(367 days)
The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.
The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:
- long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures:
- short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is especially suitable for prosthetic & restorative procedures.
Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
Furthermore, both versions of micro-motors are intended to be connect with the following two parts: - CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board;
- handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.
The provided text is a 510(k) Summary for a dental device (micromotors). It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance evaluation. It focuses on non-clinical performance testing (electrical safety, EMC, photobiological safety) and states that clinical performance testing was not conducted.
Therefore, I cannot provide the requested information regarding AI/ML performance acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.
The closest relevant sections in the document discuss:
- Non-clinical Performance Testing (Page 18): This section lists various safety and compatibility tests carried out (Electrical safety, Electromagnetic compatibility, Photobiological safety). It states that other non-clinical performance tests were not repeated as the tests performed for the predicate device (K213022) are considered valid for the proposed variants.
- Clinical Testing (Page 18): Explicitly states, "Clinical performance testing was not conducted."
- Conclusion (Page 18): Asserts substantial equivalence based on similarities in intended use, principle of operation, functional design, and established medical use, with differences deemed minor and not negatively affecting substantial equivalence.
In summary, the provided document does not describe the kind of AI/ML performance study, acceptance criteria, or related details that your request asks for. This device is a dental micromotor, not an AI/ML-driven diagnostic or therapeutic device.
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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 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.
April 1, 2024
CEFLA S.C. Simona Daidone Regulatory Affairs Via Selice Provinciale N.23/A Imola, Bologna 40026 ITALY
Re: K230895
Trade/Device Name: CEFLA Dental Micromotors: i-MMr L, i-MMr L FLUO, i-MMs, i-MMs, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L; i-XR3 L FLUO, i-XS4, i-XS4 FLUO; handy POWER, handy POWER LED, handy POWER LED FLUO, implantor LED, implantor LED FLUO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: March 5, 2024
Dear Simona Daidone:
Received: March 5, 2024
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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).
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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
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Indications for Use
510(k) Number (if known) K230895
Device Name
CEFLA Dental Micromotors: i-MMr L, i-MMr L, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L, i-XR3 L, i-XS4, i-XS4 FLUO; handy POWER, handy POWER LED, handy POWER LED FLUO, implantor LED, implantor LED FLUO
Indications for Use (Describe)
The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.
| 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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510(k) SUMMARY, AS REQUIRED BY CFR 807.92 – K230895
| Submitter's Name: | CEFLA S.C. |
|---|---|
| Address: | Via Selice Provinciale 23/a |
| Imola, BO 40026 ITALY | |
| Tel. +39 0542 653111 | |
| Fax +39 0542 653444 | |
| EstablishmentRegistrationNumber: | 3006610845 |
| SummaryPreparation Date: | March 28th, 2024 |
| Contact Person: | Simona Daidone, Regulatory Affairs |
| TelephoneNumber: | +39 0542 653441 |
| Email: | regulatory@cefla.it |
| Trade/Devicename: | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, I-XR3 L FLUO, i-XS4, i-XS4 FLUO; handy POWER, handyPOWER LED, handy POWER LED FLUO, implantor LED, implantor LED FLUO |
| Common or UsualName: | Dental brushless electric handpiece micromotor |
| ClassificationName: | Dental Handpiece and AccessoriesClassification Name: Dental handpiece and accessories.Device Class: IProduct Code: EBWRegulation Number: 21 CFR §872.4200 |
| Description: | The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by ahandpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic(including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.The CEFLA Dental Micromotors family presents two versions:1) long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable forimplant & endodontic procedures: |
| 2) short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the | |
| short version is especially suitable for prosthetic & restorative procedures. | |
| Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the | |
| different lengths and the maximum available torques. | |
| Furthermore, both versions of micro-motors are intended to be connect with the following two parts: | |
| 1) CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronicboard; | |
| 2) handpieces which transmit movement to their tips or other instrument, legally marketed in USA. | |
| The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and | |
| tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece. | |
| Indication for Use: | The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. |
| They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. | |
| They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prostheticapplications and implantology practices. |
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CEFLA S.C.
