(124 days)
Not Found
No
The device description and performance studies focus on the laser technology and its safety/EMC compliance. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation or intended use.
Yes
The device description states it has "surgical and therapeutic effects" and lists "Pain Therapy" in its indications for use, which includes temporary relief of pain and muscle relaxation, indicating therapeutic benefits.
No
The device description and intended uses primarily involve surgical, therapeutic, and cosmetic (whitening) procedures. None of the listed functions or indications suggest that the device is used to diagnose a medical condition.
No
The device description clearly states it is a "laser medical device" composed of a console, handpiece, and optical fiber, which are hardware components. It also mentions a laser diode and wireless pedal control. While software is mentioned for verification and validation, the core functionality and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Primo Dental Laser is a medical device that uses laser radiation for surgical and therapeutic effects directly on oral soft tissues and teeth. It performs procedures like incisions, excisions, vaporization, coagulation, and light activation for whitening.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the patient's tissues and teeth.
The intended uses and device description clearly indicate that this is a therapeutic and surgical device used directly on the patient, not a diagnostic device that analyzes samples in vitro.
N/A
Intended Use / Indications for Use
- Dental Soft Tissue Indications
incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscess
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulpotomy as an adjunction to root canal therapy
- Reduction of gingival hypertrophy
- Soft-tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- Tissue retraction for impression
- Reduction of bacterial level (decontamination) and inflammation
- Laser Periodontal Procedures
- Laser soft-tissue curettage
- Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility).
- Whitening
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
- Pain Therapy
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Product codes
NVK, GEX
Device Description
Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties.
Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself.
Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries.
The laser radiation is emitted through a delivery system connected to a handpiece that allows the light to be brought to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft-tissues, periodontal pocket, teeth, minor muscle and joint.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Doctors specialized in Dentistry
Prescription Use
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
The biocompatibility evaluation of the submitted device was conducted in accordance with "ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process". Cytotoxicity, Sensitization, Pyrogenicity, and Irritation biological tests were performed on the applied part optical tips: the results demonstrate biocompatibility.
-Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility testing conducted according to the current revisions of recognized standards demonstrate compliance with the standards:
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for safety O electromagnetic compatibility (EMC)- requirements and tests.
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety O and essential performance.
- IEC 60601-2-22: Medical electrical equipment Part 2-22: Particular requirements for basic O safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 60825-1: Safety of Laser Products Part 1: Equipment classification and requirements. o
-Software Verification and Validation
Software contained in the Epic 980 was developed in accordance with IEC 62304. Software verification and validation testing were performed, and documentation provided in accordance with the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
-Clinical Testing
Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicates.
-Conclusions
Comparison of the Primo Dental Laser subject device with Epic 980 primary predicate (K192430), and secondary predicates devices QuickLase 980, 810 and Dual+ (K100474), SIROLaser Blue (K180044), Epic Pro 940 (K172771) and ELUMI 810 + 980 Soft Tissue Laser (K152032) supports substantial equivalence of the Primo Dental Laser to the identified legally-marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K192430, K100474, K180044, K172771, K152032
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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 27, 2023
Medency S.r.l. Alessandro Zorgati Regulatory Affairs Specialist Via degli Ontani, 48 Vicenza, IT 36100 ITALY
Re: K232222
Trade/Device Name: Primo Dental Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NVK. GEX Dated: November 14, 2023 Received: November 14, 2023
Dear Alessandro Zorgati:
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 (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 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).
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
Submission Number (if known)
K232222
Device Name
Primo Dental Laser
Indications for Use (Describe)
1. Dental Soft Tissue Indications
incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomv
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscess
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulpotomy as an adjunction to root canal therapy
- Reduction of gingival hypertrophy
- Soft-tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- Tissue retraction for impression
- Reduction of bacterial level (decontamination) and inflammation
-
- Laser Periodontal Procedures
- Laser soft-tissue curettage
- Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility).
