(231 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) with Led light, especially suitable for implant & endodontic procedures;
- short version (short) with optional Led light, 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, thought 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.
This document is for Premarket Notification (510(k)) and pertains to dental micromotors, not an AI/ML powered medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not explicitly available in this submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing relevant to the physical device.
However, I can extract information regarding non-clinical performance testing that serves as "acceptance criteria" for this specific medical device, as well as the types of studies conducted to show it meets those criteria:
Non-Clinical Performance Testing (Acceptance Criteria & Reported Performance):
The submission states that various non-clinical tests were conducted and proved the device met the relevant standards. While specific numerical acceptance criteria values are not provided, the "Meets" status implies successful completion against the requirements of the listed standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Study Conducted) |
|---|---|
| Electrical safety (IEC 60601-1) | Test was conducted and performed in accordance with IEC 60601-1. |
| Electromagnetic compatibility (IEC 60601-1-2) | Test was conducted and performed in accordance with IEC 60601-1-2. |
| Usability (IEC 60601-1-2 & IEC 62366) | Usability test was conducted in accordance to IEC 60601-1-2. Application of usability engineering was conducted in accordance to IEC 62366. |
| Mechanical Performance (ISO 14457) | Mechanical Performance and cooling flows and Visual inspection were conducted in accordance to ISO 14457. |
| Biocompatibility (ISO 10993-1 & ISO 10993-5) | Evaluation of biocompatibility is based on ISO 10993-1 and ISO 10993-5. |
| Reprocessing Validation (FDA Guidance) | Validation of the reprocessing according "FDA guidance Reprocessing Medical Devices Health Care Settings: Validation Methods and Labeling." |
| Sterility after reprocessing (ISO 11737-2) | Evaluation of sterility test after reprocessing is based on ISO 11737-2. |
Study Details (based on the provided document):
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical hardware performance tests, not AI/ML model evaluations requiring test sets of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and performance tests against established standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical Testing: Clinical performance testing was not conducted."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the established, quantifiable requirements and limits set forth in the referenced international standards (e.g., IEC 60601-1, ISO 14457).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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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 and 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.
May 9, 2022
CEFLA S.C. Lorenzo Bortolotti Regulatory Affairs Via Selice Provinciale 23/A Imola, BO 40026 ITALY
Re: K213022
Trade/Device Name: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: April 8, 2022 Received: April 11, 2022
Dear Lorenzo Bortolotti:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Michael E. Adjodha, M.ChE. 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) K213022
Device Name
CEFLA Dental Micromotors: i-MMr , i-MMs ; i-XR3 , i-XR3 L , i-XS4 ; handy POWER , handy POWER LED , implantor LED .
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)
| ☒ 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
K213022
| Submitter's Name: | CEFLA S.C. |
|---|---|
| Address: | Via Selice Provinciale 23/aImola, BO 40026 ITALYTel. +39 0542 653111Fax +39 0542 653444 |
| EstabilishmentRegistrationNumber: | 3006610845 |
| SummaryPreparation Date: | May 4th, 2022 |
| Contact Person: | Lorenzo Bortolotti, Regulatory Affairs |
| TelephoneNumber: | +39 0542 653441 |
| Email: | regulatory@cefla.it |
| Trade/Devicename: | CEFLA Dental Micromotors:i-MMr , i-MMr L , i-MMs ;i-XR3 , i-XR3 L , i-XS4 ;handy POWER , handy POWER LED , implantor LED |
| 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) with Led light, especially suitable for implant & endodontic procedures; | |
| 2) short version (short) with optional Led light, 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, thought 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. | |
| 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. | |
| Identification ofPredicate Device: | CEFLA S.C. will refer to the following predicate device (1): |
| Proprietary Name: W&H | |
| Classification Name: Dental Handpiece and Accessories, 21 CFR 872.4200 | |
| Registered Establishment Name: 9681479 | |
| W&H Dentalwerk Buermoos GmbH | |
| Ignaz-Glaser-Strasse 53 | |
| Burmoos, AT 5111 | |
| Owner/Operator: W&H | |
| Establishment Operations: Manufacturer | |
| 510 (k): K181858 | |
| Device Name: Electric Handpiece Motor EM-12 L | |
| Applicant: W&H | |
| CEFLA S.C. will refer to the following reference device (2): | |
| Proprietary Name: NAKANISHI INC. | |
| Classification Name: Dental handpiece and accessories, 21 CFR 872.4200 | |
| Registered Establishment Name: | |
| NAKANISHI INC. | |
| 700 Shimohinata | |
| Kanuma-Shi, Tochigi-Ken Japan 322-8666 | |
| Owner/Operator: NAKANISHI INC. |
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Establishment Operations: Manufacturer 510 (k): K173905 Trade Name: Surgic Pro+ / Surgic Pro Common Name: Controller, Foot, Handpiece And Cord Handpiece, Rotary Bone Cutting Handpiece, Contra- And Right-Angle Attachment, Dental Applicant: NAKANISHI INC.
