(370 days)
Not Found
No
The summary describes a standard dental curing light and does not mention any AI or ML capabilities.
No.
This device is used to polymerize dental materials, not to treat a disease or condition in a patient.
No
The device is a curing light used to polymerize dental materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "Curing Light" which "generates high intensity light," indicating it is a hardware device that emits light for polymerization, not solely software.
Based on the provided information, the MaxCure9 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials". This is a therapeutic/restorative function performed directly on the patient's teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces this by stating it "generates high intensity light for polymerization of light curing materials used for dental curing purpose" and is used "to restore teeth".
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
The MaxCure9 is a dental curing light, which is a medical device used in the treatment of dental conditions.
N/A
Intended Use / Indications for Use
The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.
Product codes
EBZ
Device Description
This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals / Hospital
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
Biocompatibility testing was conducted because although the device does not come in contact with oral tissue on the chance that contact does occur.
The biocompatibility evaluation for the Curing light was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytoxicity
- Skin Sensitization
- Oral Mucosa Irritation
Software Validation:
The Curing light software has been fully validated and the device software meets its Design Specifications. FDA Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices has been followed in connection with the design of the device.
Non-clinical data:
The Curing light has been tested according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units
Clinical data:
The subject of this premarket submission, Curing light, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(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.
November 15, 2023
Guilin Refine Medical Instrument Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K223414
Trade/Device Name: Curing Light, Model: MaxCure 9 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: August 14, 2023 Received: August 15, 2023
Dear Kevin Wang:
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.
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
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 OS 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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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.
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 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.
Bobak Shirmoham madi -S
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and
2
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223414
Device Name Curing Light, Model: MaxCure 9
Indications for Use (Describe)
The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515mm waveband of visible light.
| Type of Use (Select one or both, as applicable) |
|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2023/11/9
1. Submission sponsor
Name: Guilin Refine Medical Instrument Co., Ltd.
Address: No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, GuangXi, China 541004
Contact person: Chen Judong
Title: Management Representative
E-mail: chenjudong(@refine-med.com
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Curing Light, Model: MaxCure 9 |
|---|---|
| Model | MaxCure9 |
| Common Name | Curing Light |
| Regulatory Class | Class II |
| Classification | 21 CFR 872.6070 / Activator, Ultraviolet, For Polymerization / EBZ |
| Submission type | Traditional 510(K) |
3 Subiect Device Information
4. Predicate Device
-
- Diadent Group International, D-Lux+ under K200809 (Primary predicate)
Device Description ട്.
This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.
Intended use & Indication for use 6.
The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.
Section 5 510(k) Summary
5
| Features | Predicate device
D-Lux+ | Subject device
Curing Light, Model:
MaxCure 9 (K223414) | Note |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K200809 | \ | Same |
| Product code | EBZ | EBZ | Same |
| Intended Use &
Indications for
use | The D-Lux+ is intended to
polymerize resinous dental
materials, restorative composite
materials, and orthodontic
brackets, bonding and sealing
materials that are photo-
polymerized in the 385515nm515nm waveband of
waveband of visible light. | The MaxCure9 is intended
to polymerize resinous
dental materials, restorative
composite materials, and
orthodontic brackets,
bonding and sealing
materials that are photo-
polymerized in the
385
visible light. | Same |
| Principles of
operation | 1. Insert the Light Probe into the
handpiece. Attach the Light
Protector to the handpiece.
2. Cover the Light Probe with the
Disposable Sheath.
3. Turn on the power and select
the mode and set-up time.
4. Press the Operation button to
perform light irradiation for the
set time and press the button
once again to stop the light
irradiation. The light irradiation
progress time is displayed
numerically in the display
window. | a) Insert the light guide into
the mounting hole of the
curing light. Clamp and
install the light hood at the
root of the light guide.
b) Cover the Light Guide
with the disposable isolation
sleeve.
c)Turn on the power and
select the mode and set-up
time.
