FDA.reportPublic FDA data

PERIO-FLOW Handpiece

Primary DI
07613353344238
Brand
PERIO-FLOW Handpiece
Company
E.M.S. Electro Medical Systems S.A.
Model
EL-354#
Catalog number
EL-354#MX
Device description
PERIOFLOW MAX Handpiece
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
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

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
07613353344238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353344238076133533442387613353344238

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true
Serial number
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353187101SWISS DolorClastDDW-0552022-10-28
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
07613353028374PIEZONDS-001OS2026-07-13

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Primary DI, Brand, Company table
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D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
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