(112 days)
No
The description details a standard dental curing light with fixed operational modes and no mention of adaptive or learning capabilities.
Yes
The device is a dental curing light used for light curing polymerization of dental materials, which is a therapeutic intervention to harden the material.
No
This device is a dental curing light used for the polymerization of dental materials, not for diagnosing medical conditions. It delivers light energy to induce a chemical reaction (curing) in dental materials.
No
The device description clearly outlines multiple hardware components including a handpiece, battery, laser diode, optical fiber, cure tips, and a charging stand. While there is likely software controlling the operation modes and user interface, the device is fundamentally a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "light curing polymerization of small areas of dental materials." This describes a process performed on dental materials, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The device description details a dental curing light that uses light energy to polymerize dental materials. It does not mention any components or functions related to analyzing biological samples.
- Lack of Biological Sample Interaction: The device interacts with dental materials, not with human or animal biological specimens (like blood, urine, tissue, etc.) which are the basis of IVD testing.
- Performance Studies: The performance studies focus on the device's ability to cure dental materials effectively, measuring parameters like irradiance, peak wavelength, and depth of cure. These are not typical performance metrics for IVD devices, which would focus on analytical and clinical performance related to biological samples.
- Predicate and Reference Devices: The predicate and reference devices are also dental curing lights, further indicating that this device falls within the category of dental equipment, not IVDs.
In summary, IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to cure dental materials, which is a therapeutic or restorative process, not a diagnostic one.
N/A
Intended Use / Indications for Use
For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
Product codes (comma separated list FDA assigned to the subject device)
QNF
Device Description
Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.
Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.
Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professionals
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)
Non-clinical performance testing was conducted according to FDA guidance "Dental Curing Lights - Premarket Notification [510(k)] Submissions," issued March 27, 2006, and recognized consensus standard ISO 10650:2018 (FDA recognition #4-252).
Inspection of connections and operating controls was carried out according to ISO 10650:2018, chapter 7.2.1 and 7.2.2. Irradiance, peak wavelength and depth of cure were measured according to the FDA guidance and ISO 4049:2009, chapter 7.10. Irradiance and depth of cure were compared between the subject and the predicate and reference device.
Fibercure meets the requirements of ISO10650:2018 and the FDA guidance "Dental Curing Lights – Premarket Notification [510(k)] Submissions". The determined performance parameters are compatible with the requirements for the intended use and are comparable to those of the predicate device.
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.
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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 2, 2023
Lumendo AG Mark Bispinghoff Coo Chemin du Closel 5 Renens, VD 1020 Switzerland
Re: K232076
Trade/Device Name: Fibercure Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: QNF Dated: October 4, 2023 Received: October 4, 2023
Dear Mark Bispinghoff:
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" (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).
1
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).
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 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-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 Shirmohamma વા -ડ
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Fibercure
Indications for Use (Describe)
For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
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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Prepared on: 2023-10-31
510(k) Summary K232076
This 510(k) summary information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant 1
| NAME: | Lumendo AG |
|---|---|
| ADDRESS: | Chemin du Closel 5, 1020 Renens (VD), Switzerland |
| CONTACT PERSON: | Dr. Mark Bispinghoff |
| CONTACT DETAILS | +41 44 589 68 02, mark.bispinghoff@lumendo.ch |
Device 2
| DEVICE NAME: | Fibercure |
|---|---|
| COMMON NAME: | Ultraviolet activator for polymerization |
| CLASSIFICATION NAME: | Laser activator for polymerization |
| REGULATION NUMBER: | 872.6070 |
| PRODUCT CODE: | QNF |
Legally marketed predicate devices 3
| DEVICE TYPE | 510(K) # | PREDICATE TRADE NAME | PRODUCT CODE |
|---|---|---|---|
| PRIMARY PREDICATE | K220826 | LED Curing light DB686 nano | EBZ |
| REFERENCE | K201904 | Ultraviolet activator for polymerization | QNF |
Device description summary 4
Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.
Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.
Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
5
Indications for Use 5
For light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range.
Indications for Use Comparison 6
The subject device, Fibercure, is indicated for light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range. The predicate device is indicated for light curing polymerization of dental composites, luting materials, cements and other light cured materials. While the subject device refers to the photocuring of dental materials in general, the predicate lists examples of such materials but also includes "other light cured materials" which encompasses the general, dental materials referenced by the subject device. This difference, along with specification of the compatible wavelength range, does not result in a new intended use because both result in an intended use for photo-curing of dental materials.
