FDA.reportPublic FDA data

ELECTROmatic TMM-S

Primary DI
EKAV101285470
Brand
ELECTROmatic TMM-S
Company
KaVo Dental GmbH
Model
1.012.8547
Catalog number
TMM-S
Device description
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation.The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
Published
2021-03-01
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
K163317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163317000ELECTROmaticKaltenbach & Voigt Gmgh2017-02-21EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101285470PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavokerr.com

Regulatory Flags#

DUNS number
333710619
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV057405000DIAGNOdent 20950.574.050020952016-09-26
EKAV100059540RONDOflex powder 50m (75g)1.000.5954NA2016-09-26
EKAV100059550RONDOflex powder 27m (75g)1.000.5955NA2016-09-26
EKAV100059560RONDOflex powder 50m (1000g)1.000.5956NA2016-09-26
EKAV100059570RONDOflex powder 27m (1000g)1.000.5957NA2016-09-26
EKAV100720000SonicFill Handpiece 349201.007.2000349202016-09-26
EKAV100620270SONICflex implant set A1.006.20271.006.20272025-01-31
EKAV100863840SONICflex prep crown round no. 97 A1.008.63841.008.63842025-01-31
EKAV100863860SONICflex prep crown plain no. 98 A1.008.63861.008.63862025-01-31
EKAV101537000DIAGNOcam Vision Full HD1.015.37001.015.37002024-12-03
EKAV100835000EXPERTsurg LUX1.008.35001.008.35002016-09-26
EKAV100987570Tube Set S6001.009.8757S6002016-09-26
EKAV100880000INTRA LUX S600 LED1.008.80001.008.80002016-09-26
EKAV100910100SURGmatic S11 L1.009.10101.009.10102016-09-26
EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
EKAV101375410SURGmatic S201 XL Pro1.013.75411.013.75412020-01-24
EKAV101112130DIAGNOcam Vision Full HD1.011.12131.011.12132024-02-01
EKAV101315000DIAGNOcam Vision Full HD1.013.15001.013.15002024-02-01
EKAV101402800MASTERmatic LUX M45 L1.014.02801.014.02802024-02-01
EKAV100071050SONICflex cari-ex 0.8 No. 421.000.7105cari ex 0 8 No 422016-09-26

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