FDA.report

US200

Primary DI
07630392909945
Brand
US200
Company
Dent4You AG
Model
60034386
Device description
#10 Slim, 30kHz
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

Related Records

Product Codes

CodeName
ELCScaler, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions

SubmissionSupplement
K240801000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240801000BioSonic US200 Ultrasonic Scaler (60034537)Dent4you AG2024-07-01ELC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630392909945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630392909945076303929099457630392909945

GMDN Terms

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
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

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