510(k) Premarket Notification
Identification of CEFLA S.C. will refer to the following predicate devices:
Predicate Device:
Predicate device:
Proprietary Name: CEFLA Classification Name: Dental Handpiece and Accessories, 21 CFR 872.4200 Registered Establishment Name: 3006610845 CEFLA S.C. Via Selice Provinciale 23/a Imola, BO 40026 ITALY Owner/Operator: CEFLA Establishment Operations: Manufacturer 510 (k): K213022 Device Name: CEFLA Dental Micromotors i-MMr L , i-MMs ; i-XR3 L , i-XS4 ; handy POWER , handy POWER LED , implantor LED Applicant: CEFLA
Reference device:
Device name: VALO Grand Corded and accessory Lenses 510(k) number: K210550 Device Classification Name: Ultraviolet activator for polymerization Regulation number: 21 CFR 872.6070 Device Class: Class II Product Code: EBZ Secondary Product Code: EAQ, PEQ
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Applicant: Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
Reference Device:
Device name: VALO X, VALO X accessory Lenses 510(k) number: K220471 Device Classification Name: Ultraviolet activator for polymerization Regulation number: 21 CFR 872.6070 Device Class: Class II Product Code: EBZ Secondary Product Code: EAQ, PEQ Applicant: Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Comparison oftechnologicalcharacteristicswith thepredicate andreferencedevices: | Subject Device | Predicate Device | Reference device | Referencedevice | Justificationsfor differences | |
|---|---|---|---|---|---|---|
| K230895 | K213022 | K210550 | K220471 | |||
| Trade/Device Name | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMS FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, i-XS4 FLUO; handy POWER, handy POWER LED, handy POWER LED FLUO, implantor LED, implantor LED FLUO | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs; i-XR3, i-XR3 L, i-XS4; handy POWER, handy POWER LED, implantor LED | Valo™ Grand Corded and Accessory Lenses | VALO X; VALO X Accessory Lenses | ||
| Applicant | CEFLA S.C | CEFLA S.C | Ultradent Products, Inc. | UltradentProducts,Inc. | ||
| RegulationNumber | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.6070 | 21 CFR 872.6070 | No difference with the predicate device |
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CEFLA Dental Micromotors
| Regulatory Class | Class I | Class I | Class II | Class II | No differencewith thepredicatedevice | |||
|---|---|---|---|---|---|---|---|---|
| Product Code | EBW | EBW | EBZ, EAQ, PEQ | EBZ, EAQ, PEQ | No difference with the predicate device | |||
| Indications for Use | The CEFLA Dental Micromotors arebrushless electric micromotorscontrolled by a control unit insideCEFLA Dental Units. They areintended to be connected with anISO-type handpiece attachment:straight or contra-angle of equal, gearreducing, or gear increasing speed.They are intended for professionaluse in dental surgery such as:preventive dentistry, restorativeapplications, endodontic treatment,prosthetic applications andimplantology practices. | The CEFLA Dental Micromotors arebrushless electric micromotorscontrolled by a control unit insideCEFLA Dental Units. They areintended to be connected with anISO-type handpiece attachment:straight or contra-angle of equal,gear reducing, or gear increasingspeed.They are intended for professionaluse in dental surgery such as:preventive dentistry, restorativeapplications, endodontic treatment,prosthetic applications andimplantology practices. | VALO Grand Corded:Source of illumination for curing ofphoto-activated dental restorativematerials and adhesives.VALO Accessory Lenses:The VALO Accessory Lenses aremultiple-use accessory lensesintended to provide illuminationto aid in visualization during oralprocedures and augment theVALO family of curing lights, whichare a source of illumination forcuring photo-activated dentalrestorative materials andadhesives. VALO AccessoryLenses are not intended forcomplete cure of phot-activatedmaterials and adhesives. | VALO X curinglight is a sourceof illuminationfor curing photo-activated dentalrestorativematerials andadhesives. It isalso intended toprovideillumination toaid invisualizationduring oralprocedures.VALO X curinglight accessory/diffusor lensesare not intendedfor completecure of photo-activatedmaterials andadhesives. | No differencewith thepredicate device.The intended useof the referencedevices aredifferent fromthe intended useof the proposedmicromotorsto because theyare a differentdevice. Thecomparison onlyrefers to thenear-UV LED lightpresent in theproposed device,in the referencedevices. Theintended use ofthe near-UV LEDof theproposed deviceis to illuminatethe oral cavity inthe area to betreated, aswith thewhite LED. | |||