-
- Whitening
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
- Pain Therapy
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and
4
minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
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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5
1. CONTACT DETAILS
| Applicant Name | Medency Srl |
|---|---|
| Applicant Address | Via degli Ontani, 48 Vicenza IT 36100 Italy |
| Applicant Contact Telephone | +(39) 0444371462 |
| Applicant Contact | Alessandro Zorgati |
| Applicant Contact Email | quality@medency.com |
2. DEVICE NAME
| Device Trade Name | Primo Dental Laser |
|---|---|
| Common Name | Laser surgery instrument for use in general and plastic surgery and |
| dermatology | |
| Classification Name | Powered Laser Surgery Instrument |
| Regulation Number | 878.4810 |
| Product Code | GEX |
3. LEGALLY MARKED PREDICATE DEVICE
| PREDICATE | PREDICATE TRADE NAME | PRODUCT CODE |
|---|---|---|
| PRIMARY | ||
| K192430 | EPIC 980 (Biolase Inc) | GEX |
| SECONDARY | ||
| K100474 | QuickLase 980, 810 and Dual+ (QuickLase Limited) | GEX |
| K180044 | SIROLaser Blue (Dentsplay Sirona) | GEX |
| K172771 | Epic Pro 940 (Biolase Inc) | GEX |
| K152032 | ELUMI 810 + 980 Soft Tissue Laser (Azena Medical, LLC) | GEX |
6
TECHNOLOGY | INNOVATION | PASSION
E10(k) #: K222222
510(k) #: K232222
4. DEVICE DESCRIPTION SUMMARY
Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties.
Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself.
Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries.
The laser radiation is emitted through a delivery system connected to a handpiece that allows the light to be brought to the patient.
5. INTENDED USE/INDICATIONS FOR USE
- Dental Soft Tissue Indications
incision, excision, vaporization and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- -Exposure of unerupted teeth
- Fibroma removal
- -Frenectomy
- -Frenotomy
- Gingival troughing for crown impressions ー
- -Gingivectomy
- ー Gingivoplasty
- -Gingival incision and excision
- Hemostasis and coagulation --
- -Implant recovery
- ー Incision and drainage of abscess
- Leukoplakia
- --Operculectomy
- -Oral papillectomies
- Pulpotomy
- -Pulpotomy as an adjunction to root canal therapy
- --Reduction of gingival hypertrophy
- -Soft-tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa -
- -Vestibuloplasty
- Tissue retraction for impression —
- -Reduction of bacterial level (decontamination) and inflammation
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2. Laser Periodontal Procedures
- Laser soft-tissue curettage -
- Laser remuval of diseased, inflamed and necrosed soft-tissue within periodontal pocket
- -Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility).
3. Whitening
- Light activation for bleaching materials for teeth whitening -
- -Laser-assisted whitening/bleaching of teeth
-
- Pain Therapy
- -Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
6. INDICATION FOR USE COMPARISON
The subject device, Primo Dental Laser family of medical devices, is indicated for dental soft tissue indications, incision, excision, vaporization, ablation and coagulation oforal soft-tissues. The intended use of the main predicate device Epic 980 (K192430) is incision, vaporization, ablation and coagulation of oral soft tissue. Looking at specific treatments there is only one difference in the treatment of 'Decontamination' that is not performed by the predicate. Respect to other predicates, indications for use are almost identical except for minor differences like: predicates QuickLase (K100474) does not perform whitening/bleaching for teeth compared to Primo Dental Laser; then, SirolLase Blue (K180044) and Epic Pro 940 (K172771) do not perform decontamination compared to Primo Dental Laser. These missing treatments are anyway covered by the other predicates.
These are slight differences that do not influence negatively the equivalence between Primo Dental Laser intended use and the one of predicates. Therefore, intended use of Primo Dental Laser does not constitute a new intended use.
7. TECHNOLOGICAL COMPARISON
Talking about wavelengths:
- O the different models of Primo Dental Laser family of devices operate at the following wavelengths: 450nm, 810nm, 940nm and 980nm used individually or in combination with each other (they are a time and never simultaneously).
