Who can help prepare an FDA 510(k) submission like 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,?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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,

Q: Who is the manufacturer of 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,?

Cefla S.C. filed the 510(k) submission for 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, (K230895).

Q: What is the FDA product code for 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,?

EBW. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

Q: What is the regulatory pathway for 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,?

510(k) clearance (submission type: Traditional).

K230895 · Cefla S.C. · EBW · Apr 1, 2024 · Dental

Device Facts

Record ID	K230895
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,
Applicant	Cefla S.C.
Product Code	EBW · Dental
Decision Date	Apr 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Indications for 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

Brushless electric micromotors integrated into CEFLA dental units; drive dental handpieces for restorative, prosthetic, endodontic, and implant procedures. Input: electrical power from dental unit control board; output: variable speed/torque rotation of handpiece-mounted tools. Features include white LED or white/near-UV LED illumination for oral cavity visualization. Operated by dentists in clinical settings. Near-UV light used for distinguishing composite materials; not for polymerization. Device connects to dental unit via cord; compatible with ISO 3964 handpieces. Benefits include precise control of tool rotation and improved visibility during dental procedures.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and photobiological safety (IEC 62471).

Technological Characteristics

Brushless electric micromotor; stainless steel construction (ISO 10993-1, ISO 14457). ISO 3964 coupling. Speed range 100–40,000 rpm; max torque 5.3 Ncm. Air cooling. Integrated white/near-UV LED illumination. Software-based drive unit control. Steam sterilization. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for professional dental surgery including preventive, endodontic, prosthetic, and implantology procedures. Intended for use with ISO-type handpiece attachments (straight or contra-angle) in dental units.

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

CEFLA Dental Micromotors i-MMr L, i-MMs; i-XR3 L, i-XS4; handy POWER, handy POWER LED, implantor LED (K213022)

Reference Devices

VALO Grand Corded and accessory Lenses (K210550)
VALO X, VALO X accessory Lenses (K220471)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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 (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). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) 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) | | |----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 | | Establishment Registration Number: | 3006610845 | | Summary Preparation Date: | March 28th, 2024 | | Contact Person: | Simona Daidone, Regulatory Affairs | | Telephone Number: | +39 0542 653441 | | Email: | regulatory@cefla.it | | 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 | | Common or Usual Name: | Dental brushless electric handpiece micromotor | | Classification Name: | Dental Handpiece and Accessories Classification Name: Dental handpiece and accessories. Device Class: I Product Code: EBW Regulation 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 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: 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 for implant & 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 electronic board; | | | 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, prosthetic applications and implantology practices. | {5}------------------------------------------------ {6}------------------------------------------------ #### 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 {7}------------------------------------------------ #### 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 of technological characteristics with the predicate and reference devices: | | Subject Device | Predicate Device | Reference device | Reference device | Justifications for 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. | Ultradent Products, Inc. | | | | Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.6070 | 21 CFR 872.6070 | No difference with the predicate device | {8}------------------------------------------------ ## CEFLA Dental Micromotors | Regulatory Class | Class I | Class I | Class II | Class II | No difference with the predicate device | | | | |--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Product Code | | EBW | EBW | EBZ, EAQ, PEQ | EBZ, EAQ, PEQ | No difference with the predicate device | | | | Indications 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 applications and implantology practices. | 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 applications and implantology practices. | VALO Grand Corded: Source of illumination for curing of photo-activated dental restorative materials and adhesives. VALO Accessory Lenses: The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of phot-activated materials and adhesives. | VALO X curing light is a source of illumination for curing photo- activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo- activated materials and adhesives. | No difference with the predicate device. The intended use of the reference devices are different from the intended use of the proposed micromotors to because they are a different device. The comparison only refers to the near-UV LED light present in the proposed device, in the reference devices. The intended use of the near-UV LED of the proposed device is to illuminate the oral cavity in the area to be treated, as with the white LED. | | | | | | | | | | | Therefore, the intended use of the near-UV LED is similar to the intended use of the reference devices and of the lenses of the reference devices. | | | Main Dental Applications | Implantology Prosthetic Endodontic Restorative | Prosthetic Restorative | Implantology Prosthetic Endodontic Restorative | Prosthetic Restorative | Restorative | Restorative | No difference | | | Device Type | Sub-assembly device intended to be incorporated into a dental unit | | Sub-assembly device intended to be incorporated into a dental unit | | Curing light | Curing light | No difference with the predicate device | | | Technological Characteristics of (mechanism of action) | Electric brushless micromotor driving dental handpieces fitted with appropriate tools. The micromotor movement, speed and torque are controlled by a dentist through a software-based drive unit. | | Electric brushless micromotor driving dental handpieces fitted with appropriate tools. The micromotor movement, speed and torque are controlled by a dentist through a software-based drive unit. | | With its broadband spectrum, VALO Grand Corded is designed to polymerize all light cured products in the wavelength range of 385- 515nm per ISO 10650. VALO has a medical grade, international power supply and is suitable for power outlets from 100 to 240 volts. The handpiece is designed to rest in a standard dental unit bracket or can be custom mounted using the bracket included with the kit. | With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380–515 nm per ISO 10650:2018. The VALO X curing light can be used in a corded or | No difference with the predicate device. | | | | | | | | | | | | | | | | | | | using the | | | | | | | | | | Ultradent | | | | | | | | | | VALO | | | | | | | | | | rechargeable | | | | | | | | | | batteries or | | | | | | |…

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,

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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,

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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