FDA.reportPublic FDA data

PIEZON

Primary DI
07613353335113
Brand
PIEZON
Company
E.M.S. Electro Medical Systems S.A.
Model
FS-455
Device description
PIEZON Handpiece set
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07613353335113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353335113076133533351137613353335113

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481233849
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
07613353313500GBT Machine StationDW-1002026-02-16
04262477320197SONOGELDV-1552025-09-02
04260153472031Swiss DolorClastDV-0332021-06-02
07613353170264Swiss DolorClastDV-0332020-06-03
07613353352356GBT Machine AIRFLOW Prophylaxis MasterFT-300#NFSFT-300 -01-202026-02-24
07613353180089Instruments A P PSFS-4582026-02-16
07613353180096Instruments PS PSR PSLFS-4592026-02-16
07613353225940GBT FLOWCONTROL x 4FV-112/A2026-02-16
07613353331184GBT Machine Wireless PedalEK-1055B2026-02-16
07613353334925AIR-FLOWFS-465FS-465/MX2026-02-16
07613353335847AIR-FLOWFS-477/US2026-02-16
07613353336837Instruments PSR PSLFS-4612026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2B 3022026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2BV022026-02-16
07613353348137AIR-FLOWFS-474FS-474/MX2026-02-16
07613353341404PiezonEN-060#MX2025-10-21
07613353257224AIR-FLOW-PIEZONFT-229Default2025-10-20
07613353257323AIR-FLOW-PIEZONFT-229-2B-V022025-10-20
07613353257576AIR-FLOW-PIEZONFT-229-2B-3022025-10-20
07613353257866AIR-FLOWFT-230-2B-V022025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630392912617BioSonicDent4You AGELC2026-04-06
07630392912624BioSonicDent4You AGELC2026-04-06
07630392912631BioSonicDent4You AGELC2026-04-06
07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
07613353341404PiezonE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353257224AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257323AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257576AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353258061AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2025-10-20
10810000520630Parkell®PARKELL, INC.ELC2023-10-20
10810000521552Parkell®PARKELL, INC.ELC2023-10-20
J021303230001Proxeo ULTRA PB-510W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303240001Proxeo ULTRA PB-520W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303250001Proxeo ULTRA PB-530W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303260001Proxeo ULTRA Handpiece PB-5 LW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303270001Proxeo ULTRA Handpiece PB-5 L QW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303280001Proxeo ULTRA Handpiece PB-5 L SW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303440001APP-HC-03-XX-00 (Head Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303470001IFB-DC-CO.CO-HS-00 (Interface Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303480001RFB-03-0200-00 (Rectifier-Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHELC2023-07-11
J021301800031"VE-10 82"" W&H white"W & H Dentalwerk Bürmoos GmbHELC2023-07-11