CEFLA S.C. will refer to the following reference device (3):
Proprietary Name: A-dec Classification Name: Controller, Foot, Handpiece and Cord, 21 CFR 872.4200 Registered Establishment Name: A-dec, Inc. 2601 Crestview Drive Newberg, OR 97132 Owner/Operator: A-dec Establishment Operations: Manufacturer 510 (k): K133776 Trade Name: A-declW&H Electric Motor, Model EA-53 Common Name: Dental Handpiece Electric Motor Applicant: A-dec
CEFLA S.C. will refer to the following reference device (4):
Proprietary Name: DENTSPLY International Classification Name: Dental Handpiece and Accessories, 21 CFR 872.4200 Registered Establishment Name: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Swreet York, PA 17405 Owner/Operator: DENTSPLY International Establishment Operations: Manufacturer 510 (k): K103653
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| Trade Name: E3 TORQUE CONTROL MOTOR | ||||||||
|---|---|---|---|---|---|---|---|---|
| Common Name: dental motor | ||||||||
| Applicant: DENTSPLY International | ||||||||
| Comparison oftechnologicalcharacteristicswith thepredicate andreferencedevices: | Subject Device | Predicate Device (1) | Reference Device (2) | Reference Device (3) | Reference Device (4) | Justifications fordifferences | ||
| Trade/Device Name | CEFLA Dental Micromotors | K181858 | K173905 | K133776 | K103653 | |||
| Applicant | CEFLA S.C | Electric HandpieceMotor EM-12 L | Surgic Pro, Surgic Pro+ | A-dec EA-53 | e3TMTorqueControl Motor | |||
| Image: CEFLA Dental Micromotors | Image: Electric Handpiece Motor EM-12 L | Image: Surgic Pro, Surgic Pro+ | Image: A-dec EA-53 | Image: e3 Torque Control Motor | // | |||
| RegulationNumber | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | No difference | ||
| RegulatoryClass | Class I | Class I | Class I | Class I | Class I | No difference | ||
| Product Code | EBW | EBW | EBW | EBW | EBW | No difference | ||
| Indications forUse | 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 | Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit.The electrical drive, EM-12 L is indicated for use in the field of preventive dentistry, restorative applications including cavity and preparation | The Surgic Pro+ / Surgic Pro is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard | The A-dec W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such | The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement. | Similar Indication for use with the predicate device, which includes 4 out of 5 total dental applications (preventive dentistry, restorative applications, endodontic therapy, prosthodontics applications); implantology application of the subject device is similar to reference device 2. | ||
| applications,treatment,applications and implantologypractices. | endodonticprosthetic | endodontic therapy,prosthodonticsapplications such ascrown preparations. | tissues in themouth. | as: cutting atooth for cavitypreparation,crownpreparation,crown finishing,inlay, filing,polishing,prophylaxis andendodontictreatment, withuse of a straight,right-angle orcontra-angle ISOE-type handpieceattachment ofequal speed,gear-reductionspeed, or gear-increasing speed. | ||||
| Main DentalApplications | ImplantologyProstheticEndodonticRestorative | ProstheticRestorative | Preventive dentistry,restorativeapplications,endodontic therapy,prosthodonticsapplications | ImplantologyOral Surgery | ProstheticEndodonticRestorative | Endodontic | No difference. Alldental application arecovered by predicateand reference devices. | |
| Device Type | Sub-assemblydeviceintended to beincorporatedinto a dental unit | Sub-assembly deviceintended to beincorporated into adental unit | Stand-alone device | Sub-assemblydevice intendedto beincorporatedinto a dental unit | Stand-alonedevice | No difference. Theproposed dentalMicromotors areequivalent to theirpredicate devices | ||
| TechnologicalCharacteristics(mechanism ofaction) | Electric brushless micromotordriving dental handpiecesfitted with appropriate tools.The micromotor movement,speed and torque arecontrolled by a dentistthrough a software-baseddrive unit. | Electric brushlessmicromotor drivingdental handpiecesfitted withappropriate tools.The micromotormovement, speedand torque arecontrolled by adentist through a | Electric brushlessmicromotordriving dentalhandpieces fittedwith appropriatetools.The micromotormovement, speedand torque arecontrolled by a | Electric brushlessmicromotordriving dentalhandpieces fittedwith appropriatetools.The micromotormovement, speedand torque are | Electric brushlessmicromotordriving dentalhandpieces fittedwith appropriatetools.The micromotormovement, speedand torque are | No difference. Theproposed dentalMicromotors areequivalent to theirpredicate devices | ||
| software-based driveunit. | dentist through asoftware-baseddrive unit. | controlled by adentist through asoftware-baseddrive unit. | controlled by adentist through asoftware-baseddrive unit. | |||||