d) Press the mode key to
perform light irradiation for
the set time and press the
button once again to stop
the light irradiation. | Same |
| Delivery form | -D-Lux+ Handpiece
-D-Lux+ Charger
-Light Probe
-Light Protector
-C-Battery (Included in the
handpiece)
-Adapter
-Power Cord
-Disposable Sheaths(200ea/Box) | Main unit,
Charger,
Light hood,
Power adapter,
disposable PE isolation
sleeve (100ea/Box),
Instruction Manual. | Same |
| Features | Predicate device
D-Lux+ | Subject device
Curing Light, Model:
MaxCure 9 | Note |
| | -User Manual | | |
| Technical
Specifications –
Wavelength
range | 385 – 515 nm | 385 – 515 nm | Same |
| Peak
wavelength | Dual peak:
405nm, 460nm | Dual peak:
400nm, 452 nm | SE, The
values are
similar. This
difference
does not
raise issues
of
substantial
equivalence. |
| Depth of cure | ≥2mm | ≥2mm | Same |
| Light
source/Probe | a light probe with an embedded
LED | a light probe with an
embedded LED | Same |
| Operation
Modes and
Light Intensity | 5 modes:
STD (Standard) mode :900 mW/cm²,
5, 10, 15 and 20 seconds
SFT (Soft Start) mode: 1,300
mW/cm²,
10 and 15 seconds
HIG (High Power) mode: 1,300
mW/cm²,
5, 10 and 15 seconds
ORT (Orthodontic) mode: 1,800
mW/cm²,
3, 4, 5 seconds and P
MAX (Max Power) mode:2,400
mW/cm²,
1, 2 and 3 seconds | 2 modes:
Turbo mode: 2000 mW/cm2,
1S, 3S
Normal mode: 1000
mW/cm2,
5S, 10S, 15S, 20S | Different 1 |
| Cross Infection
Prevent | disposable sheath | disposable PE isolation
sleeve | Same |
| Use | Prescription / Hospital | Prescription / Hospital | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Power Source | rechargeable lithium ion battery | rechargeable lithium ion | Same |
| Features | Predicate device
D-Lux+ | Subject device
Curing Light, Model:
MaxCure 9 | Note |
| Battery
Charging | wirelessly charged | charging method by the
contact | Different 2 |
| Power supply | 100-240VAC, 50-60Hz | 100V-240V AC 50Hz/60Hz | Same |
| outputs | 6VDC/2A | DC 5V/1A | Different 2 |
| Electrical Safety | IEC60601-1 and IEC 60601-1-1-
2 | IEC60601-1 and IEC
60601-1-1-2 | Same |
| Chemical
composition of
patient
contacting
portions of the
device | N/A | PE | Different 3 |
| Biocompatibility | Direct contact with issue in not
intended. Therefore ISO10993-1
is not applicable | ISO 10993-5
ISO 10993-10 | Different 3 |
7. Comparison to the Predicate Device
6
7
Different (1): Operation Modes and Light Intensity
The subject device has several modes corresponding to the light output intensity and available times. The light output safety and performance test was conducted according to IEC 60601-1, IEC60601-1-2 and FDA guidance performance testing requirements with the difference. The testing results show that these differences do not affect safety and effectiveness .
Different (2): Battery Charging and Power Supply
The subject device is charged by the charging method of contact. However, the predicate device is wirelessly charged without a contact using a wireless charger. As a power source for the charger, the AC/DC adapter provided by the manufacturer is used. The input specifications of the adapter(100-240VAC, 50-60Hz) are the same, but the outputs differ from each other at 5VDC/1A and 6VDC/2A respectively. These differences do not affect safety and effectiveness . Different (3): Biocompatibility
Biocompatibility testing of the subject device was conducted because although the device does not come in contact with oral tissue on the chance that contact does occur. However, the predicate device is not evaluated. The testing results show that these differences do not affect safety and effectiveness.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility testing was conducted because although the device does not come in contact with oral tissue on the chance that contact does occur.
The biocompatibility evaluation for the Curing light was conducted in accordance with the FDA Guidance Section 5 510(k) Summary 5- 5 / 6
8
for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytoxicity
- Skin Sensitization
- Oral Mucosa Irritation
Software Validation
The Curing light software has been fully validated and the device software meets its Design Specifications. FDA Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices has been followed in connection with the design of the device.
Non-clinical data
The Curing light has been tested according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units
Clinical data
The subject of this premarket submission, Curing light, did not require clinical studies to support substantial equivalence.
9. Conclusion
Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, the subject Curing light is considered to be substantially equivalent to the predicate device.