FDA.reportPublic FDA data

Flight Dental Systems

Primary DI
D884FMS25300
Brand
Flight Dental Systems
Company
Flight Dental Systems
Model
FMS-2530
Catalog number
Flight Magnetostrictive TableTop Ultrasonic Scaler
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
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
D884FMS25300PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
9057990517INFO@FLIGHTDENTALSYSTEMS.COM

Regulatory Flags#

DUNS number
241275150
Device count
1
Serial number
true
Manufacturing date on label
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
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
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