FDA.reportPublic FDA data

Flight Dental Systems

Primary DI
D178FMS25300
Brand
Flight Dental Systems
Company
Flight Dental Systems USA Inc.
Model
FMS-2530
Device description
The Flight Magnetostrictive Ultrasonic Scaler is designed for use in prophylaxis treatments periodontal, endodontics and other areas of operative dentistry. When used in prophylaxis treatment, the unit operates with a fine warm water spray, requiring little of the physical exertion necessary with hand instruments. It easily and effectively removes stubborn calculus and stains both supra gingival and sub gingival, leaving crown and root surfaces clean and smooth.
Published
2025-08-29
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040396000ULTRASONIC SCALER ELEGANCE MS-10 (25K)Rolence Enteprise, Inc.2004-04-22ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D178FMS25300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpieceA hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119439759
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D178A12H0Flight Dental SystemsA12HA12H2025-08-29
D178A12HP1000Flight Dental SystemsA12H-100A12 Operatory Package2025-08-29
D178A6E0Flight Dental SystemsA6E2025-08-29
D178A6EP1000Flight Dental SystemsA6EP-1002025-08-29
D178A6EP10120Flight Dental SystemsA6EP-1022025-08-29
D178BI22530K1Flight Dental SystemsBI-2530K2025-08-29
D178F160Flight Dental SystemsF-1602025-08-29
D178N6LED19020Flight Dental SystemsN6LED-19022025-08-29
D178QC164K1Flight Dental SystemsQC-164K2025-08-29
D178QC165K1Flight Dental SystemsQC-165K2025-08-29
D178QC170Flight Dental SystemsQC-170KQC-170K2025-08-29
D178XR3800Flight Dental SystemsXR-3800X-Vision2025-08-29
D178CLAVE16Flight Dental SystemsClave16+Clave16+2025-07-18
D178CLAVE23Flight Dental SystemsClave23+Clave23+2025-07-18
D178CLAVE28Flight Dental SystemsClave28+Clave28+2025-07-18
D178CLAVE45Flight Dental SystemsClave45+Clave45+2025-07-18
D178CLAVE8Flight Dental SystemsClave8+Clave8+2025-07-18

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
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
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13