Substantial Equivalence Comparison 7
Fibercure and the predicate device have the same type of use, treatment site, mechanism of action, components, power source, electrical safety classification, operational modes, infection control for the handpiece, and user interface. Where there are differences between Fibercure and the predicate device, they do not raise different questions of safety of effectiveness. The performance testing results demonstrate that Fibercure functions as intended.
The characteristics of the subject and predicate devices are tabulated and compared below:
6
| Device | Subject device
Fibercure | Predicate device
LED Curing light DB686 nano
(K220826) | Reference device
Monet Curing Laser
(K201904) | Comparison |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Photocuring of dental materials | Photocuring of dental materials | Photocuring of dental materials | Identical |
| Indications for
use | For light curing polymerization of
small areas of dental materials capa-
ble of curing in the 385 - 425 nm
wavelength range | For light curing polymerization of
dental composites, luting materials,
cements and other light cured mate-
rials. | The Monet Curing Laser is a source
of illumination for curing photo-ac-
tivated dental restorative materials
and adhesives. | Similar: The subject device is intended
for photocuring of dental materials in
the 385 - 425 nm wavelength range
only. |
| Type of use | Prescription use | Prescription use | Prescription use | Identical |
| Target users | Dental Professionals | Dental Professionals | Dental Professionals | Identical |
| Treatment site | Oral cavity | Oral cavity | Oral cavity | Identical |
| Mechanism of
action | Light irradiation of dental material | Light irradiation of dental material | Light irradiation of dental material | Identical |
| Handling instruc-
tions | 1. Clean and disinfect all the sur-
faces of the handpiece before
each use.
2. Attach a cure tip to the device.
3. Cover the handpiece with the dis-
posable Protective Sleeve.
4. Power on the device by pressing
the power button.
5. Press the Laser button to acti-
vate the light. Press once or
twice to select curing time.
6. Once the selected curing time has
elapsed, the curing program is
automatically terminated. | 1. Clean and disinfect all the sur-
faces of the handpiece and the
cure tip before each use.
2. Attach the cure tip to the device.
3. Cover the device with the dis-
posable Protective Sleeve.
4. Operate the rotary switch to
Cure to power on the device.
5. Press the Start key to activate
the light. Press once or twice to
select curing time.
6. Once the selected curing time
has elapsed, the curing program
is automatically terminated. | 1 . Disinfect the unit before each use.
2. Ensure a charged battery is at-
tached to the unit and a barrier
sleeve is applied.
3. Press the switch to "wake up" the
unit and go to Standby status.
4. Press the switch to go to enter the
"Ready" status
5. Press the switch to activate the la-
ser for 1 second. | Similar: The subject and the predicate
and reference all include steps for dis-
infection, tip attachment, covering
with a protective barrier sleeve, and
device activation by operating a
switch. |
| Device | Subject device
Fibercure | Predicate device
LED Curing light DB686 nano
(K220826) | Reference device
Monet Curing Laser
(K201904) | Comparison |
| Components | Handpiece, charging base with
power meter, cure tip, battery,
adapter with power cord, protective
sleeve, user manual | Handpiece, charging base with
power meter, cure tip, battery,
adapter with power cord, protective
sleeve, user manual | Handpiece, charging base with
power meter, battery, adapter with
power cord, protective sleeve, user
manual | Identical |
| FDA-Recognized
Standards | IEC 80601-2-60:2019 (Rec.# 4-262)
IEC 60601-1:2020 (Rec.# 19-49)
IEC 60601-1-2:2020 (Rec.# 19-39)
IEC 60825-1:2014
ISO 7405:2018 (Rec.# 4-261)
ISO 10993-1:2018 (Rec.# 2-258) | IEC 80601-2-60
IEC 60601-1
IEC 60601-1-2
IEC 62471 | IEC 60601-1:2012
IEC 60601-1-2:2020 (Rec.# 19-39)
IEC 60825-1:2007 (Rec.# 12-273) | Similar: Electrical safety, EMC, laser
safety, and biocompatibility of the sub-
ject device was tested according to the
currently FDA-recognized consensus
standards. |
| Power source | User-replaceable battery | User-replaceable battery | User-replaceable battery | Identical |
