(90 days)
Not Found
No
The device uses a "coaxial feedback sensing system" and "closed loop" operation to make "corrective adjustments" to LED power based on measured irradiance. While this involves feedback and adjustments, it describes a control system based on direct measurement and pre-programmed logic, not learning or complex pattern recognition characteristic of AI/ML. The summary does not mention any AI/ML terms, training data, or performance metrics typically associated with AI/ML devices.
No.
The device cures dental materials, which is a restorative process, not a therapeutic one that treats a disease or condition.
No
Explanation: The device description clearly states its purpose is "for polymerization of dental materials" and that it functions as a "source of illumination for curing photo-activated dental restorative materials and adhesives." There is no mention of it being used to detect, identify, or determine the presence or absence of a disease or condition. While it has a feedback system, this is for adjusting its own performance in curing materials, not for diagnostic purposes.
No
The device description explicitly states that LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station, which are hardware components. The performance studies also include extensive mechanical and engineering testing of these hardware components.
Based on the provided information, the LOOP™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cure photo-activated dental materials and adhesives. This is a therapeutic/restorative function performed directly on the patient's tooth.
- Device Description: The description focuses on the light source and its function in polymerizing dental materials. It's a medical electrical device used by dental professionals.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The LOOP™ does not interact with or analyze such specimens.
- Performance Studies: The performance studies listed are related to the device's safety, electrical properties, software, mechanical durability, and light output characteristics – all relevant to a medical device used in a clinical setting, but not indicative of IVD testing.
In summary, the LOOP™ is a medical device used for a dental procedure, not for in vitro diagnostic testing of biological specimens.
N/A
Intended Use / Indications for Use
Indications for Use: LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2.
LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.
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
Dentist or dental professional
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)
Biocompatibility Testing: Garrison Dental conducted cytotoxicity, hypersensitivity and reactivity biocompatibility testing. The biocompatibility evaluation of the LOOP was conducted in accordance with ISO 10993-5:2009 and ISO 10993-10:2010. The battery of testing included Cytotoxicity - MEM Elution Test, Maximization Test for Delayed-Type Hypersensitivity in Hartley Guinea Pigs, and Intracutaneous (Intradermal) Reactivity Test in New Zealand White Rabbits. Testing concluded that the test article did not have a cytotoxic effect, did not elicit sensitization and not elicit biologically significant irritation reactions.
Electromagnetic Compatibility (EMC) and Electrical Safety: Electrical safety and EMC testing were conducted on the LoOP and the Lithium-Ion battery. The system complies with IEC 60601-1, IEC 60601-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60101-2-57, IEC 62133, IEC 62471, and IEC 60601-1 Clause 8.
Software Verification and Validation Testing: Software verification and validation testing were conducted. The software for the LOOP was considered as a "moderate" level of concern.
Mechanical and Engineering Testing: Tests performed include S-LED Design Verification and Plan Report, Vibration, Shock and Environmental Test, 3-year wand lifecycle durability verification, 3-year durability test report, Clinicians Report - results of in-house evaluation of LOOP prototype, Long Term Battery Test, Characterization of Curing Light Tips, Beam Analysis, LOOP IFU Spectrum Generation, ISO 10650-2: 2018 Powered Polymerization Activators, Drop and Ingress Testing, Tip Rotation Life Test, Top Arm Lift Test and Calibration Reliability Test, Pin Connection Reliability Test, Test IFU Recommended Cleaning Solutions on CLCL and Accessories, Evaluation of Lens Hardness, Testing Production Barrier Sleeve Effects on CLCL Wand, Functional Thermal Humidity, Reflectance Variation Testing, Material Compare for RevJ BSleeve, Testing Irradiance Penetration from composites, Light Shield Effects on Reflectance Measurements, MARC-LC Certification, GDS-CLCL-2 Irrad Calibration, CLCL-5 MARC Correlation, Centroid Device Tolerance Template, Optical Inspection, Re-Testing the CLCL Shield for light blocking effectiveness, UL746CReview, Testing CLCL reflectance detection of angled surfaces, Turn on/off Distances of LOOP during In Vivo use, Testing Auto Start Distances on Human Tissue, Testing CLCL function over various dental materials, CLCL Benchmark Irradiance Output at various distances, Service Battery, CLCL Mechanical Attribute Examination, Touch Temp Verification, Elect Leakage and Dielectric.
