(70 days)
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.
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.
The provided text is a 510(k) summary for the Clear Image™ Aligners and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Identification: Trade name, classification, regulation, product code, and device class.
- Predicate Devices: Listing Align Technologies Align System and Allesee Orthodontic Appliances Red, White & Blue for substantial equivalence.
- Device Description: Explaining how the aligners are fabricated from thermoformed plastic, how they apply force to move teeth, and their adjustability and removability.
- Intended Use: Correcting minor discrepancies in maloccluded anterior teeth on patients with permanent dentition through a series of aligners.
- Substantial Equivalence Claim: Stating the device is substantially equivalent to other FDA-approved, legally marketed orthodontic devices (Invisalign and Red, White & Blue).
- FDA Communication: The FDA's letter confirming review of the 510(k) and determination of substantial equivalence, allowing the device to be marketed.
- Indications for Use Statement: Reiterating the intended use for prescription use.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.
§ 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.