeutic device in the conventional sense of actively treating a disease or injury.
No
The device is described as an aligner for tooth movement, not a tool for diagnosing conditions.
No
The device description explicitly states that the device is a sequence of transparent aligners made from thermoformed polyurethane plastic, which is a physical material, not software. The performance studies also include testing of the physical aligners.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "alignment of teeth during orthodontic treatment of malocclusion." This is a direct treatment of a physical condition within the body.
- Device Description: The device is a physical object (aligners) used to apply force to teeth. It is not used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about the body's state. This device acts on the body to correct a physical alignment issue.
N/A
Intended Use / Indications for Use
Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Ensmile is intended to be used for the alignment of teeth during orthodontic treatment of malocclusion.
The Ensmile is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Ensmile is a sequence of transparent aligners created from a digital orthodontic treatment plan. The Ensmile aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth; mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
As part of demonstrating safety and effectiveness of Ensmile and in showing substantial equivalence to the primary predicate device that are subject to this 510(k) submission, Ensmile Pvt Ltd completed a number of non-clinical performance tests. Ensmile meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets.
- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.
In all instances, the Ensmile functioned and Biocompatibility Testing, and Process Flow Validation observed was as expected.
There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.
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.
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 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.
March 16, 2023
Ensmile Pvt Ltd Mirza Rehman Head of Firm Main Canal RD, No. 2 Block H Johar Town, Lahore 54000 PAKISTAN
Re: K222619
Trade/Device Name: Ensmile Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 13, 2023 Received: February 13, 2023
Dear Mirza Rehman:
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,
Michael E. Adjodha -S
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
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Indications for Use
510(k) Number (if known) K222619
Device Name Ensmile
Indications for Use (Describe)
Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
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 contains the logo for "ensmile Invisible Dental Aligners". The logo features the word "ensmile" in a bold, blue sans-serif font. Below "ensmile" is the text "Invisible Dental Aligners" in a smaller, lighter blue font. Above the word "ensmile" are two curved, yellow lines that resemble a smile.
510(k) Summary
510(k) SUMMARY Ensmile Pvt Ltd's Ensmile 510K Number: K222619
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
COMPANY'S NAME AND ADDRESS
Ensmile Pvt Ltd Main Canal RD, No. 2 Block H Johar Town Lahore Pakistan 54000
Phone: +92 42 111 321 111
Contact Person: Mirza Gohar Rehman Date Prepared: March 16, 2023
Name of Device and Name/Address of Sponsor
| Name of Device: | Ensmile |
|---|---|
| Common or Usual Name: | Dental Plastic Aligners |
| Classification Name: | Orthodontic Plastic Brackets - Sequential Aligners (21 CFR 892.5470) |
| Regulatory Class: | II |
| Product Code: | NXC |
Primary Predicate Devices
| Invisalign System | K081960 |
|---|---|
| Align Technology, Inc. |
Intended Use / Indications for Use
The Ensmile is intended to be used for the alignment of teeth during orthodontic treatment of malocclusion.
The Ensmile is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.
Technological Characteristics
The Ensmile Aligners that are produced have the same technological characteristics as the primary predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.
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Image /page/4/Picture/0 description: The image shows the logo for Ensmile Invisible Dental Aligners. The logo features two curved yellow lines above the word "ensmile" in blue. Below "ensmile" is the text "Invisible Dental Aligners" in a smaller blue font. The logo is simple and modern, with a focus on the brand name and product.
Ensmile Pvt Ltd
510(k) Summary
In both devices, the aligners are created by thermoforming commercially available plastic material. The Ensmile Aligners are thermoformed by Ensmile Pvt Ltd and in the case of the primary predicate device; the aligners are thermoformed by an outside laboratory.
The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
Performance Data
As part of demonstrating safety and effectiveness of Ensmile and in showing substantial equivalence to the primary predicate device that are subject to this 510(k) submission, Ensmile Pvt Ltd completed a number of non-clinical performance tests. Ensmile meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets.
- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.
In all instances, the Ensmile functioned and Biocompatibility Testing, and Process Flow Validation observed was as expected.
| Feature | Proposed Device
Ensmile | Primary Predicate Device
Invisalign System |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K222619 | K081960 |
| Manufacturer | Ensmile Pvt Ltd | Align Technology, Inc. |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Device
Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC |
| Device Class | Class II | Class II |
| Indications for
Use | Ensmile is indicated for the alignment
of teeth during orthodontic treatment
of malocclusion. | The Invisalign System is indicated for
the alignment of teeth during
orthodontic treatment of malocclusion. |
| Feature | Proposed Device | Primary Predicate Device |
| K Number | Ensmile
K222619 | Invisalign System
K081960 |
| Device Description | The Ensmile is a sequence of
transparent aligners created from a
digital orthodontic treatment plan.
The Ensmile aligner is fabricated of a
transparent thermoformed
polyurethane plastic. Each aligner
delivery a unique combination of minor
forces to create the planned tooth
movement.
The digital orthodontic treatment plan
is created by a dental health
professional.
The Ensmile Aligner incorporates the
use of attachments to create spaces
and force points in order to cause
minor tooth movement. These force
points are located in specific areas and
positioned in such a way that they
provide a continuous force which
slowly dissipates over time on the tooth
to be moved for as long as the aligner is
worn. | The current Invisalign system is a series
of clear plastic aligners that are used to
replace traditional orthodontic wires
and brackets for the alignment of
maloccluded or misaligned teeth.
This series of aligners moves the teeth
gently, and in small increments, from
their original to their final treated
position for improved dental
alignment. |
| Mode of
Action | Orthodontic tooth
movement occurs through
forces applied by the
appliance to the dentition
as each tooth follows the
programmed displacement
based on a doctor's
prescription | Orthodontic tooth
movement occurs through
forces applied by the
appliance to the dentition
as each tooth follows the
programmed displacement
based on a doctor's
prescription |
| Anatomy Location | Mouth; mucosal | Mouth; mucosal |
| Size | Patient specific | Patient specific |
| Manufacturing
Method | Thermoforming | Thermoforming |
| Material | Thermoplastic Polymer | Thermoplastic Polymer |
| Material
Properties | Demonstrates sufficient
tensile strength, elasticity,
ductility, chemical resistance,
and clarity for use as a clear
tray aligner. | Demonstrates sufficient
tensile strength, elasticity,
ductility, chemical resistance,
and clarity for use as a clear
tray aligner. |
| Software Used | Yes | Yes |
| Feature | Proposed Device
Ensmile | Primary Predicate Device
Invisalign System |
| K Number | K222619 | K081960 |
| Workflow | | |
| Design | Image: Ensmile aligner | Image: Invisalign aligner |
Substantial Equivalence
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Image /page/5/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue.
Ensmile Pvt Ltd
510(k) Summary
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Image /page/6/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue.
Ensmile Pvt Ltd
510(k) Summary
Ensmile has the same intended uses and similar indications, technological characteristics, Manufacturing Method, Material Used and principles of operation as its primary predicate device. Ensmile is substantial equivalent to the Invisalign System.
There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.
Conclusions
Ensmile Aligners moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the primary predicate device, Invisalign System.
The conclusions drawn from the data included in this submission, demonstrates that the Ensmile Aligner is substantially equivalent to the primary predicate devices cleared under premarket notification K081960 (Primary Predicate Device) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.