FDA.reportPublic FDA data

Anthos

Primary DI
08033837930389
Brand
Anthos
Company
CEFLA SOCIETA' COOPERATIVA
Model
i-MMs
Catalog number
95520662
Device description
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.
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213022000CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LEDCefla S.C.2022-05-09EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033837930389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837930389080338379303898033837930389

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (704)598-0020service@cefladental.com

Regulatory Flags#

DUNS number
429341410
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033837938835no brandNeowise7XPD2026-05-11
08033837935889Anthosi-MMs FLUO955206732026-04-16
08033837935896Anthosi-MMr L FLUO955206722026-04-16
08033837935902Stern Weberi-XS4 FLUO955206752026-04-16
08033837935919Stern Weberi-XR3 L FLUO955206742026-04-16
08033837935926Castelliniimplantor LED FLUO955206772026-04-16
08033837935933Castellinihandy power LED FLUO955206762026-04-16
08033837938316CEFLAAPEX LOCATOR760002012026-03-31
08033837932796Castellinihandy POWER955206662022-06-02
08033837930402Castelliniimplantor LED955206682022-06-01
08033837930723Stern Weberi-XR3955206632022-06-01
08033837930730Stern Weberi-XR3 L955206642022-06-01
08033837930747Stern Weberi-XS4955206652022-06-01
08033837932789Castellinihandy POWER LED955206672022-06-01
08033837935025Anthosi-MMr955206602022-06-01
08033837935032Anthosi-MMr L955206612022-06-01
08033837934981myrayProXIma X6 (2D)70EA00002026-03-13
08033837935001myrayProXIma X6 (3D)70EB00002026-03-13
08033837936091NewTomNewTom VG-One (2D)70ED00002026-03-13
08033837936107NewTomNewTom VG-One (3D)70EF00002026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975069252SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069276Sterling Surgical Motor Main ConsoleBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069283SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069290SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069306SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19