FDA.reportPublic FDA data

Flight Dental Systems

Primary DI
D884BI2530K1
Brand
Flight Dental Systems
Company
Flight Dental Systems
Model
BI-2530K
Device description
Flight Magnetostrictive Ultrasonic Built in Scaler - Transformer Not Included - IF required Order PN: FLT-D-029
Published
2024-09-23
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
D884BI2530K1PrimaryHIBCC0

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
241275150
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D884QC164K1Flight Dental SystemsQC-164K2024-09-23
D884QC165K1Flight Dental SystemsQC-165K2024-09-23
D884XLITE2NEO1Flight Dental SystemsXlite2NEO2024-09-23
D884F411CA1Flight Dental SystemsF-411CA2024-09-20
D884F416BM1Flight Dental SystemsF-416BMF-416BM2024-09-20
D884F424BM1Flight Dental SystemsF-424BM2024-09-20
D884F424BSU1Flight Dental SystemsF-414BSU2024-09-20
D884F424BW1Flight Dental SystemsF-424BW2024-09-20
D884F424BZ1Flight Dental SystemsF-424BZF-424BZ2024-09-20
D884F434BSUW1Flight Dental SystemsF-414BSUW2024-09-20
D884F541CA1Flight Dental SystemsF-541CA2024-09-20
D884FFBHEAD1Flight Dental SystemsFFB-HEAD2024-09-20
D884FFBYHEAD1Flight Dental SystemsFFB-Y-HEAD2024-09-20
D884FL68HEAD1Flight Dental SystemsF-L68HEAD2024-09-20
D884FL80HEAD1Flight Dental SystemsF-L80HEAD2024-09-20
D884F416Flight Dental SystemsF-416BM2021-12-16
D884AM0004Flight Dental SystemsAM00042022-01-27
D884HB23K000Flight Dental Systemshb23k2022-01-27
D884HB23KL000Flight Dental SystemsHB23KL2022-01-27
D884HE21KL000Flight Dental SystemsHE21KL2022-01-27

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