(70 days)
Not Found
No
The description details a manual fabrication process based on dentist prescriptions and physical models, with no mention of automated design, planning, or analysis that would typically involve AI/ML.
Yes
The device is described as correcting discrepancies in tooth alignment by moving teeth, which is a therapeutic action.
No
Explanation: The provided text describes the Clear Image™ Aligners system as a device intended to correct minor discrepancies in tooth alignment by moving teeth. This is a therapeutic function, not a diagnostic one. The device description details how the aligners are fabricated and how they apply force to reposition teeth, without any mention of identifying or assessing a medical condition.
No
The device description explicitly states that the device is a physical, thermoformed plastic aligner and details its fabrication process and mechanism of action, which involves physical force application.
Based on the provided information, the Clear Image™ Aligners system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Clear Image™ Aligners Function: The Clear Image™ Aligners system is a medical device used to physically move teeth to correct alignment issues. It works by applying mechanical force to the teeth.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. The device is fabricated based on models of the patient's teeth and applied directly to the teeth.
Therefore, the Clear Image™ Aligners system falls under the category of a dental device used for orthodontic treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Clear Image™ Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.
Product codes
NXC
Device Description
Specialty Appliances' Clear Image™ Aligners primarily are directed toward treating a patient's anterior teeth. Such treatment involves the relatively minor orthodonic tooth movements intended to impact a patient's appearance and self image. The aligners are fabricated in clear, thin, thermoformed plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Aligners are fabricated from .035 or .040 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated. Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time.
Specialty Appliances fabricates its aligners from the prescription of an orthodontist or dentist. The dentist selects the teeth to be repositioned and indicates the type of movements desired. The patient's plaster models are then supplied to the laboratory by the attending orthodontist. The model is prepared to allow repositioning the target teeth. Next, an aligner is formed over the master model with the slightly altered to positions. As an aligner with a positionally-biased tooth receiving compartment is seated in the mouth, the positional distance between each compartment and its corresponding living tooth causes a subtle change in the semi-elastic structure of the aligner. In order for a slightly out of register aligner compartment to engage its target tooth, the material surrounding the aligner compartment becomes elastically loaded as if the plastic structure of the aligner were a spring. The subtle pressure of the aligners stored energy acts similar to a spring does when it is loaded. It is the slow dissipation of the stored energy in the structure of the aligner that urges the root structures of the teeth to move through the supportive bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior teeth
Indicated Patient Age Range
patients with permanent dentition (second molars)
Intended User / Care Setting
Orthodontist or dentist / Dental laboratory
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
5. 510(k) Summary
Image /page/0/Picture/1 description: The image shows the text "SPECIALTY APPLIANCES" in a bold, sans-serif font. Below this text, there is a horizontal line, and below the line, the text "ORTHODONTIC LABORATORY SERVICES" is displayed in a smaller, sans-serif font. The text is aligned and centered.
SEP 2 5 2007
510(k) Summary of Safety and Effectiveness
Submitter:
Specialty Appliances Works, Inc. 4905 Hammond Industrial Drive Cumming, GA 30041
Contact:
James W. Kolka P.h.D., J.D. International Legal Consultant 770-977-4049 – Phone 770-977-4049 - Fax
Date Summary Prepared July 2007 Resubmitted September 2007
Device Name:
- Trade Name Clear Image™ Aligners .
- Classification name -- Sequential Aligner .
- Regulation Description -- Orthodontic plastic bracket .
- Definition The device moves by gentle force for treatment of minor tooth . malocclusion
- Regulation Medical Specialty Dental .
- Review Panel Dental .
- Product Code NXC .
- Regulation Number 21 CFR§ 872.5470 .
- Device Class 2 .
Devices for Which Substantial Equivalence is Claimed:
- Align Technologies Align System .
- Allesee Orthodontic Appliances Red, White & Blue .
Device Description:
Specialty Appliances' Clear Image™ Aligners primarily are directed toward treating a patient's anterior teeth. Such treatment involves the relatively minor orthodonic tooth movements intended to impact a patient's appearance and self image. The aligners are
1
ORTHODONTIC LABORATORY SERVICES
fabricated in clear, thin, thermoformed plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Aligners are fabricated from .035 or .040 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated. Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time.
Specialty Appliances fabricates its aligners from the prescription of an orthodontist or dentist. The dentist selects the teeth to be repositioned and indicates the type of movements desired. The patient's plaster models are then supplied to the laboratory by the attending orthodontist. The model is prepared to allow repositioning the target teeth. Next, an aligner is formed over the master model with the slightly altered to positions. As an aligner with a positionally-biased tooth receiving compartment is seated in the mouth, the positional distance between each compartment and its corresponding living tooth causes a subtle change in the semi-elastic structure of the aligner. In order for a slightly out of register aligner compartment to engage its target tooth, the material surrounding the aligner compartment becomes elastically loaded as if the plastic structure of the aligner were a spring. The subtle pressure of the aligners stored energy acts similar to a spring does when it is loaded. It is the slow dissipation of the stored energy in the structure of the aligner that urges the root structures of the teeth to move through the supportive bone.
Intended use of the Device:
The Clear Image™ Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.
Substantial Equivalence:
Clear Image™ Aligners is substantially equivalent to other FDA approved legally marketed orthodontic devices in the United States. Clear Image™ Aligners is used in a manner similar to the Invisalign system, K981095, marketed by Align Technology and Red, White & Blue, K040879, marketed by Allesee Orthodontic Appliances.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Specialty Appliances Works, Incorporated C/O James W. Kolka, Ph.D., J.D. International Legal Consultant 2193 Spear Point Drive Marietta, Georgia 30062
SEP 2 5 2007
Re: K071970
Trade/Device Name: Clear Image" " Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: July 10, 2007 Received: July 17, 2007
Dear Dr. Kolka:
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. 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.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Dr. Kolka
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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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/industry/support/index.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
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Image /page/4/Picture/0 description: The image shows the words "SPECIALTY APPLIANCES" in a large, sans-serif font. Below that, there is a horizontal line, and below the line, the words "ORTHODONTIC LABORATORY SERVICES" are written in a smaller, sans-serif font. The text appears to be a logo or heading for a business that provides orthodontic laboratory services.
Indications for Use
510(k) Number (if known): K071970
Device Name: Clear Image™ Aligners
Indications for Use:
The Clear Image™ Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
AND/OR
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
4905 Hammond Industrial Drive 5 Curi FO - 678-513-4408 · Fax 678-513-7345