FDA.reportPublic FDA data

Medidenta

Primary DI
00850046903656
Brand
Medidenta
Company
Medidenta
Model
MS30C
Device description
Medi-Scaler 30k Professional Ultrasonic Scaler
Published
2025-01-02
Public version status
New
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
00850046903656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046903656008500469036568500469036560850046903656

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

Regulatory Flags#

DUNS number
012401576
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046903649MedidentaMS25C2025-01-02
00850046903410MedidentaPM-EM-EZPM-EM-EZ2023-11-14
00850046903427MedidentaNLR-EZNLR-EZ2023-11-14
00850046903366MedidentaQD-Switch-AQD-Switch-A2023-06-30
00850046903373MedidentaQD-Switch-BQD-Switch-B2023-06-30
00850046903380MedidentaQD-SwitchQD-Switch2023-06-30
00850046903236MedidentaAF90-PDAF90-PD2023-01-25
00850046903243MedidentaAFT90-PDAFT90-PD2023-01-25
00850046903250MedidentaAF45-PDAF45-PD2023-01-25
00850046903267MedidentaAFT45-PDAFT45-PD2023-01-25
00850046903274MedidentaPL-UDFSPL-UDFS2023-01-25
00850046903007MedidentaME-30LME-30L2022-12-30
00850046903014MedidentaME-40LME-40L2022-12-30
00850046903021MedidentaME-EME-E2022-12-30
00850046903038MedidentaME-ENME-EN2022-12-30
00850046903045MedidentaME-EMME-EM2022-12-30
00850046903052MedidentaME-E30LME-E30L2022-12-30
00850046903069MedidentaME-E40LME-E40L2022-12-30
00850046903076MedidentaME-40FGPME-40FGP2022-12-30
00850046903083MedidentaME-DM25ME-DM252022-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551388899VA170LUXS10NAKANISHI INC.ELC2026-10-06
04560264508422VA-SG-SCNAKANISHI INC.ELC2026-10-05
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
04560264535213Water Filter Set (4m)NAKANISHI 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