(471 days)
No
The summary describes a physical device (aligners) and the manufacturing process, with no mention of AI/ML in the device description, intended use, or performance studies. The performance studies focus on physical properties and fit, not algorithmic performance.
Yes
The device is intended to correct discrepancies in the alignment of maloccluded anterior teeth by moving the teeth, which is a therapeutic action.
No
The device is described as a system for correcting teeth alignment, not for identifying or diagnosing a medical condition. Its purpose is therapeutic (to move teeth), not diagnostic.
No
The device description explicitly states it is fabricated of "clear, thin, thermoformed copolyester plastic," indicating it is a physical medical device, not software only.
Based on the provided information, the Krystal Klear Aligners System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Krystal Klear Aligners Function: The Krystal Klear Aligners System is a physical device used to mechanically move teeth. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states the purpose is to "correct minor discrepancies in the alignment of maloccluded anterior teeth" by physically moving them.
- Device Description: The description focuses on the physical properties and fabrication of the aligners.
- Performance Studies: The performance studies described involve bench testing related to the fit and physical properties of the aligners, not the analysis of biological samples.
Therefore, the Krystal Klear Aligners System falls under the category of a medical device used for physical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Krystal Klear 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 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
The Krystal Klear device is fabricated of clear, thin, thermoformed copolyester plastic in a sequential series to progressively reposition teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
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
A dental health care professional (e.g. orthodontist or dentist)
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 was performed to ensure the accuracy of the final product carried through the entire process from the initial scan through treatment planning and manufacturing of the model to the final thermoformed aligner. Functional characteristics tested and the standard by which they were tested include:
- Fit of the aligner against the treatment plan as determined by dental health professional
- Process consistency from the treatment plan file to 3D printed mold to final aligner was measured against internal acceptance criteria derived by considering all sources of variation
Additional physical attributes tested and met acceptance criteria:
- Density (ASTM Method D1505)
- Flexural Modulus (ASTM Method D790)
- Flexural Strength (ASTM Method D790)
- Tensile Strength (ASTM Method D882)
- Tensile Modulus of Elasticity (ASTM Method D882)
Biocompatibility testing was conducted in accordance with US FDA Docket Number FDA-2013-D-0350, "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process – Guidance for Industry and Food and Drug Administration Staff", for mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included:
- Cytotoxicity
- Sensitization
- Irritation
The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant.
Software testing has been performed to verify the safety and effectiveness of the Krystal Klear Aligner System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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December 19, 2019
Shatkin F.I.R.S.T. LLC Kimberly Wiesmore Controller 2495 Kensington Avenue Amherst, New York 14226
Re: K182388
Trade/Device Name: Krystal Klear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 18, 2019 Received: November 19, 2019
Dear Kimberly Wiesmore:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K182388
Device Name Krystal Klear Aligners System
Indications for Use (Describe)
The Krystal Klear 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 teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.
| 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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510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21CFR 807.92.
| Submitter: | Shatkin F.I.R.ST. LLC
2494 Kensington Avenue
Amherst, NY 14226
Not Currently FDA Registered |
|-------------------------|------------------------------------------------------------------------------------------------------|
| Primary Contact: | Kimberley Wiesmore, CFO
Phone: 716.839.2959 x 149
kwiesmore@shatkinfirst.com |
| Secondary Contact: | Todd Shatkin, DDS
Phone: 716.839.2959 |
| Date Prepared: | 26 August 2018 (Original)
10 November 2019 (Revised) |
| Proprietary Trade Name: | Krystal Klear Aligner System |
| Device Name: | Sequential Aligner |
| Common Name: | Clear Braces / Aligners |
| Classification Name: | Orthodontic Plastic Bracket |
| Regulation Number: | 852.5470 |
| Product Code: | NXC |
| Classification Panel: | Dental Products Panel 76 |
| Classification: | Medical Device, Class II |
Predicate Devices:
Clear Image Aligners, Specialty Appliance Works, K071970 (Primary Predicate) Clear Correct, Clear Correct Inc., K082556 (Reference Device) Invisalign, Align Technology, K981095 (Reference Device)
Device Description:
The Krystal Klear device is fabricated of clear, thin, thermoformed copolyester plastic in a sequential series to progressively reposition teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
4
Indications for Use:
The Krystal Klear 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 teeth over a period of several months. The aligners are completely removeable by the patient and may be discontinued at any time.
