FDA.reportPublic FDA data

Water Filter Set (4m)

Primary DI
04560264535213
Brand
Water Filter Set (4m)
Company
NAKANISHI INC.
Model
Water Filter Set (4m)
Published
2026-10-01
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

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
04560264535213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264535213045602645352134560264535213

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn 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 the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Regulatory Flags#

DUNS number
690710546
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560264501911VA750LUX-SCVA750LUX-SC2026-10-01
04560264501935VA750-SCVA750-SC2026-10-01
04560264501942VA-SCVA-SC2026-10-01
04560264501980Water Filter Set (2m)Water Filter Set (2m)2026-10-01
04560264503649VA560LUX-SCVA560LUX-SC2026-10-01
04560264519022VA970-SCVA970-SC2026-10-01
04560264519039VA970LUX-SCVA970LUX-SC2026-10-01
04560264522510VA570-SCVA570-SC2026-10-01
04560264522527VA570LUX-SCVA570LUX-SC2026-10-01
04589551386765FC-15FC-152023-06-05
04560264522336Torque CalibratorTorque Calibrator2020-11-20
04560264566453NLZNLZ CDE2020-07-07
04560264565845TI-MAX X CONTRA/HPX95L2020-06-12
04560264565869TI-MAX X CONTRA/HPX25L2020-06-12
04560264565876TI-MAX X CONTRA/HPX20L2020-06-12
04560264565883TI-MAX X CONTRA/HPX15L2020-06-12
04560264565906TI-MAX X CONTRA/HPX952020-06-12
04560264565913TI-MAX X CONTRA/HPX852020-06-12
04560264578180S-MAX M CONTRA/HPM952021-04-12
04560264578203S-MAX M CONTRA/HPM252021-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560264501911VA750LUX-SCNAKANISHI INC.ELC2026-10-01
04560264501935VA750-SCNAKANISHI INC.ELC2026-10-01
04560264501942VA-SCNAKANISHI INC.ELC2026-10-01
04560264501980Water Filter Set (2m)NAKANISHI INC.ELC2026-10-01
04560264503649VA560LUX-SCNAKANISHI INC.ELC2026-10-01
04560264519022VA970-SCNAKANISHI INC.ELC2026-10-01
04560264519039VA970LUX-SCNAKANISHI INC.ELC2026-10-01
04560264522510VA570-SCNAKANISHI INC.ELC2026-10-01
04560264522527VA570LUX-SCNAKANISHI INC.ELC2026-10-01
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDELC2026-09-24
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
07613353257743AIR-FLOW-PIEZONE.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