(128 days)
No
The description focuses on traditional manufacturing processes (3D printing, vacuum forming) based on a digital plan developed using commercially available software, with no mention of AI/ML in the planning or manufacturing process.
Yes.
The device's intended use is for the alignment of teeth during orthodontic treatment of malocclusions, which is a therapeutic purpose.
No
The device is an aligner used for orthodontic treatment, which is a therapeutic purpose. It does not generate diagnostic information.
No
The device description clearly states that the device is comprised of physical aligner trays made of biocompatible thermoplastic polyurethane, which are manufactured using 3D printing and vacuum forming. While software is used in the planning process, the final medical device delivered to the patient is a physical product.
Based on the provided information, the Pearl Clear Aligner is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Pearl Clear Aligner is used for the physical alignment of teeth in the mouth during orthodontic treatment. It does not involve testing or analyzing any biological samples (like blood, urine, tissue, etc.) taken from the patient.
- The input is a digital scan of the teeth. While this is a form of data, it's a representation of the physical structure of the teeth, not a biological specimen being tested for diagnostic purposes.
- The device is a physical appliance. The description details the materials and manufacturing process of the aligner trays, which are physical devices worn by the patient.
Therefore, the Pearl Clear Aligner falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces.
Product codes
NXC
Device Description
Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental health professional (dentist/orthodontist)
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)
Safety Testing: Testing according to ISO 10993, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management system, was performed by a GLP-certified contract research laboratory: In vitro Cytotoxicity (Part 5) Oral Mucosal Irritation (Part 10) Skin Sensitization (Part 10) Acute Systemic Toxicity (Part 11) Implantation (Part 6) Subacute Systemic Toxicity (Part 11) Subchronic Toxicity (Part 11). Pyrogen Testing was performed according to USP 45/NF40 .
Other Testing: Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans. A final report was part of the 510(k) package. In vivo Animal and Human Clinical performance testing are not required for this device category.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K211510, uLab Systems Dental Aligner Kit, uLab Systems, Inc.
Reference Device(s)
K201036, PlaniMax Orthodontic Software, Choice Biotech Inc.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16th, 2025
Pearl Digital Inc. % Patsv Trisler Regulatory Consultant Pear Digital Inc. 2975 Scott Blvd., Ste 110 Santa Clara, California 95054
Re: K242715
Trade/Device Name: Pearl Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 12, 2024 Received: December 12, 2024
Dear Patsy Trisler:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Pearl Clear Aligner
Indications for Use (Describe)
The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces.
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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Submitter: Pearl Digital, Inc.
Pearl Clear Aligner K242715 Traditional Premarket Notification 510(k) SUBMITTER Name: Pearl Digital, Inc. 2975 Scott Blvd STE 110 Address: Santa Clara, CA 95054 Contact Person: | Henry H. Cao, CEO
| Contact Person: | Henry H. Cao, CEO |
|---|---|
| Email: | henrycao@pearl-digital.com |
| Date Prepared: | December 12, 2024 |
| DEVICE Trade Name: | Pearl Clear Aligners |
| Common Name: | Aligner, Sequential (Clear Braces) |
| Classification Name | Orthodontic Plastic Bracket |
| Number | 21 CFR 872.5470 |
| Product Code | NXC |
| Regulatory Class | 2 |
| Review Panel | Dental |
| PRIMARY PREDICATE: | K211510, uLab Systems Dental Aligner Kit, uLab Systems, Inc. |
| REFERENCE DEVICE: | K201036, PlaniMax Orthodontic Software, Choice Biotech Inc. |
| DEVICE DESCRIPTION | Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function. |
| MECHANISM OF ACTION | Each aligner in the set is used for the specified period of time, usually 1-2 weeks, to exert gentle forces to achieve progressive realignment of the teeth until the planned correction has been achieved. The daily treatment time is approximately 22 hours, or except during eating, based on the clinician's prescribed treatment plan. The aligner trays are held in place by pressure and can be removed by the patients at any time. |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | The thermoplastic polyurethane material used for the |
| manufacture of the Pearl Clear Aligner is similar to the material | |
| used to make the predicate aligners. |
The treatment planning software system used is Choice
Biotech, Inc's. PlaniMax Orthodontic Software, K201036
(Reference device). |
| INDICATIONS FOR
USE STATEMENT | The Pearl Clear Aligner is indicated for the alignment of teeth
during orthodontic treatment of malocclusions by continuous
gentle forces. |
| SAFETY TESTING | Testing according to ISO 10993, Biological evaluation of
medical devices – Part 1: Evaluation and testing within a risk
management system, was performed by a GLP-certified
contract research laboratory:
In vitro Cytotoxicity (Part 5) Oral Mucosal Irritation (Part 10) Skin Sensitization (Part 10) Acute Systemic Toxicity (Part 11) Implantation (Part 6) Subacute Systemic Toxicity (Part 11) Subchronic Toxicity (Part 11) Pyrogen Testing was performed according to USP 45/NF40
. |
| OTHER TESTING | Bench testing was performed to validate the manufacturing
process to ensure the accuracy of the final aligners compared
to the initial digital scans. A final report was part of the 510(k)
package.