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.
August 1, 2024
Garrison Dental Solutions, LLC % Michael Tomasovich Sr. Regulatory Specialist/Manager Regulatory Affairs Associates, LLC 4761 Tara Court West Bloomfield, Michigan 48323
Re: K241238
Trade/Device Name: LOOP™ LED Curing Light System (CLK01) Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: May 2, 2024 Received: May 3, 2024
Dear Michael Tomasovich:
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/cdrb/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 (OS) 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.
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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, 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
510(k) Number (if known) K241238
Device Name LOOP™ LED Curing Light System
Indications for Use (Describe)
Indications for Use: LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.
| Type of Use (Select one or both, as applicable) |
|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Section 02 510(k) Summary (K241238)
[as required by section 807.92(c)]
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
I. Submitter
| Submitted by: | Garrison Dental Solutions, LLC
150 DeWitt Lane
Spring Lake, MI 49456 USA
Phone: 1-616-743-2244 x278
Email: rallen@garrisondental.com |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Tomasovich, MS RAC
Regulatory Affairs Associates, LLC
4761 Tara Court
West Bloomfield, MI 48323 USA
Phone: 734-788-3480
Fax: 313-557-4200
Email: mtomasovich@regaffairs.net |
| Date Prepared: | May 2, 2024 |
II. Device
| Trade Name: | LOOPTM LED Curing Light System |
|---|---|
| Common Name: | Activator, ultraviolet for polymerization |
| Model: | CLK01 |
| Regulation: | 21 CFR §872.6070 |
| Regulatory Class: | II |
| Product Code: | EBZ |
| Classification Name: | Ultraviolet activator for polymerization |
| Review Panel: | Dental |
III. Predicate Device (Primary Predicate)
| Trade Name: | LOOP™ LED Curing Light System (rev H) |
|---|---|
| Manufacturer: | Garrison Dental Solutions, LLC |
| Common Name: | Activator, ultraviolet for polymerization |
| Model: | CLK01 |
| Regulation: | 21 CFR §872.6070 |
5
| Regulatory Class: | II |
|---|---|
| Product Code: | EBZ |
| 510K Number: | K200775 |
| Classification Name: | Ultraviolet activator for polymerization |
| Review Panel: | Dental |
IV. Device Description
LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2.
LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.
V. Indication
The LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.
VI. Comparison to Predicate Device
The proposed device, LOOP™ LED Curing Light System (rev K), is a source of illumination for curing photo-activated dental restorative materials and adhesives which has the same intended uses as the proposed predicate device, the LOOP™ LED Curing Light System (rev K, K200775).
Both devices are battery powered hand-held devices to be used by dentists or dental professionals that also come with AC power supply wall chargers. Power outputs for both devices range from 1000-3000 mW/cm2. Both devices use LED light in blue and violet wavelengths with light head diameters of 9.7mm.
Both products come with protective barrier sleeves.
6
The predicate device has a housing made of cast aluminum. The current device has a housing made of injection molded plastic resin.