| Therefore,theintended use ofthe near-UV LEDis similar to theintended use ofthe referencedevicesand of the lensesof the referencedevices. | ||||||||
| Main DentalApplications | ImplantologyProstheticEndodonticRestorative | ProstheticRestorative | ImplantologyProstheticEndodonticRestorative | ProstheticRestorative | Restorative | Restorative | No difference | |
| Device Type | Sub-assembly device intended tobe incorporated into a dental unit | Sub-assembly device intended tobe incorporated into a dental unit | Curing light | Curing light | No differencewith thepredicatedevice | |||
| TechnologicalCharacteristicsof(mechanism ofaction) | Electric brushless micromotordriving dental handpieces fittedwith appropriate tools. Themicromotor movement, speed andtorque are controlled by a dentistthrough a software-based driveunit. | Electric brushless micromotordriving dental handpieces fittedwith appropriate tools. Themicromotor movement, speedand torque are controlled by adentist through a software-baseddrive unit. | With its broadband spectrum,VALO Grand Corded is designed topolymerize all light cured productsin the wavelength range of 385-515nm per ISO 10650.VALO has a medical grade,international power supply and issuitable for power outlets from100 to 240 volts. The handpiece isdesigned to rest in a standarddental unit bracket or can becustom mounted using the bracketincluded with the kit. | With itsbroadbandspectrum, VALO™X curing light isdesigned topolymerize alllight-curedproducts in thewavelength rangeof 380–515 nmper ISO10650:2018.The VALO X curinglight can be usedin a corded or | No differencewith thepredicatedevice. | |||
| using the | ||||||||
| Ultradent | ||||||||
| VALO | ||||||||
| rechargeable | ||||||||
| batteries or | ||||||||
| provided VALO X | ||||||||
| cord adapter. The | ||||||||
| curing light is | ||||||||
| designed to | ||||||||
| rest in a standard | ||||||||
| dental unit | ||||||||
| bracket or can be | ||||||||
| custom-mounted | ||||||||
| using the VALO | ||||||||
| surface | ||||||||
| mounting bracket | ||||||||
| included with the | ||||||||
| kit. | ||||||||
| Micromotor | 47.5 mm | 35 mm | 47.5 mm | 35 mm | NA | NA | No difference | |
| Length | ||||||||
| Micromotor | 22 mm | 22 mm | 22 mm | 22 mm | NA | NA | No difference | |
| Diameter | ||||||||
| Handpiececoupling: | ISO 3964 | ISO 3964 | NA | NA | No difference | |||
| Range ofrotation speed | 100 – 40,000 rpm | 100 – 40,000 rpm | NA | NA | No difference | |||
| Maximumtorque | 5.3 Ncm | 3.3 Ncm | 5.3 Ncm | 3.3 Ncm | NA | NA | No difference | |
| Cooling type | Air | Air | NA | NA | No difference | |||
| Direction ofrotation | Forward/Reverse operation. | Forward/Reverse operation. | NA | NA | No difference | |||
| Operating mode: | Rotary andReciprocatingmovement. | Rotary | Rotary andReciprocatingmovement | Rotary | Standard Power Mode: 1000mW/cm²High Power Plus Mode:1600mW/cm²Xtra Power Mode: 3200mW/cm² | Standard PowerMode: 1,100mW/cm²Xtra PowerMode:2,200mW/cm² | No differencewith thepredicatedevice | |
| Light: | Two variants:with & withoutnear UV LEDincorporated,white LED isalwaysincorporated | Three variants:1. without anyLEDincorporated; | White Led | Two variants: LED light, blue and violetwith white wavelengths& withou 12mm head sizet whiteLedincorporated | LED light, blueand violetwavelengths | LED light, blueand violetwavelengths(Curing mode) | No significantdifference. Themicromotorsare available inmore versionsto include a UVled in additionto the white ledalready present |
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| 2. with whiteLEDincorporated;3. with Whiteand near UVLEDsincorporated | LED light, violet orwhitewavelengths(Diagnostic mode)12.5mm head size | in order toprovide visibility ofmaterials andparts of thepatient's mouth tofacilitate dentalpractice inparticular inrestorativemodalities.The features ofthe LED arealso similar tothose of thereferencedevices. | ||||
|---|---|---|---|---|---|---|
| MaximumRadiance | 11800 W/(m²*sr) | NA | - | - | ||
