FDA.reportPublic FDA data

JP/JST/JS HANDPIECE

Primary DI
07290016281811
Brand
JP/JST/JS HANDPIECE
Company
DELDENT LTD.
Model
REGULAR
Catalog number
509120
Device description
Dental Airpolishing Handpiece
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
07290016281811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016281811072900162818117290016281811

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet system control unitA device that is a component of a chairside dental abrasive air jet system and that is used to control and regulate the supply of air and water that is fed through a dedicated intraoral handpiece (not included) together with an abrasive powder giving a concise jet that impacts the surface of the teeth being treated. The dentist will typically regulate the air/water supply through controls on the front panel whilst a foot-switch controls the abrasion process. Pressurized air from a standard air compressor and temperate water are connected to this device.

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
false
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
07290016281750JETPOLISHER 2000QD-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 HANDPIECEBOOSTER5091112016-09-24
07290016281019Miniblaster Nozzle Extension5051302016-09-24
07290016281835JETSTREAM POWDER5000045000042022-03-16

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Primary DI, Brand, Company table
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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
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