FDA.reportPublic FDA data

JETSONIC 2000M HANDPIECE

Primary DI
07290016281996
Brand
JETSONIC 2000M HANDPIECE
Company
DELDENT LTD.
Model
533002
Catalog number
533002
Device description
Dental Scaler Handpiece
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014245000JETSONIC 2000Deldent , Ltd.2002-01-29KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016281996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016281996072900162819967290016281996

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
600007124
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016281026MB coupling Midwest5051115051112022-11-22
07290016281033MB coupling Borden5051125051122022-11-22
07290016281040MB Quick coupling Kavo5051135051132022-11-22
07290016281057MB Quick coupling Sirona5051145051142022-11-22
07290016281064MB Quick coupling W&H5051175051172022-11-22
07290016281002Miniblaster Unit5050002016-09-24
07290016281019Miniblaster Nozzle Extension5051302016-09-24
07290016281705JETPOLISHER 2000BORDEN 1.15192002016-09-24
07290016281712JETPOLISHER 2000BORDEN 0.955192102016-09-24
07290016281729JETPOLISHER 2000MIDWEST 1.15193002016-09-24
07290016281736JETPOLISHER 2000MIDWEST 0.955193102016-09-24
07290016281743JETPOLISHER 2000 QD-S 1.15195002016-09-24
07290016281750JETPOLISHER 2000 QD-S 0.955195102016-09-24
07290016281767JETPOLISHER 2000QD - WH 1.15196002016-09-24
07290016281774JETPOLISHER 2000QD - WH 0.955196102016-09-24
07290016281781JETPOLISHER 2000QD - K 1.15199002016-09-24
07290016281798JETPOLISHER 2000QD - K 0.955199102016-09-24
07290016281804JP/JST/JS HANDPIECE BOOSTER5091112016-09-24
07290016281811JP/JST/JS HANDPIECE REGULAR5091202016-09-24
07290016281835JETSTREAM POWDER5000045000042022-03-16

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Primary DI, Brand, Company table
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