FDA.reportPublic FDA data

AIR-FLOW-PIEZON

Primary DI
07613353257743
Brand
AIR-FLOW-PIEZON
Company
E.M.S. Electro Medical Systems S.A.
Model
FT-229#
Catalog number
FT-229#NFS/523
Device description
AIRFLOW Prophylaxis Master
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190124000EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A2019-10-20ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353257743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353257743076133532577437613353257743

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet systemAn assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
07613353170318PIEZONDS-011A/A2026-07-13
07613353170325PIEZONDS-016OS2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.ELC2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.ELC2026-06-11
04560264579569CLM HolderNAKANISHI INC.ELC2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.ELC2026-06-11
04589551391219Perio Kit2NAKANISHI INC.ELC2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.ELC2026-06-11
04589551395323CLM Module SetNAKANISHI INC.ELC2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.ELC2026-06-11
04589551395439FC-83NAKANISHI INC.ELC2026-06-11
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.ELC2026-04-08
07630392912617BioSonicDent4You AGELC2026-04-06