Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a brushless electric micromotor for dental procedures, focusing on mechanical and electrical specifications. There is no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as being used for various dental procedures such as preventive applications, endodontic treatment, prosthetic applications, and implantology practices, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is described as a brushless electric micromotor control unit used for dental procedures. Its intended uses primarily involve mechanical actions like rotation of drills for restorative, prosthetic, endodontic, and implant surgery. It is a tool for performing treatments, not for identifying or diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a physical dental micromotor with a control unit, not a software-only device. The description details hardware components like brushless electric micromotors, LED lights, and connections to a dental unit and handpieces.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for professional use in dental surgery for procedures like preventive applications, endodontic treatment, prosthetic applications, and implantology practices. These are all clinical procedures performed directly on the patient.
Device Description: The description details a mechanical device (micromotor) used to rotate a drill or other tool for dental procedures. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Reagents, calibrators, or controls.

The device is a tool used during dental procedures on a patient, not a device used to diagnose conditions by testing samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 applications, endodontic treatment, prosthetic applications and implantology practices.

Product codes

EBW

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use in dental surgery

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance Testing: Electrical safety Test was conducted and performed in accordance with IEC 60601-1. Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2 Photobiological 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K213022

Reference Device(s)

K210550, K220471

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

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.

High Power Plus Mode:
1600mW/cm²

Xtra Power Mode: 3200mW/cm² | Standard Power
Mode: 1,100
mW/cm²

without any
LED
incorporated; | White Led | Two variants: LED light, blue and violet
with white wavelengths
& withou 12mm head size
t white
Led
incorporated | LED light, blue
and violet
wavelengths | LED light, blue
and violet
wavelengths
(Curing mode) | No significant
difference. The
micromotors
are available in
more versions
to include a UV
led in addition
to the white led
already present | |

9

10

Page 7 of 15

11

12

13

| | | 2. with white
LED
incorporated;
3. with White
and near UV
LEDs
incorporated | | | LED light, violet or
white
wavelengths
(Diagnostic mode)
12.5mm head size | in order to
provide visibility of
materials and
parts of the
patient's mouth to
facilitate dental
practice in
particular in
restorative
modalities.

The features of
the LED are
also similar to
those of the
reference
devices. |
|-----------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum
Radiance | 11800 W/(m²*sr) | | NA | - | - | |
| Maximum
Irradiance | 0,034 mW/cm²
Note: this value has been measured
according to test procedure of IEC
62471. | NA | Standard: 900 mW/cm²
High: 1,500 mW/cm²
Xtra: 2,100mW/cm² | Standard
Power Mode:
1,100 mW/cm²
Xtra Power
Mode: 2,200
mW/cm²
Black light: 425
mW/cm² | In comparison
to the
reference
devices,
the light
intensity of the
LEDs of the
proposed
device are
lower than the
one of the
reference
devices, | |

14

15

				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 mW
In 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 |

Page 12 of 15

16

| | | | | | intended
to | |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | | | illuminate the
oral cavity in
restorative
procedure, in
order to
distinguish
composite
materials. | |
| Exposure
time
for each cycle | 300 seconds (maximum value) | NA | Standard: 10 seconds
Xtra: 5 seconds
These are the usual exposure
time for curing programs. | Black light
mode: 60
seconds | In comparison
to
the
Reference
devices,
the
maximum
continuous
exposure time
appears higher
but the light
intensity of the
LEDs of the
proposed
device
are
lower than the
reference
devices. | |
| Peak wavelength | 395 nm ± 5 nm | 395 nm ± 5 nm | VALO Grand Corded: Nominal
values:
395-415nm and 440-480nm
Accessory Lenses:
All lenses match the curing
lights peak
wavelengths except:
≤420 nm wavelength (Black
Light Lens), | VALO X:
Nominal
values: 380-
420nm
and 420-
515nm
VALO X
Accessory
Lenses: | No difference
with
the
predicate
device.
The
proposed
device does not
reach
wavelengths in | |
| | | | 500-570nm peak wavelengths
(TransLume Green Lens) | All lenses
match the
curing lights
peak
wavelengths
except:
≤420 nm
wavelength
(Diffuser Lens
in
Black Light
Diagnostic
Mode)
≥500 nm peak
wavelength
(Translume
Lens, any
mode) | the range of
440 - 480 nm
like
the
reference
devices,
because
the
polymerization
function is not
possible
with
the proposed
device.
The
peak
wavelength of
the proposed
device is similar
to the peak
wavelength of
the black light
lens
in
diagnostic
mode (≤420
nm) of the
reference
device. | |
| | | | | | | |
| 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 | |
| Contact
Materials | Indirect contact with: Stainless
Steel. Materials and surface in
compliance with ISO 10993-1 and
ISO 14457. | Indirect contact with: Stainless
Steel. Materials and surface in
compliance with ISO 10993-1 and
ISO 14457. | NA | NA | No difference | |
| Working times | Intermittent operation. | Intermittent operation. | NA | NA | No difference | |
| Micromotor
Sterilization: | Sterilized by user (steam
sterilization) | Sterilized by user (steam
sterilization) | NA | NA | No difference | |
| Electrical safety
and
Electromagnetic
Compatibility: | Complies with IEC 60601-1 and IEC
60601-1-2. | Complies with IEC 60601-1 and IEC
60601-1-2. | NA | NA | No difference | |

Page 13 of 15

17

CEFLA S.C.

510(k) Premarket Notification

18

| Non-clinical
Performance
Testing: | Electrical safety Test was conducted and performed in accordance with IEC 60601-1.
Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2
Photobiological 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.