| MaximumIrradiance | 0,034 mW/cm²Note: this value has been measuredaccording to test procedure of IEC62471. | NA | Standard: 900 mW/cm²High: 1,500 mW/cm²Xtra: 2,100mW/cm² | StandardPower Mode:1,100 mW/cm²Xtra PowerMode: 2,200mW/cm²Black light: 425mW/cm² | In comparisonto thereferencedevices,the lightintensity of theLEDs of theproposeddevice arelower than theone of thereferencedevices, |
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| because the proposed device does not have the function of polymerization but it is only intended to illuminate the oral cavity in restorative procedure, in order to distinguish composite materials. | ||||
|---|---|---|---|---|
| Maximum Electrical Power Consumption | 450 mW | 650 mW | - | Black light mode: 522 mWIn comparison to the reference devices,the light intensity of the LEDs of the proposed device are lower than the one of the Reference devices |
| because the proposed device does not have the function of polymerization but it is only |
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| intendedto | ||||||
|---|---|---|---|---|---|---|
| illuminate theoral cavity inrestorativeprocedure, inorder todistinguishcompositematerials. | ||||||
| Exposuretimefor each cycle | 300 seconds (maximum value) | NA | Standard: 10 secondsXtra: 5 secondsThese are the usual exposuretime for curing programs. | Black lightmode: 60seconds | In comparisontotheReferencedevices,themaximumcontinuousexposure timeappears higherbut the lightintensity of theLEDs of theproposeddevicearelower than thereferencedevices. | |
| Peak wavelength | 395 nm ± 5 nm | 395 nm ± 5 nm | VALO Grand Corded: Nominalvalues:395-415nm and 440-480nmAccessory Lenses:All lenses match the curinglights peakwavelengths except:≤420 nm wavelength (BlackLight Lens), | VALO X:Nominalvalues: 380-420nmand 420-515nmVALO XAccessoryLenses: | No differencewiththepredicatedevice.Theproposeddevice does notreachwavelengths in | |
| 500-570nm peak wavelengths(TransLume Green Lens) | All lensesmatch thecuring lightspeakwavelengthsexcept:≤420 nmwavelength(Diffuser LensinBlack LightDiagnosticMode)≥500 nm peakwavelength(TranslumeLens, anymode) | the range of440 - 480 nmlikethereferencedevices,becausethepolymerizationfunction is notpossiblewiththe proposeddevice.Thepeakwavelength ofthe proposeddevice is similarto the peakwavelength ofthe black lightlensindiagnosticmode (≤420nm) of thereferencedevice. | ||||
| Water Pressure | 2.5 ± 0,2 bar | 2.5 ± 0,2 bar | NA | NA | No difference | |
| Air Pressure | 3 ± 0,2 bar | 3 ± 0,2 bar | NA | NA | No difference | |
| ContactMaterials | Indirect contact with: StainlessSteel. Materials and surface incompliance with ISO 10993-1 andISO 14457. | Indirect contact with: StainlessSteel. Materials and surface incompliance with ISO 10993-1 andISO 14457. | NA | NA | No difference | |
| Working times | Intermittent operation. | Intermittent operation. | NA | NA | No difference | |
| MicromotorSterilization: | Sterilized by user (steamsterilization) | Sterilized by user (steamsterilization) | NA | NA | No difference | |
| Electrical safetyandElectromagneticCompatibility: | Complies with IEC 60601-1 and IEC60601-1-2. | Complies with IEC 60601-1 and IEC60601-1-2. | NA | NA | No difference |
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CEFLA S.C.
510(k) Premarket Notification
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| Non-clinicalPerformanceTesting: | Electrical safety Test was conducted and performed in accordance with IEC 60601-1.Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2Photobiological safety test was conducted and performed in accordance with IEC 62471.All other non-clinical performance testing were not repeated because the tests performed for the predicate device K213022 can be considered valid also for the proposed variants of device. |
|---|---|
| ----------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Clinical Testing: | Clinical performance testing was not conducted. |
|---|---|
| Conclusion: | CEFLA S.C. considers the CEFLA Dental Micromotors to be substantially equivalent to the predicate device. This conclusion is based on the similarities in intended use, principle of operation, functional design, and established medical use. Differences between the devices shown in the comparison section above are minor and do not have any negative effect on substantial equivalence. |
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.