FDA.reportPublic FDA data

GBT Machine Wireless Pedal

Primary DI
07613353331184
Brand
GBT Machine Wireless Pedal
Company
E.M.S. Electro Medical Systems S.A.
Model
EK-1055B
Device description
GBT Machine Wireless Pedal
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253254000GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A2026-01-28ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353331184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353331184076133533311847613353331184

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353240011AIR-FLOWEL-308#EL-308#XC2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceEL-542#AEL-542#A/0012026-07-14
07613353194963PIEZON Handpiece S5EN-061/OSEN-061/OS2026-07-14
07613353194994PIEZON BUILT-IN KIT LEDFS-432-OS1-USFS-432-OS1-US2026-07-14
07613353195007PIEZON BUILT IN KIT LEDFS-432-OS-USFS-432-OS-US2026-07-14
07613353195014PIEZON BUILT-IN KITFS-433-OS1-USFS-433-OS1-US2026-07-14
07613353195021PIZON BUILT-IN KITFS-433-OS-USFS-433-OS-US2026-07-14
07613353239992AIR-FLOW Handpiece 120°EL-308#EL-308#NFS2026-07-14
07613353240134PERIO-FLOW HandpieceEL-354#EL-354#NFS2026-07-14
07613353240950PIEZON Handpiece LEDEN-060#EN-060#NFS2026-07-14
07613353257743AIR-FLOW-PIEZONFT-229#FT-229#NFS/5232026-07-14
07613353311803Instrument PI starter kitFS-295#FS-295#C2026-07-14
07613353311896Boost wireless pedalEK-404BEK-404B/D2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceEL-545#EL-545#A2026-07-14
07613353318123GBT Machine Wireless PedalEK-10552026-07-14
07613353318581AIRFLOW Prophylaxis MasterFT-229#FT-229#NFS-01-202026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterFT-300W/AFT-300W/A2026-07-14
07613353343408PIEZON Handpiece LEDEN-060#MXEN-060#MX/NFS2026-07-14
07613353344238PERIO-FLOW HandpieceEL-354#EL-354#MX2026-07-14
07613353028374PIEZONDS-001OS2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353311896Boost wireless pedalE.M.S. Electro Medical Systems S.A.KOJ2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.KOJ2026-07-14
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.KOJ2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.KOJ2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.KOJ2026-06-11
04560264579569CLM HolderNAKANISHI INC.KOJ2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.KOJ2026-06-11
04589551391219Perio Kit2NAKANISHI INC.KOJ2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.KOJ2026-06-11
04589551395323CLM Module SetNAKANISHI INC.KOJ2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.KOJ2026-06-11
04589551395439FC-83NAKANISHI INC.KOJ2026-06-11
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-04-03
00840479201191ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201207ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201214ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201245ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201252ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201269ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201276ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201283ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201290ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201306ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201313ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479202587ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
07613353225940GBT FLOWCONTROL x 4E.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353334925AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353348137AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCKOJ2026-01-14