- Predicate devices K192430, K180044 and K152032 claim equivalence to the models that operate at O 980nm wavelength.
- Predicate devices K100474 and K152032 claim equivalence to the models that operate at 810nm wavelength. O
- Predicate device K180044 claims equivalence to the models that operate at 450nm wavelength. O
- Predicate device K180044 claims equivalence to the model that operate at 635nm wavelength, since the O difference is negligible.
Therefore, the predicate devices are substantially equivalent to the proposed family of medical devices.
8
Talking about the power:
- o Since all predicate devices reach a maximum power equal or higher than 10W (the maximum power of Primo Dental Laser is covered), are substantially equivalent to the proposed family of medical devices.
- Primo Dental Laser family is under the GEX category, a laser surgical instrument. The different models of Primo O Dental Laser family of devices operate at the following wavelengths: 450nm, 635nm, 810nm, 940nm and 980nm used individually or in combination with each other (they are always used one at a time and never simultaneously).
- The radiation emitted by the diode laser is delivered to the optical fiber or through the use o of an accessory.
Primo Dental Laser shares the same technological characteristic as the predicate devices including:
- . the same laser source: solid state diode producing invisible infrared energy;
- . the same wavelengths: 450nm, 635nm, 810nm and 980nm taken individually from predicate devices;
- the same intended use: incision, excision, vaporization, ablation and coagulation of oral soft tissue;
- the same indications for use;
- the same patient-contacting components: glass fiber used in contact and non-contact mode;
- the same use environment;
- . the same tissue type and application regimen;
- . the same principle of operation and emission mode: continuous wave, pulsed or both the same control mechanism;
- . similar design consisting of software-operated portable laser unit, initiated by a footswitch similar delivery system comprising of an optical fiber, handpiece and single use disposable tips / accessories;
- . the same human factors of user interface.
Although some parameters such as maximum power output, power density, pulse rate differ among the devices, these differences do not result is a significantly different clinical performance since the settings and used for the expanded indications as well as the treatment regimen are essentially the same. Therefore, the consolidation of clinical applications creates no new risks or safety concerns.
In conclusion, Primo Dental Laser family has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicated devices.
The proposed laser device is substantially equivalent to the mentioned predicate devices. Performance testing to validate the safety and effectiveness of Primo Dental Laser include electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
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Image /page/9/Picture/0 description: The image shows the logo for MEDENCY, a company focused on technology, innovation, and passion. The logo features a stylized graphic to the left of the company name, both in a blue hue. Below the company's name and logo, the text "TECHNOLOGY | INNOVATION | PASSION" is displayed. The image also includes the text "510(k) #: K232222".
| Specifications | Proposed device | Primary Predicate
device | Secondary Predicate devices | | | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Trade name | Medency
Primo Dental Laser | Biolase Inc.
Epic 980 | QuickLase Limited
QuickLase 980, 810
and Dual+ | Dentsply Sirona
SIROLaser Blue | Biolase Inc.
