FDA.reportPublic FDA data

Flight Dental Systems

Primary DI
D884N6LED19020
Brand
Flight Dental Systems
Company
Flight Dental Systems
Model
N6LED-1902
Device description
Built in Piezo Scaler used for scaling teeth. Removing Carious material. Ultrasonic Scaler
Published
2020-12-22
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
D884N6LED19020PrimaryHIBCC0

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
241275150
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D884BI2530K1Flight Dental SystemsBI-2530K2024-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07630392912617BioSonicDent4You AGELC2026-04-06
07630392912624BioSonicDent4You AGELC2026-04-06
07630392912631BioSonicDent4You AGELC2026-04-06
07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
D00381702011Cavitron®Dentsply ProfessionalELC2026-01-20