FDA.reportPublic FDA data

Medidenta

Primary DI
00850046903649
Brand
Medidenta
Company
Medidenta
Model
MS25C
Device description
Medi-Scaler 25k 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
00850046903649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046903649008500469036498500469036490850046903649

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
00850046903656MedidentaMS30C2025-01-02
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
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
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.ELC2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.ELC2026-06-11
04560264579569CLM HolderNAKANISHI INC.ELC2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.ELC2026-06-11
04589551391219Perio Kit2NAKANISHI INC.ELC2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.ELC2026-06-11
04589551395323CLM Module SetNAKANISHI INC.ELC2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.ELC2026-06-11
04589551395439FC-83NAKANISHI INC.ELC2026-06-11
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.ELC2026-04-08