Epic Pro 940 | Azena Medical, LLC
ELUMI 810 + 980 Soft
Tissue Laser |
| FDA K/number | K232222 | K192430 | K100474 | K180044 | K172771 | K152032 |
| Class | II | II | II | II | II | II |
| Laser medium | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser |
| Laser class | IV | IV | IV | IV | IV | IV |
| Wavelength | 450±10nm
810±10nm
940±10nm
980±10nm
(635+810+980) nm
(450+635+810) nm
(450+635+980) nm | 980±10nm | 980±10nm
810±10nm
(810+980) nm | 970±10nm
660±10nm
445±10nm | 940±10nm | 980±10nm
810±10nm
(810+980) nm |
| Target users | Doctors specialized in
Dentistry | Doctors specialized in
Dentistry | Doctors specialized in
Dentistry | Doctors specialized in
Dentistry | Doctors specialized in
Dentistry | Doctors specialized in
Dentistry |
| Prescription/ | Prescription use | Prescription use | Prescription use | Prescription use | Prescription use | Prescription use |
| | | | | | | |
| over-the-counter use | | | | | | |
| Operation modes | Continuous/Pulsed | Continuous/Pulsed | Continuous/Pulsed | Continuous/Pulsed | Continuous/Pulsed | Continuous/Pulsed |
| Max power | 10W | 10W | 10W | 10W | 25W | 20W |
| Repetition
rate
(Frequency) | Up to 25 kHz | Up to 20 kHz | Up to 20 kHz | Up to 10 kHz | Up to 20 kHz | Up to 20 kHz |
| Aiming beam | 650±20 nm | 625 - 670 nm | 640 - 650 nm | 660 nm | 650 nm | 650 nm |
| Control panel | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen |
| Activation | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch |
| Delivery system | Fiber optic cable,
handpiece,
accessories. | Fiber optic cable,
handpiece,
accessories. | Fiber optic cable,
handpiece,
accessories. | Fiber optic cable,
handpiece,
accessories. | Fiber optic cable,
handpiece,
accessories. | Fiber optic cable,
handpiece,
accessories. |
| Materials in contact
with the patient
tissues. | Optical tip | Optical tip | Optical tip | Optical tip | Optical tip | Optical tip |
| Compliance
to
standards | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1
IEC 60601-2-22 |
| Optical tips | Single-use tips varying
in length and core
Diameter (200 –
400 μm) | Quartz single use tips
varying in length and
core diameter
(200 – 400 μm) | Single use tips varying
in core diameter
(200 - 320 μm) | Fiber Diameter:
200 μm, 320 μm | Quartz single-use tips
varying in length and
core
Diameter (200 –
400μm) | Fiber tip diameter
400 μm core |
| Sterilization method
of optical tips | Steam autoclave | Steam autoclave | Steam autoclave | Optical tips are
sterile provided
(sterilized by ethylene oxide) | Steam autoclave | Gravity steam
sterilization |
| Curved light guide | Biostimulation
handpiece
(8 mm diameter) | Not known | Not known | Curved light guides
(4 mm, diameter) | Not known | Not known |
| Whitening handpiece | 40mmx10mm | 35mmx8mm | Not known | Not known | Not known | Not known |
| Therapy handpiece | Bell therapy handpiece
(10mm diameter) | 30mm diameter | Not known | Not known | Not known | Not known |
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Image /page/10/Picture/0 description: The image shows the logo for MEDENCY, a technology company. The logo includes the company name in blue, followed by the words "TECHNOLOGY | INNOVATION | PASSION" in a smaller font. Below the logo, the text "510(k) #: K232222" is displayed, indicating a regulatory submission number.
11
Image /page/11/Picture/0 description: The image shows the logo for Medency. The logo is blue and includes the word "MEDENCY" in large, bold letters. Below the logo, the words "TECHNOLOGY | INNOVATION | PASSION" are written in smaller letters. The text "510(k) #: K232222" is at the bottom of the image.
Indication for use:
| Specifications and indications for
use of proposed device | Primary Predicate
device | Secondary Predicate devices | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------|-----------------------------------|------------------------------|------------------------------------------------------------|
| Medency
Primo Dental Laser | Biolase Inc.
Epic 980 | QuickLase Limited
QuickLase 980, 810
and Dual+ | Dentsply Sirona
SIROLaser Blue | Biolase Inc.