| Name | LOOP™ LED Curing
Light System (Rev K) | LOOP™ LED Curing
Light System (Rev H) | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510(k) Number | To be determined | K200775 | |
| Applicant | Garrison Dental Solutions | Garrison Dental Solutions | Same |
| Common Name | Activator, ultraviolet for
polymerization | Activator, ultraviolet for
polymerization | Same |
| Classification Name | Ultraviolet activator for
polymerization | Ultraviolet activator for
polymerization | Same |
| Regulation | 21 CFR §872.6070 | 21 CFR §872.6070 | Same |
| Product Code | EBZ | EBZ | Same |
| Intended Use | The LOOP is a source of
illumination for curing photo-
activated dental restorative
materials and adhesives. | The LOOP is a source of
illumination for curing
photo-activated dental
restorative materials and
adhesives. | Same |
| Intended User | Dentist or dental professional | Dentist or dental professional | Same |
| Power source | Batteries: Lithium Ion 18650
with a working voltage of 3.7
VDC
Safety rating: IEC 62133,
RoHS, WEEE
Power Charger: 4.2VDC
Lithium Ion smart battery
charger
AC Power Supply: Connects
to charger, wall powered.
Output: 5VDC, 2A.
Input: 100VAC – 240VAC
with adapters for international
capability.
Ratings:
Medical Grade, IEC 60601-1,
IEC 60601-1-11, IEC 60601-
1-2, CE, RoHS, WEEE
Cord: 4 ft (1.2m), 2.5mm DC
connector
Power On Button: Located
on the handle of wand | Batteries: Lithium Ion 18650
with a working voltage of 3.7
VDC
Safety rating: IEC 62133,
RoHS, WEEE
Power Charger: 4.2VDC
Lithium Ion smart battery
charger
AC Power Supply: Connects
to charger, wall powered.
Output: 5VDC, 2A.
Input: 100VAC – 240VAC
with adapters for
international capability.
Ratings:
Medical Grade, IEC 60601-1,
IEC 60601-1-11, IEC 60601-
1-2, CE, RoHS, WEEE
Cord: 4 ft (1.2m), 2.5mm DC
connector
Power On Button: Located
on the handle of wand | Same |
| Operational modes | Open Loop Mode: 1000, 2000
and 3000 mW/cm2 *
Closed Loop Mode: 1000,
2000 and 3000 mW/cm2 ** | Repeat Mode: 1000, 1500
and 2000 mW/cm2 *
Direct Restorative Mode:
1000, 1200 and 1500
mW/cm2 **
Turbo Mode: 2000, 2500 and
3000 mW/cm2 ** | Substantially
equivalent |
| Name | LOOP™ LED Curing
Light System (Rev K) | LOOP™ LED Curing
Light System (Rev H) | |
| | *Relative to lens surface
**Relative to the target surface | *Relative to lens surface
**Relative to the target surface | Same |
| | Device indicates mode,
illumination power and time
selection | Device indicates mode,
illumination power and time
selection | Same |
| Light source | LED light, blue and violet
wavelengths
9.7 mm light head diameter | LED light, blue and violet
wavelengths
9.7 mm light head diameter | Same |
| Accessories | LOOP Protective Barrier
Sleeves, LOOP Protective
Light Shield | Barrier Sleeve VALO®,
VALO® Cordless Light
Shield | Same |
| Composition of
Materials | Plastic Housing design ABS,
various colors | Aluminum, anodized various
colors | Substantially
equivalent |
| Sterility | Supplied Non-sterile | Supplied Non-sterile | Same |
| Parameters of
Disinfection | Chemical disinfection with
approved
cleaning/sanitizing agents:
Cavicide products (non-
bleach) Isopropyl alcohol
Lysol disinfectant (alcohol-
based only)
FD 366 (Dürr Dental) | Chemical disinfection with
approved
cleaning/sanitizing agents:
Cavicide products (non-
bleach) Isopropyl alcohol
Ethyl alcohol based cleaners
Lysol disinfectant (alcohol-
based only) | Same |
| Usability/Ergonomics | 3 buttons - 1 cure power, 1
mode select, 1 time select | 2 buttons - 1 cure power, 1
mode select | Substantially
equivalent |
The current device has a setting which allows the dental professional (the user) to disable the "closed loop" functionality so that it operates like any other curing light. The predicate device does not allow "closed loop" to be disabled by the user.