In vivo Animal and Human Clinical performance testing are not
required for this device category. |
| COMPARISON TO
THE PREDICATE
DEVICE | The Pearl Digital Aligners device has the same intended use as
the predicate device. The thermoplastic polymer material is
similar and the aligners are designed by commercially available
treatment planning software (Reference Device). The
processes for fabrication of the clear aligners, while proprietary
to each manufacturer, make use of similar, industry-standard
processes using similar machines and materials.
Any differences in the materials, treatment planning software
and specific manufacturing processes do not raise new
questions of safety and effectiveness. |
| SUBSTANTIAL
EQUIVALENCE
CONCLUSION | The information and data provided in this 510(k) establish that
the Pearl Digital Aligners device is substantially equivalent to
the predicate device in the intended use, design, principle of
operation, technology, including use of similar thermoplastic
polymer materials used to make the aligners. See the following
SE Comparison table. |
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6
Submitter: Pearl Digital, Inc.
| 510(k) Number | Proposed Device
K242715 | Predicate #1
K211510 | SE Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name | Pearl Clear Aligner | uLab Systems Dental Aligner
Kit | N/A |
| Manufacturer | Pearl Digital, Inc. | uLab Systems, Inc. | N/A |
| Classification
Regulation | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Name
Product Code
Class | Orthodontic Plastic Bracket
NXC
2 | Orthodontic Plastic Bracket
NXC
2 | |
| Indications for
Use | The Pearl Clear Aligner is
indicated for the alignment of
teeth during orthodontic
treatment of malocclusions by
continuous gentle forces. | The uLab Systems Dental
Aligner is indicated for the
alignment of teeth during
orthodontic treatment of
malocclusions by way of
continuous gentle forces. | Substantially
equivalent
intended use and
Indications for
Use statement |
| Mode of Action | The removable appliance
applies continuous gentle
forces on teeth according to
the plan prescribed by the
doctor. | The removable appliance
applies continuous gentle
forces on teeth according to
the plan prescribed by the
doctor. | Both apply
continuous gentle
forces to achieve
teeth realignment |
| Description of
Use | Each removable preformed
plastic tray, prescribed by the
Dr, is worn by the patient
usually for 1-2 weeks, prior to
using the next sequential
aligner tray according to Dr's
direction. | Each removable preformed
plastic tray, prescribed by the
Dr, is worn by the patient
usually for 1-2 weeks, prior to
using the next sequential
aligner tray according to Dr's
direction. | Wear time per
day and per
sequential set is
similar. |
| Material | Thermoplastic polyurethane | Thermoplastic polyurethane | Both are
thermoplastic
sheets |
| Manufacturing
Process | Forming of plastic sheets on
SD printed dental models
designed with use of the
treatment planning software | Forming of plastic sheets on
SD printed dental models
designed with use of the
treatment planning software | Processes are
different
(proprietary) but
similar and
according to
industry
standards. |
| Software | Commercially available
treatment planning software is
used. | Commercially available
treatment planning software is
used. | Software is
different but both
are commercially
available for
orthodontic
treatment
planning. |
| Prescription Use | Rx | Rx | Both require
prescription. |
| Biocompatibility | Testing to meet requirements
for Category C | Testing to meet requirements
for Category C | Standard ISO
10993 testing
conducted on the
thermoplastic
materials. |
| Process
Validation
Testing | Performed | Performed | Similar testing
performed. |
Substantial Equivalence Comparison Table
7
Submitter: Pearl Digital, Inc.