FDA.reportPublic FDA data

JETPOLISHER 2000

Primary DI
07290016281750
Brand
JETPOLISHER 2000
Company
DELDENT LTD.
Model
QD-S 0.95
Catalog number
519510
Device description
Dental Airpolishing Unit
Published
2016-09-24
Public version status
Update
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
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014249000JETPOLISHERDeldent , Ltd.2002-02-19KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016281750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016281750072900162817507290016281750

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet systemAn assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600007124
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
07290016281842JETSTREAM115 V5063002023-06-07
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
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 2000QD-S 1.15195002016-09-24
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 HANDPIECEBOOSTER5091112016-09-24
07290016281811JP/JST/JS HANDPIECEREGULAR5091202016-09-24
07290016281019Miniblaster Nozzle Extension5051302016-09-24
07290016281835JETSTREAM POWDER5000045000042022-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.KOJ2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.KOJ2026-06-11
04560264579569CLM HolderNAKANISHI INC.KOJ2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.KOJ2026-06-11
04589551391219Perio Kit2NAKANISHI INC.KOJ2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.KOJ2026-06-11
04589551395323CLM Module SetNAKANISHI INC.KOJ2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.KOJ2026-06-11
04589551395439FC-83NAKANISHI INC.KOJ2026-06-11
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-04-03
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