7
VII. Performance Data
The following performance data the substantial equivalence determination:
Biocompatibility Testing
Garrison Dental conducted cytotoxicity, hypersensitivity and reactivity biocompatibility testing because although the device does not come in contact with oral tissue on the chance that contact does occur Garrison confirmed that its product passes biocompatibility requirements.
The biocompatibility evaluation of the LOOP was conducted in accordance with ISO 10993-5:2009 Biological Evaluation of Medical Devices Part-5: Test for In Vitro Cytotoxicity and ISO 10993-10:2010 Biological Evaluation of Medical Devices Part-10: Test for Irritation and Skin Sensitization as recognized by FDA as standards 2-245 and 2-174, respectively. The battery of testing included the following Tests:
- Cytotoxicity - MEM Elution Test
- Maximization Test for Delayed-Type Hypersensitivity in Hartley Guinea Pigs ●
- Intracutaneous (Intradermal) Reactivity Test in New Zealand White Rabbits ●
8
Testing concluded that the test article did not have a cytotoxic effect, did not elicit sensitization and not elicit biologically significant irritation reactions.
Electromagnetic Compatibility (EMC) and Electrical Safety
Electrical safety and EMC testing were conducted on the LoOP and the Lithium-Ion battery. The system complies with the following standards:
- IEC 60601-1 ●
- IEC 60601-2
- IEC 60601-1-6 ●
- IEC 60601-1-11 ●
- IEC 60101-2-57
- IEC 62133 ●
- IEC 62471 ●
- IEC 60601-1 Clause 8 ●
Software Verification and Validation Testing
Software verification and validation testing were conducted. The software for the LOOP was considered as a "moderate" level of concern based on the determination that minor injurv could result prior to mitigation of hazards due to software failure, and because a malfunction of or a latent design flaw could result in an erroneous diagnosis or a delay in delivery of appropriate medical case that would likely lead to minor injury.
Mechanical and Engineering Testing
- Test Performed
- S-LED Design Verification and Plan Report ●
- Vibration, Shock and Environmental Test
- 3-year wand lifecycle durability verification ●
- 3-year durability test report ●
- Clinicians Report - results of in-house evaluation of LOOP prototype
- Long Term Battery Test
- Characterization of Curing Light Tips ●
- . Beam Analysis
- LOOP IFU Spectrum Generation
- ISO 10650-2: 2018 Powered Polymerization Activators ●
- Drop and Ingress Testing ●
- Tip Rotation Life Test
- Top Arm Lift Test and Calibration Reliability Test ●
- Pin Connection Reliability Test ●
- Test IFU Recommended Cleaning Solutions on CLCL and Accessories ●
- . Evaluation of Lens Hardness
9
- Testing Production Barrier Sleeve Effects on CLCL Wand ●
- Functional Thermal Humidity ●
- Reflectance Variation Testing
- Material Compare for RevJ BSleeve ●
- Testing Irradiance Penetration from composites
- Light Shield Effects on Reflectance Measurements
- MARC-LC Certification
- GDS-CLCL-2 Irrad Calibration
- CLCL-5 MARC Correlation ●
- Centroid Device Tolerance Template
- . Optical Inspection
- Re-Testing the CLCL Shield for light blocking effectiveness
- UL746CReview ●
- Testing CLCL reflectance detection of angled surfaces ●
- . Turn on/off Distances of LOOP during In Vivo use
- Testing Auto Start Distances on Human Tissue
- Testing CLCL function over various dental materials
- CLCL Benchmark Irradiance Output at various distances .
- Service Battery
- CLCL Mechanical Attribute Examination ●
- Touch Temp Verification ●
- Elect Leakage and Dielectric
Animal and Clinical Studies
No animal or clinical studies were conducted.
VIII. Conclusion
The LOOP™ LED Curing Light System (rev K) is substantially equivalent to the predicate device, the LOOP™ LED Curing Light System (rev H). Both devices have the same intended use/users, have the same level of power output, are hand-held dental curing lights and both produce blue and UV wavelengths. The differences are in the material that the housing is made from and the user-selectable ability to disable the "closed loop" feature.