Epic Pro 940 | Azena Medical, LLC
ELUMI 810 + 980
Soft Tissue Laser |
| K232222 | K192430 | K100474 | K180044 | K172771 | K152032 |
| Dental soft tissue indications: incision,
excision, vaporization, ablation and
coagulation of oral soft-tissues
including marginal and interdental
gingival and epithelial lining of free
gingiva. | ✓ | ✓ | ✓ | ✓ | ✓ |
| Excisional and
incisional biopsies | ✓ | ✓ | ✓ | ✓ | ✓ |
| | | | | | |
| Exposure of unerupted teeth | ✓ | ✓ | ✓ | ✓ | ✓ |
| Fibroma removal | ✓ | ✓ | ✓ | × | ✓ |
| Frenectomy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Gingival troughing for crown impressions | ✓ | ✓ | ✓ | ✓ | ✓ |
| Gingivectomy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Gingivoplasty | ✓ | ✓ | ✓ | ✓ | ✓ |
| Gingival incision and excision | ✓ | ✓ | ✓ | ✓ | ✓ |
| Hemostasis and coagulation | ✓ | ✓ | ✓ | ✓ | ✓ |
| Implant recovery | ✓ | ✓ | ✓ | ✓ | ✓ |
| Incision and drainage of abscess | ✓ | ✓ | ✓ | ✓ | ✓ |
| Leukoplakia | ✓ | ✓ | ✓ | ✓ | ✓ |
| Operculectomy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Oral papillectomies | ✓ | ✓ | ✓ | ✓ | ✓ |
| Pulpotomy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Pulpotomy as an adjunct to root canal therapy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Reduction of gingival hypertrophy | ✓ | ✓ | ✓ | ✓ | ✓ |
| Soft-tissue crown lengthening | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa | ✓ | ✓ | ✓ | ✓ | ✓ |
| Vestibuloplasty | ✓ | ✓ | ✓ | ✓ | ✓ |
| Tissue retraction for impression | ✓ | ✓ | ✓ | ✓ | ✓ |
| Laser soft-tissue curettage | ✓ | ✓ | ✓ | ✓ | ✓ |
| Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket | ✓ | ✓ | ✓ | ✓ | ✓ |
| Sulcular debridement | ✓ | ✓ | ✓ | ✓ | ✓ |
| Light activation for bleaching materials for teeth whitening | ✓ | x | ✓ | ✓ | ✓ |
| Laser-assisted whitening/bleaching of teeth | ✓ | x | ✓ | ✓ | ✓ |
| Reduction of bacterial Level (decontamination) and inflammation | x | ✓ | x | x | ✓ |
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Image /page/12/Picture/0 description: The image shows the logo for Medency. Below the logo, the words "TECHNOLOGY | INNOVATION | PASSION" are written in blue. The text "510(k) #: K232222" is written below the words.
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Image /page/13/Picture/0 description: The image shows the logo for Medency. The logo is in blue and includes the company name, as well as the words "TECHNOLOGY | INNOVATION | PASSION" underneath. The image also includes the text "510(k) #: K232222".
510(k) #: K232222
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8. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS
-Biocompatibility Testing
The biocompatibility evaluation of the submitted device was conducted in accordance with "ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process". Cytotoxicity, Sensitization, Pyrogenicity, and Irritation biological tests were performed on the applied part optical tips: the results demonstrate biocompatibility.
-Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility testing conducted according to the current revisions of recognized standards demonstrate compliance with the standards:
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for safety O electromagnetic compatibility (EMC)- requirements and tests.
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety O and essential performance.
- IEC 60601-2-22: Medical electrical equipment Part 2-22: Particular requirements for basic O safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 60825-1: Safety of Laser Products Part 1: Equipment classification and requirements. o
-Software Verification and Validation
Software contained in the Epic 980 was developed in accordance with IEC 62304. Software verification and validation testing were performed, and documentation provided in accordance with the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
-Clinical Testing
Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicates.
- -Conclusions
Comparison of the Primo Dental Laser subject device with Epic 980 primary predicate (K192430), and secondary predicates devices QuickLase 980, 810 and Dual+ (K100474), SIROLaser Blue (K180044), Epic Pro 940 (K172771) and ELUMI 810 + 980 Soft Tissue Laser (K152032) supports substantial equivalence of the Primo Dental Laser to the identified legally-marketed devices.