| Charging power
supply | Input: 100 – 240 V, 50 – 60 Hz
Output: 5 V, 1.2 A | Input: 100 – 240 V, 50 – 60 Hz
Output: 5 V, 1.5 A | Input: 100 - 240 V, 50 - 60 Hz
Output: 5 V, 2 A | Similar: the subject, predicate, and ref-
erence devices have identical input
voltage and frequency and identical
output voltage. The subject device has
a slightly lower output current. |
| Electrical safety
classification
(IEC 60601-1) | Class II, Type B Applied Part | Class II, Type B Applied Part | Class II, Type B Applied Part | Identical |
| Light source &
Laser safety class
(IEC 60825-1) | Laser diode, class 3R | Light-emitting diode (LED) | Laser diode, class 4 | Similar: the internal light sources
within the handpiece are different, but
the light exits the device via a light
guide in all cases. |
| Irradiance
(at 2 mm distance
from the tip) | 1800 - 2200 mW/cm2 | 1600 - 1800 mW/cm2 | 2000 - 2400 mW/cm2 | Similar: The irradiance of the subject
device is between the predicate and
reference device. |
| Device | Subject device
Fibercure | Predicate device
LED Curing light DB686 nano
(K220826) | Reference device
Monet Curing Laser
(K201904) | Comparison |
| Peak wavelength | $405 \pm 5$ nm | 405 nm, 460 nm | 450 nm | Similar: The peak wavelength of the
subject device is the same as one of the
peak wavelengths of the predicate de
vice. |
| Depth of cure | $1.4 \pm 0.1$ mm | $1.7 \pm 0.1$ mm | $2.1 \pm 0.1$ mm | Similar: all devices pass the
ISO 4049:2019, clause 5.2.8 require
ment of ≥ 1 mm for class 2, opaque re
storative materials. |
| Operational
modes | 10 seconds, 20 seconds | 10 seconds, 20 seconds | 1, 2, or 3 s | Identical (subject & predicate device) |
| Infection control
(Handpiece) | Intermediate/ low-level surface dis-
infection
Use of protective barrier sleeve | Intermediate/ low-level surface dis-
infection
Use of protective barrier sleeve | Intermediate/ low-level surface dis-
infection
Use of protective barrier sleeve | Identical |
| Infection control
(Cure Tip) | Single-use | Reusable
Intermediate/low-level disinfection | Reusable
Intermediate/ low-level disinfection | Similar: all devices include infection
control mechanisms for the Cure Tip.
The subject device features a single-
use cure tip, whereas the predicate and
reference devices feature reusable tips
that require intermediate/ low-level
disinfection. |
| Dimensions (cm) | 205 x 18 mm | 197 x 13.5 mm | 215 x 19 mm | Similar: the dimensions of the subject
device lie between those of the predi-
cate and the reference device. |
| User interface | 2 Buttons with indicator lights | 2 Buttons with indicator lights | 1 Button | Identical (subject & predicate device) |
7
8
9
Non-Clinical Tests Summary 8
Non-clinical performance testing was conducted according to FDA guidance "Dental Curing Lights - Premarket Notification [510(k)] Submissions," issued March 27, 2006, and recognized consensus standard ISO 10650:2018 (FDA recognition #4-252).
Inspection of connections and operating controls was carried out according to ISO 10650:2018, chapter 7.2.1 and 7.2.2. Irradiance, peak wavelength and depth of cure were measured according to the FDA guidance and ISO 4049:2009, chapter 7.10. Irradiance and depth of cure were compared between the subject and the predicate and reference device.
Fibercure meets the requirements of ISO10650:2018 and the FDA guidance "Dental Curing Lights – Premarket Notification [510(k)] Submissions". The determined performance parameters are compatible with the requirements for the intended use and are comparable to those of the predicate device.
Conclusion 9
In conclusion, Fibercure meets the requirements of the applicable standard and guidance, performs as specified and is as safe and effective for its intended use as the predicate device. The Fibercure device shares an identical intended use, and similar indications for use with the predicate device. Fibercure and the predicate device also have the same type of use, target users, treatment site, mechanism of action, components, power source, electrical safety classification, operational modes, infection control for the handpiece, and user interface.
Therefore, the Fibercure device is substantially equivalent to the listed predicate device without raising any different questions of safety or effectiveness.