Technological Characteristics:
Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves teeth to a desired end-state is the technological principle for both the subject and predicate devices. A comparison between technological characteristics of the Krystal Klear Aligner System and that of legally marketed predicate devices has been performed. The results of this comparison demonstrate that the design, technology, materials, and composition of the Krystal Klear Aligner System are substantially equivalent to the predicate devices.
A dental health care professional (e.g. orthodontist or dentist), prescribes the Krystal Klear Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. The molds and prescription are created by Krystal Klear. Utilizing standard dental software used for tooth alignment, Masterpieces (MAP) then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, MAP produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1 below.
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Mechanism of Action:
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
Performance Testing:
Bench testing was performed to ensure the accuracy of the final product carried through the entire process from the initial scan through treatment planning and manufacturing of the model to the final thermoformed aligner. Functional characteristics tested and the standard by which they were tested include the following, all pre-established specifications and acceptance criteria:
- Fit of the aligner against the treatment plan as determined by dental health . professional
- Process consistency from the treatment plan file to 3D printed mold to final . aligner was measured against internal acceptance criteria derived by considering all sources of variation
The acceptable results observed during the verification and validation testing that has been conducted on these devices has shown that they are capable of performing to their stated intended use and specification requirements.
Additional physical attributes tested, and the standard by which they were tested are below, which met acceptance criteria:
| Attribute | ASTM Method |
|---|---|
| Density | D1505 |
| Flexural Modulus | D790 |
| Flexural Strength | D790 |
| Tensile Strength | D882 |
| Tensile Modulus of | |
| Elasticity | D882 |
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Further testing was not performed given there is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of safety and effectiveness.
Biocompatibility Testing:
The biological evaluation for the device was conducted in accordance with the US FDA Docket Number FDA-2013-D-0350, "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process – Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant. The results of the studies further support the determination of substantial equivalence.
Software Consideration
There are two areas in the Krystal Klear Aligner System process where software is used; they are the ordering process and treatment planning. The software usage in these areas is considered of moderate concern. Software testing has been performed to verify the safety and effectiveness of the Krystal Klear Aligner System, which supports a substantial equivalence decision.
Substantial Equivalence Comparison:
The following table compares the Krystal Klear Aligner System to the predicate devices, Clear Image Aligners (primary predicate), and Clear Correct (reference device) & the Align System (reference device), with respect to intended use, technological characteristics, and principles of operation.
The aligner has the same patient contact, similar materials, and the same manufacturing processes as the legally marketed device on the market. As the material is slightly different, biocompatibility testing was performed to verify safety and effectiveness for the Krystal Klear Aligner system.
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Table 1. Predicate Device Information Comparison
| | KrystalKlear
(Submission
Device) | Clear Image
Aligners
(Primary Predicate) | Clear Correct
(Reference Device) | Invisalign/Align
System
(Reference Device) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | (Submission
Device) | (Primary Predicate) | (Reference Device) | (Reference Device) |
| 510(k) Number | K182388 | K071970 | K082556 | K981095 |
| Classification
Number & Product
Code | 852.5470
NXC | 852.5470
NXC | 852.5470
NXC | 852.5470
NXC |
| Indications for Use | The Krystal Klear
System is intended to
correct minor
discrepancies in the
alignment of
maloccluded teeth on
patients with
permanent dentition
(second molars) by
moving the teeth with
a progressive series
of thermoformed
plastic aligners,
fabricated in stages
to gradually align
teeth over a period of
several months. The
aligners are
completely removable
by the patient and
may be discontinued
at any time. | The Clear Image TM
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 teeth over a
period of several
months. The aligners
are completely
removable by the
patient and may be
discontinued at any
time. | The ClearCorrect
System is indicated
for the treatment of
tooth malocclusion in
patients with
permanent dentition
(i.e. all second
molars). The
ClearCorrect System
positions teeth by
way of continuous
gentle force. | 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. |
| Mode of Action | Alignment of teeth by
sequential use of
preformed plastic
trays. | Alignment of teeth by
sequential use of
preformed plastic
trays. | Alignment of teeth by
sequential use of
preformed plastic
trays. | Alignment of teeth by
sequential use of
preformed plastic
trays. |
| Material | Thermoformed
Copolyester | Thermoformed
Polycarbonate | Thermoformed
Polycarbonate | Thermoformed
Polycarbonate |
| OTC or Rx | Rx | Rx | Rx | Rx |
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Substantial Equivalence Conclusion:
The conclusion drawn from the data included in this submission demonstrates that the Krystal Klear Aligner System is as safe, effective, and substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials, and biocompatibility.