FDA.reportPublic FDA data

US200

Primary DI
07630392909877
Brand
US200
Company
Dent4You AG
Model
60034379
Device description
#10 Universal Optimist, 25kHz
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240801000BioSonic US200 Ultrasonic Scaler (60034537)Dent4you AG2024-07-01ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392909877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392909877076303929098777630392909877

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480152811
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397422042StatClean Ultrasonic CleanerSC-P4862SC-P48622026-03-11
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
17640397422339HIP Cleaning SolutionCS-HIPTCS-HIPT2026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07630243600595BRILLIANT Crios60019985600199852026-02-10
07630243600601BRILLIANT Crios60019986600199862026-02-10
07630243600618BRILLIANT Crios60019987600199872026-02-10
07630243600625BRILLIANT Crios60019988600199882026-02-10
07630243600632BRILLIANT Crios60019989600199892026-02-10
07630243600649BRILLIANT Crios60019990600199902026-02-10
07630243600656BRILLIANT Crios60019991600199912026-02-10
07630243600663BRILLIANT Crios60019992600199922026-02-10
07630243600670BRILLIANT Crios60019993600199932026-02-10
07630243600687BRILLIANT Crios60019994600199942026-02-10
07630243600694BRILLIANT Crios60019995600199952026-02-10
07630243600700BRILLIANT Crios60019996600199962026-02-10
07630243600717BRILLIANT Crios60019997600199972026-02-10
07630243600724BRILLIANT Crios60019998600199982026-02-10
07630243600731BRILLIANT Crios60019999600199992026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
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07613353347819GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
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04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
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045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21