| MicromotorLength | 47.5 mm | 35 mm | 31.55 mm | 103.3 mm (withcord connection) | 36.7 mm | - | No significantdifference. The lengthderived from stator androtor dimensions. Themicro motors withhigher torque arelonger. Proposeddevices are inside thepredicate andreferences devicelength range. | |
| MicromotorDiameter | 22 mm | 22 mm | 22 mm | 23.5mm | - | - | Not significantdifferences. Theexternal diameter isbasically aconsequence of ISO-type connection tohandpiece. | |
| Handpiececoupling: | ISO 3964 | - | ISO 3964 | ISO 3964 | ISO 3964 | - | No difference | |
| Range ofrotation speed | 100 – 40,000 rpm | 100 – 40,000 rpm | 200 – 40,000 rpm | 100 – 40,000 rpm | 250 - 1000 rpm(at the contra-angle) | - | No significantdifference. Theoperative Torque andRotation speed for theproposed "CEFLADental Micromotors",as well as the predicatedevice and thereference devices, areadjustable by thedoctor on dental unitsor control unitsdepending on the | |
| Maximumtorque | 5.3 Ncm | 3.3 Ncm | 3 Ncm | 5 Ncm | 3 Ncm | 20-410 gram-cm | specific applications and the connected handpiece and tip. The proposed device rotation speed and torque ranges includes or are identical to those of the predicate and reference devices declared values. There isn't change in their functionality. | |
| Cooling type | Air | Air | Air | Air | Air | Air | No difference | |
| Direction ofrotation | Forward/Reverse operation. | Forward/Reverse operation. | Forward/Reverse operation. | Forward/Reverse operation. | Forward/Reverse operation. | Forward/Reverse operation. | No difference | |
| Operatingmode: | Rotary and Reciprocating movement. | Rotary | Rotary | Rotary | Rotary | Rotary and Reciprocating movement. | The subjected devices allow to perform both Rotary and Reciprocating movement. Reciprocating movement is a function especially suitable for endodontic application, like for K103653 reference device (4). | |
| Light: | Whit Led | Two variants: with Led & without Led incorporated | With Led | Two variants: with Led & without Led incorporated. | With Led | - | No significant difference. It's just a marketing choice to make a version without Light available for short micromotor. | |
| Water Pressure | 2.5 ± 0,2 bar | - | 0.5 to 3 bar | - | - | - | No significant difference. The water pressure is between the predicate and reference devices declared values and it's in accordance with standard UNI-EN-ISO |
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| 14457 par 5.6.3 Water supply that indicates 250kPa (2,5 bar). | ||||||
|---|---|---|---|---|---|---|
| No difference | ||||||
| Air Pressure | 3 ± 0,2 bar | 3 ± 0,3 bar(range 0.5 to 3 bar) | - | - | - | No difference |
| Contact Materials | Indirect contact with:Stainless Steel. Materials and surface in compliance with ISO 10993-1 and ISO 14457. | Materials and surface in compliance with ISO 10993-1 and ISO 14457. | Materials and surface in compliance with ISO 10993-1 and ISO 14457. | Stainless Steel. Materials and surface in compliance with ISO 10993-1 and ISO 14457. | Materials and surface in compliance with ISO 10993-1. | No significant differences. Materials and Surface are in compliance with the same biocompatibility and safety requirements of applicable standard ISO 10993-1 and ISO 14457. |
| Working times | Intermittent operation. | Intermittent operation. | Intermittent operation. | Intermittent operation. | - | No difference |
| Micromotor Sterilization: | Sterilized by user (steam sterilization) | Sterilized by user (steam sterilization) | Sterilized by user (steam sterilization) | Sterilized by user (steam sterilization) | - | No difference |
| Electrical safety: | Complies with IEC 60601-1. | Complies with IEC 60601-1. | Complies with IEC 60601-1. | Complies with IEC 60601-1. | Complies with IEC 60601-1. | No difference |
| Electromagnetic compatibility: | Complies IEC 60601-1-2. | Complies IEC 60601-1-2. | Complies IEC 60601-1-2. | Complies IEC 60601-1-2. | Complies IEC 60601-1-2. | No difference |
| Non-clinical | Electrical safety Test was conducted and performed in accordance with IEC 60601-1. |
|---|---|
| Performance | Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2. |
| Testing: | Usability test was conducted in accordance to IEC 60601-1-2. |
| Application of usability engineering was conducted in accordance to IEC 62366. | |
| Mechanical Performance and cooling flows and Visual inspection were conducted in accordance to ISO 14457. | |
| Evaluation of biocompatibility is based on: | |
| ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and Testing"; | |
| ISO 10993-5 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity". | |
| Validation of the reprocessing according "FDA guidance Reprocessing Medical Devices Health Care Settings: Validation Methods and Labeling. " | |
| Evaluation of sterility test after reprocessing is based on ISO 11737-2. |
Clinical Testing: Clinical performance testing was not conducted.
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Conclusion: CEFLA S.C. considers the CEFLA Dental Micromotors to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in inciple 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.