(166 days)
Not Found
No
The description mentions "Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states." This suggests algorithmic processing and interpolation, but there is no mention of AI or ML techniques being used for this generation or interpolation. The process is described as following the Dental Practitioner's prescription, implying a rule-based or deterministic approach rather than a learning-based one.
Yes
The device is indicated for the "treatment of tooth malocclusion," which is a medical condition, by applying "continuous gentle force" to position teeth, thereby restoring proper alignment. This direct treatment of a health condition with the aim of restoring normal function classifies it as a therapeutic device.
No
The device, the Align System, is described as a series of clear plastic appliances (Aligners) used for the treatment of tooth malocclusion. While a Dental Practitioner diagnoses a patient as part of the overall process, the Align System itself is a treatment device (moving teeth) and not a diagnostic one. Its function is to implement the treatment plan derived from a prior diagnosis, not to perform the diagnosis itself.
No
The device description clearly outlines the use of physical components like clear plastic appliances (Aligners), dental stone models, three-dimensional laser scanning technology, rapid prototyping machines, and conventional air pressure devices. While software is used in the process, the final medical device delivered to the patient is a physical appliance, not software.
Based on the provided information, the Align System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Align System is a physical device (a series of clear plastic aligners) that is placed directly in the patient's mouth to physically move teeth. It does not analyze any biological samples or specimens.
- The intended use is for the treatment of tooth malocclusion. This is a therapeutic purpose, not a diagnostic one.
- The device description focuses on the manufacturing process of the aligners and their function in applying force to teeth. There is no mention of analyzing biological samples or providing diagnostic information.
The Align System is a medical device used for orthodontic treatment.
N/A
Intended Use / Indications for Use
The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
Align Technology Inc. (Align) has developed the Align System, which is a series of clear plastic appliances (Aligners) that are intended to replace conventional wire and bracket technology for many orthodontic cases. The series of Aligners moves the patient's teeth in small increments from their original state to a final, treated state. The Align System will use a computer as a tool to assist in creating a series of Aligners that represent sequential movements to generate light and consistent forces on the patient's teeth.
A Dental Practitioner using the Align System diagnoses a patient, determines a treatment plan, and makes dental stone models of a patient's teeth. The Dental Practitioner then sends the molds, along with a prescription for treatment to Align. Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. For each of these intermediate states, a rapid prototyping machine (such as a stereolithography machine) produces corresponding dental molds. In the final step, Align uses a conventional air pressure device (e.g., a Biostar) and commercially available retainer or positioner material (made by Raintree Essix or equivalent) to craft plastic Aligners to fit the developed teeth molds. The models with their corresponding Aligners are then mailed back to the Dental Practitioner. The total number of Aligners can vary from 1 to over 100 per patient, depending on the complexity of the case. The Aligners are individually identified and are dispensed to the patient by the Clinician with specific instructions for use (i.e., the Aligners are to be worn in a prescribed sequence).
Mentions image processing
Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Three-dimensional laser scanning technology to scan dental stone models.
Anatomical Site
Teeth
Indicated Patient Age Range
Patients with permanent dentition (i.e., all second molars).
Intended User / Care Setting
Dental Practitioner / Clinician
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
Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K780619, Class I Exempt, Class I Exempt
Reference Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is a symbol consisting of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2000
Align Technology, Incorporated 881 Martin Avenue Santa Clara, California 95050
Re: K981095
Trade/Device Name: Align System Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: July 30, 1998 Received: July 31, 1998
Dear Mr. Kolesar:
This letter corrects our substantially equivalent letter of September 8. 1998. We are issuing this letter solely because The Align System, as described in the indication for use, is equivalent to an orthodontic plastic bracket.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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 vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
1
Page -2 Mr. Kolesar
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ALIGN TECHNOLOGY, INC. ALIGN SYSTEM SIOK APPLICATION
INDICATIONS FOR USE
K 481095 To Be Assigned By FDA 510(k) Number:
Align System Device Name:
The Align System is indicated for the treatment of tooth Indications For Use: malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K95.1695
Prescription Use レ
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
27
3
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
198 1098
SUBMITTER INFORMATION 19.1
| a. | Company Name: | Align Technology Inc. | |
|---|---|---|---|
| b. | Company Address: | 2991 El Camino Real, Suite 120 | |
| Redwood City, CA 94061 | |||
| c. | Company Phone: | ||
| Company Fax: | (650) 306-8912 | ||
| (650) 306-8915 | |||
| d. | Contact Person: | Kelsey Wirth | |
| President | |||
| Align Technology Inc. | |||
| e. | Date Summary Prepared: | March 20, 1998 |
19.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | Align System |
|---|---|---|
| b. | Classification Name: | Preformed Tooth Positioner (872.5525) |
IDENTIFICATION OF PREDICATE DEVICE 19.3
| Device | 510(k) No. | Date Cleared |
|---|---|---|
| Great Lakes Orthodontics | ||
| Preformed Tooth Positioner | Class I Exempt | Not Applicable |
| TP Orthodontics Tooth Positioner | K780619 | June 28, 1978 |
| Ortho-Tain Tooth Positioner | Class I Exempt | Not Applicable |
4
DEVICE DESCRIPTION 19.4
Align Technology Inc. (Align) has developed the Align System, which is a series of clear plastic appliances (Aligners) that are intended to replace conventional wire and bracket technology for many orthodontic cases. The series of Aligners moves the patient's teeth in small increments from their original state to a final, treated state. The Align System will use a computer as a tool to assist in creating a series of Aligners that represent sequential movements to generate light and consistent forces on the patient's teeth.
A Dental Practitioner using the Align System diagnoses a patient, determines a treatment plan, and makes dental stone models of a patient's teeth. The Dental Practitioner then sends the molds, along with a prescription for treatment to Align. Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. For each of these intermediate states, a rapid prototyping machine (such as a stereolithography machine) produces corresponding dental molds. In the final step, Align uses a conventional air pressure device (e.g., a Biostar) and commercially available retainer or positioner material (made by Raintree Essix or equivalent) to craft plastic Aligners to fit the developed teeth molds. The models with their corresponding Aligners are then mailed back to the Dental Practitioner. The total number of Aligners can vary from 1 to over 100 per patient, depending on the complexity of the case. The Aligners are individually identified and are dispensed to the patient by the Clinician with specific instructions for use (i.e., the Aligners are to be worn in a prescribed sequence).
5
SUBSTANTIAL EQUIVALENCE 19.5
The Align Technology Inc. Align System is of comparable type and is equivalent to the Preformed Tooth Positioners manufactured by Great Lakes Orthodontics, TP Orthodontics, and Ortho-Tain.
INTENDED USE 19.6
The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.
TECHNOLOGICAL CHARACTERISTICS 19.7
A comparison of the technological characteristics of the predicate and legally marketed devices has been performed. The results of this comparison demonstrate that the Aligners are equivalent to the currently marketed predicate devices.
19.8 PERFORMANCE DATA
Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness.
6
510(K) CHECKLIST 19.9
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist has been provided with this submission.