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
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
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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
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