CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

K213022 · Cefla S.C. · EBW · May 9, 2022 · Dental

Device Facts

• Record ID: K213022
• 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
• Applicant: Cefla S.C.
• Product Code: EBW · Dental
• Decision Date: May 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

CEFLA Dental Micromotors are brushless electric motors integrated into CEFLA Dental Units; they drive dental handpieces for restorative, prosthetic, endodontic, and implant procedures. The system consists of a control unit, a cord, and the micromotor; it accepts ISO-type handpiece attachments. The dentist controls rotation speed, torque, and direction (forward/reverse) via the dental unit's software-based interface. The device supports both rotary and reciprocating movement modes. The micromotor provides mechanical power to the handpiece tip to cut or treat dental tissues. Used in clinical dental settings by dental professionals. The device benefits patients by enabling precise, controlled dental interventions across various surgical and restorative applications.

Clinical Evidence

No clinical data. Bench testing only. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366), mechanical performance/cooling/visual inspection (ISO 14457), biocompatibility (ISO 10993-1, ISO 10993-5), and validation of reprocessing/sterility (ISO 11737-2).

Technological Characteristics

Brushless electric micromotor; stainless steel construction (ISO 10993-1, ISO 14457); ISO 3964 handpiece coupling; air cooling; forward/reverse rotation; rotary and reciprocating modes; LED illumination (select models); steam sterilization; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for professional use in dental surgery, including preventive dentistry, restorative applications, endodontic treatment, prosthetic applications, and implantology practices. Intended for use with ISO-type handpiece attachments (straight, contra-angle, gear-reducing, or gear-increasing).

Regulatory Classification

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.

Predicate Devices

• Electric Handpiece Motor EM-12 L (K181858)

