(279 days)
No
The device description and performance studies focus on mechanical force and clinical trial results, with no mention of AI or ML.
Yes.
The device is used in the movement and alignment of teeth during orthodontic treatment of malocclusion, which is a therapeutic intervention to correct a medical condition.
No
The device is used for movement and alignment of teeth during orthodontic treatment of malocclusion, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states the system is composed of a custom-made dental mouthpiece and a Personal Treatment Controller (PTC) which provides compressed air, indicating significant hardware components.
Based on the provided information, the Aerodentis System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Aerodentis System is a mechanical device used to physically move and align teeth within the mouth. It directly interacts with the patient's teeth and does not involve the analysis of biological specimens.
The description clearly states its function is to apply pulsatile mechanical force to achieve orthodontic tooth movement. This is a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Aerodentis System is indicated for use in movement of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments.
The system is composed of two primary components:
- . A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner.
- . The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, mandibular, maxillary
Indicated Patient Age Range
adults and pediatric patients
Intended User / Care Setting
dental practitioner
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
A single center, controlled, clinical trial was conducted comparing the investigational Aerodentis System to the Invisalign control. 28 subjects were enrolled in the investigational arm and 15 in the control. 7 subjects dropped from the study (5 from the investigational arm, and 2 from the control).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed to establish equivalence:
- . Balloon leak and fatigue testing
- Aerodentis System force analysis .
- . FEA to support use life
- . Biocompatibility testing per ISO 10993-3, -5 and -10
- . Software validation per FDA guidance
- IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 testing
A single center, controlled, clinical trial was conducted comparing the investigational Aerodentis System to the Invisalign control. 28 subjects were enrolled in the investigational arm and 15 in the control. 7 subjects dropped from the study (5 from the investigational arm, and 2 from the control). Subjects were followed until the average score of the mandibular and maxillary teeth achieved a Little's Irregularity Index (LII) of 1.5 or less or until 15 months of treatment, whichever came first. Safety was assessed by recording adverse events and radiographic assessment of root resorption. Efficacy was assessed by achieving an average LII score of 1.5 or less.
There were no adverse events reported throughout the study for either treatment arm. In addition, no clinically significant root resorption was observed for either group. Thus, both devices have excellent safety profiles. All subjects that completed treatment achieved an average LII score of 1.5 or less. While the time to treatment until success was longer for the subject device, once accounting for actual hours of device use, the Aerodentis System provided statistically significantly higher rates of tooth movement. This allows the user to achieve tooth alignment while being free of all appliances during normal working hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K181739 Align Technology, Inc.'s Invisalign System
Reference Device(s)
K130643 Orthoaccel Technologies, Inc.'s Acceledent
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 6, 2020
Dror Orthodesign % Janice Hogan Partner Hogan Lovelle US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K192069
Trade/Device Name: Aerodentis System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 10, 2020 Received: April 10, 2020
Dear Ms. Janice Hogan:
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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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
510(k) Number (if known)
Device Name
Aerodentis System
Indications for Use (Describe)
The Aerodentis System is indicated for use in movement of teeth during orthodontic treatment of malocclusion.
Type of Use (Select one or both, as applicable)区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 3
K192069 510(k) SUMMARY Aerodentis System
Submitter
Dror Orthodesign, Inc. 7 Hartom St., Mount Hotzvim Jerusalem, Israel 9777507
Phone: +972 74 700 6700 Facsimile: +972 74 700 6767
Contact Person: Michael Nadav
Date Prepared: May 4, 2020
Name of Device:
Aerodentis System
Common or Usual Name:
Sequential Aligner
Classification Name:
872.5470 Orthodontic plastic bracket
Regulatory Class:
Class II
Product Code:
NXC
Primary Predicate:
K181739 Align Technology, Inc.'s Invisalign System
Reference Device:
K130643 Orthoaccel Technologies, Inc.'s Acceledent
Device Description:
The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10
4
hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments.
The system is composed of two primary components:
- . A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner.
- . The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube
Indications for Use:
The Aerodentis System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.
Summary of Technological Characteristics:
| | Dror Orthodesign
Aerodentis System
(K192069) | Align Technology, Inc.
Invisalign System
(K181739) | Orthoaccel
Technologies, Inc.
Acceledent Aura
(K130643) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Aerodentis System is
indicated for use in
movement and alignment of
permanent teeth during
orthodontic treatment of
malocclusion. | The Invisalign System is
indicated for the
orthodontic treatment of
malocclusion. | AcceleDent® Aura is
intended for use
during orthodontic
treatment. It is used
in conjunction with
orthodontic
appliances such as
braces and helps
facilitate minor
anterior tooth
movement. |
| User
Population | The Aerodentis System is
suitable for adults and
pediatric patients with full
complement of permanent
teeth. It is suitable for Class
1 and 2 malocclusions,
including crowding,
proclination and
retroclination. The following
movements are supported:
tipping and uprighting of
anterior teeth, and rotation of
incisors. | The Invisalign System is
suitable for adults and
pediatric patients with full
complement of permanent
teeth. It is suitable for Class 1
and 2 malocclusions,
including crowding,
proclination and
retroclination. The following
movements are supported:
tipping and uprighting of
anterior teeth and rotation of
incisors. | AcceleDent® Aura is an
orthodontic accessory
for the treatment of
tooth malocclusion. It is
used as an adjunctive
therapy for patients
with orthodontic
appliances such as
braces to help facilitate
tooth movement. |
| Components | Mouthpiece and
Personalized Treatment
Controller | Incremental sets of
aligners | Activator,
Mouthpiece and
Travel Case |
5
| Principles of
Operation | Inflation of the balloon within
the Mouthpiece provides
pressure to the malpositioned
teeth to move them into the
desired position over time. | Incremental set of aligners
provides pressure to the
malpositioned teeth to move
them into the desired position
over time. | Uses soft pulse
technology and cyclic
forces to accelerate the
movement of teeth |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Pressure
Application | Pulsatile | Constant | Pulsatile |
| Daily Treatment
Length | 8 - 14 hr/day | 24 hr/day | 20 minutes per day
during Orthodontic
treatment |
| Software | Yes; used to develop a
patient-specific plan and
control treatment delivery. | Yes; used to develop a
patient specific plan. | Not Applicable |
Performance Data:
The following testing was performed to establish equivalence:
- . Balloon leak and fatigue testing
- Aerodentis System force analysis .
- . FEA to support use life
- . Biocompatibility testing per ISO 10993-3, -5 and -10
- . Software validation per FDA guidance
- IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 testing
A single center, controlled, clinical trial was conducted comparing the investigational Aerodentis System to the Invisalign control. 28 subjects were enrolled in the investigational arm and 15 in the control. 7 subjects dropped from the study (5 from the investigational arm, and 2 from the control). Subjects were followed until the average score of the mandibular and maxillary teeth achieved a Little's Irregularity Index (LII) of 1.5 or less or until 15 months of treatment, whichever came first. Safety was assessed by recording adverse events and radiographic assessment of root resorption. Efficacy was assessed by achieving an average LII score of 1.5 or less.
There were no adverse events reported throughout the study for either treatment arm. In addition, no clinically significant root resorption was observed for either group. Thus, both devices have excellent safety profiles. All subjects that completed treatment achieved an average LII score of 1.5 or less. While the time to treatment until success was longer for the subject device, once accounting for actual hours of device use, the Aerodentis System provided statistically significantly higher rates of tooth movement. This allows the user to achieve tooth alignment while being free of all appliances during normal working hours.
Conclusion:
The Aerodentis System is substantially equivalent to the Invisalign System.