FDA.reportPublic FDA data

Vivid KleenSert

Primary DI
D724R9101120
Brand
Vivid KleenSert
Company
PEARSON DENTAL SUPPLIES, INC.
Model
R910112
Device description
P-10 30k
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D724R9101120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, endodonticAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082874108
Device count
1
Kit
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D724H6503001Vivid TruEtch 40% H65-03002018-05-09
D724H6503021Vivid TruEtch 40% H65-03022018-05-09
D724H6503041Vivid TruEtch 40% UnisyringeH65-03042018-05-09
D724H6503061Vivid TruEtch 40% Jumbo syringeH65-03062018-05-09
D724H6503081Vivid TruEtch 40% Jumbo syringeH65-03082018-05-09
D724H6503101Vivid TruEtch 10% Kit H65-03102018-05-09
D724Z0603121Vivid Etch 40%z0603122016-06-29
D724Z0603141Vivid Etch 40%Z0603142016-06-29
D724Z0603160Vivid Etch 40%Z0603162016-06-29
D724Z0603180Vivid Etch 40% refillZ0603182016-06-29
D724Z0603200VividEtch 40% Jumbo 60gm RefillZ0603202016-07-07
D724Z0603241Vivid Etch 10%z0603242016-06-29
D724D4407260Vivid TempFill LCD4407462016-06-28
D724S2702701Vivid Root MTA S2702702016-06-30
D724J0800061N'Sure Indicator TapeJ0800062016-07-26
D724J0800081N'Sure Indicator TapeJ0800082016-07-26
D724J0800101N'Sure Indicator TapeJ0800102016-07-26
D724D0104501Vivid Surebond VIID0104502016-06-21
D724D0104521Vivid Surebond VII RefillD0104522016-06-21
D724S2702601Vivid Ceramic PrimeS2702602016-06-30

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
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
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