Reference Devices

• Surgic Pro+ / Surgic Pro (K173905)
• A-dec/W&H Electric Motor, Model EA-53 (K133776)
• E3 TORQUE CONTROL MOTOR (K103653)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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/a<br>Imola, BO 40026 ITALY<br>Tel. [phone]<br>Fax [phone] |
| Estabilishment<br>Registration<br>Number: | 3006610845 |
| Summary<br>Preparation Date: | May 4th, 2022 |
| Contact Person: | Lorenzo Bortolotti, Regulatory Affairs |
| Telephone<br>Number: | [phone] |
| Email: | [e-mail] |
| Trade/Device<br>name: | CEFLA Dental Micromotors:<br>i-MMr , i-MMr L , i-MMs ;<br>i-XR3 , i-XR3 L , i-XS4 ;<br>handy POWER , handy POWER LED , implantor LED |
| Common or Usual<br>Name: | Dental brushless electric handpiece micromotor |
| Classification<br>Name: | Dental Handpiece and Accessories<br>Classification Name: Dental handpiece and accessories.<br>Device Class: I<br>Product Code: EBW<br>Regulation Number: 21 CFR §872.4200 |
| Description: | The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.<br>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<br>handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic<br>(including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.<br>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 electronic<br>board; |
| | 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, prosthetic<br>applications and implantology practices. |
| Identification of<br>Predicate 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 of<br>technological<br>characteristics<br>with the<br>predicate and<br>reference<br>devices: | | Subject Device | Predicate Device (1) | Reference Device (2) | Reference Device (3) | Reference Device (4) | Justifications for<br>differences | |
| | Trade/<br>Device Name | CEFLA Dental Micromotors | K181858 | K173905 | K133776 | K103653 | | |
| | Applicant | CEFLA S.C | Electric Handpiece<br>Motor EM-12 L | Surgic Pro, Surgic Pro+ | A-dec EA-53 | e3TMTorque<br>Control 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 | // | |
| | Regulation<br>Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | No difference | |
| | Regulatory<br>Class | Class I | Class I | Class I | Class I | Class I | No difference | |
| | Product Code | EBW | EBW | EBW | EBW | EBW | No difference | |
| | Indications for<br>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.<br><br>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.<br><br>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,<br>treatment,<br>applications and implantology<br>practices. | | endodontic<br>prosthetic | endodontic therapy,<br>prosthodontics<br>applications such as<br>crown preparations. | tissues in the<br>mouth. | as: cutting a<br>tooth for cavity<br>preparation,<br>crown<br>preparation,<br>crown finishing,<br>inlay, filing,<br>polishing,<br>prophylaxis and<br>endodontic<br>treatment, with<br>use of a straight,<br>right-angle or<br>contra-angle ISO<br>E-type handpiece<br>attachment of<br>equal speed,<br>gear-reduction<br>speed, or gear-<br>increasing speed. | | |
| Main Dental<br>Applications | Implantology<br>Prosthetic<br>Endodontic<br>Restorative | Prosthetic<br>Restorative | Preventive dentistry,<br>restorative<br>applications,<br>endodontic therapy,<br>prosthodontics<br>applications | Implantology<br>Oral Surgery | Prosthetic<br>Endodontic<br>Restorative | Endodontic | No difference. All<br>dental application are<br>covered by predicate<br>and reference devices. | |
| Device Type | Sub-assembly<br>device<br>intended to be<br>incorporated<br>into a dental unit | | Sub-assembly device<br>intended to be<br>incorporated into a<br>dental unit | Stand-alone device | Sub-assembly<br>device intended<br>to be<br>incorporated<br>into a dental unit | Stand-alone<br>device | No difference. The<br>proposed dental<br>Micromotors are<br>equivalent to their<br>predicate devices | |
| Technological<br>Characteristics<br>(mechanism of<br>action) | Electric brushless micromotor<br>driving dental handpieces<br>fitted with appropriate tools.<br>The micromotor movement,<br>speed and torque are<br>controlled by a dentist<br>through a software-based<br>drive unit. | | Electric brushless<br>micromotor driving<br>dental handpieces<br>fitted with<br>appropriate tools.<br>The micromotor<br>movement, speed<br>and torque are<br>controlled by a<br>dentist through a | Electric brushless<br>micromotor<br>driving dental<br>handpieces fitted<br>with appropriate<br>tools.<br>The micromotor<br>movement, speed<br>and torque are<br>controlled by a | Electric brushless<br>micromotor<br>driving dental<br>handpieces fitted<br>with appropriate<br>tools.<br>The micromotor<br>movement, speed<br>and torque are | Electric brushless<br>micromotor<br>driving dental<br>handpieces fitted<br>with appropriate<br>tools.<br>The micromotor<br>movement, speed<br>and torque are | No difference. The<br>proposed dental<br>Micromotors are<br>equivalent to their<br>predicate devices | |
| | | | software-based drive<br>unit. | dentist through a<br>software-based<br>drive unit. | controlled by a<br>dentist through a<br>software-based<br>drive unit. | controlled by a<br>dentist through a<br>software-based<br>drive unit. | | |
| Micromotor<br>Length | 47.5 mm | 35 mm | 31.55 mm | 103.3 mm (with<br>cord connection) | 36.7 mm | - | No significant<br>difference. The length<br>derived from stator and<br>rotor dimensions. The<br>micro motors with<br>higher torque are<br>longer. Proposed<br>devices are inside the<br>predicate and<br>references device<br>length range. | |
| Micromotor<br>Diameter | 22 mm | 22 mm | 22 mm | 23.5mm | - | - | Not significant<br>differences. The<br>external diameter is<br>basically a<br>consequence of ISO-<br>type connection to<br>handpiece. | |
| Handpiece<br>coupling: | ISO 3964 | - | ISO 3964 | ISO 3964 | ISO 3964 | - | No difference | |
| Range of<br>rotation speed | 100 – 40,000 rpm | 100 – 40,000 rpm | 200 – 40,000 rpm | 100 – 40,000 rpm | 250 - 1000 rpm<br>(at the contra-<br>angle) | -…