FDA.reportPublic FDA data

Piezo Pilot Ultrasonic Scaler

Primary DI
10818207020267
Brand
Piezo Pilot Ultrasonic Scaler
Company
Vista Dental
Model
402711
Device description
Dental ultrasonic scaler uses a wide range of very thin tips for a variety of procedures ranging from routine preventative care to severe periodontal cases. EMS hygiene model.
Published
2018-08-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10818207020267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702026710818207020267

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
036623932
Device count
1
Serial number
true
Manufacturing date on label
true

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