FDA.reportPublic FDA data

DX-Ultra Ultrasonic Irrigation

Primary DI
08800017902500
Brand
DX-Ultra Ultrasonic Irrigation
Company
DXM CO., LTD
Model
Disposable Plastic Tip
Catalog number
DXU-9010
Device description
Single-use disposable plastic tips designed specifically for the DX-Ultra Ultrasonic Irrigation system to deliver efficient cavitation and acoustic streaming in root canal procedures.
Published
2026-08-21
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
true

Product Codes#

Code, Name table
CodeName
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017902517PackageGS160In Commercial Distribution
08800017902500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017902517088000179025178800017902517
08800017902500088000179025008800017902500

GMDN Terms#

Term, Definition table
TermDefinition
Root canal ultrasonic irrigation handpiece tipA non-sterile, needle-like endpiece designed to be attached to an ultrasonic dental handpiece and intended to deliver irrigation solution to, and provide debridement of, the root canal by means of ultrasonic mechanical vibration, during an endodontic procedure. This is a single-use device.

Regulatory Flags#

DUNS number
688797315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017902395Fish Bone Bite TraysPosterior Side2026-08-25
08800017902401Fish Bone Bite TraysPosterior Sideless2026-08-25
08800017902418Fish Bone Bite TraysPosterior Half Side2026-08-25
08800017902425Fish Bone Bite TraysQuadrant2026-08-25
08800017902432Fish Bone Bite TraysAnterior2026-08-25
08800017900155DX-Ultra Ultrasonic IrrigationDX-UltraDXU-90002026-08-21
08800017902524EZ VPS Impression Transfer ConnectorsRibbon Holder2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsEZ-5100EZ-51002026-08-21
08800017902470FriendoPen TipFE-10042026-07-13
08800017902487Gutta EasyGun Tip 23 GuageGE-1004-23G2026-07-13
08800017902494Gutta EasyGun Tip 25 GuageGE-1004-25G2026-07-13
08800017901640CybirdULTRA2026-04-21
08800017902289EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017901817EZ Bite blockBB-3000M2025-12-16
08800017900605EZ Bite blockBB-3000M2025-12-16
08800017902203DX-Mixer1802025-09-29
08800017902265DX-Mixer1802025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017900155DX-Ultra Ultrasonic IrrigationDXM CO., LTDJET2026-08-21
08800019151289PVS TipB& L Biotech, inc.JET2025-04-30
08800019151296PVS TipB& L Biotech, inc.JET2025-04-30
08800019151302PVS TipB& L Biotech, inc.JET2025-04-30
08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
08800019151623DB TipB& L Biotech, inc.JET2025-04-30
08800019151630DS TipB& L Biotech, inc.JET2025-04-30
08800019151647DS TipB& L Biotech, inc.JET2025-04-30
08800019151654DS TipB& L Biotech, inc.JET2025-04-30
08800019151661DS TipB& L Biotech, inc.JET2025-04-30
08800019151678TS TipB& L Biotech, inc.JET2025-04-30
08800019151685TS TipB& L Biotech, inc.JET2025-04-30
08800019151692TS TipB& L Biotech, inc.JET2025-04-30
08800019151708TS TipB& L Biotech, inc.JET2025-04-30
08800019151715TS TipB& L Biotech, inc.JET2025-04-30
08800019151722TS TipB& L Biotech, inc.JET2025-04-30
00883205031730OpalpixULTRADENT PRODUCTS, INC.JET2025-03-12
00070942008143GUM® SUNSTAR AMERICAS, INC.JET2025-01-08
08800019151517CI Tip B& L Biotech, inc.JET2024-12-16
08800019151524CI TipB& L Biotech, inc.JET2024-12-16
08800019151319DS TipB& L Biotech, inc.JET2024-12-05
08800019151326DS TipB& L Biotech, inc.JET2024-12-05
08800019151333DS TipB& L Biotech, inc.JET2024-12-05
08800019151340DS TipB& L Biotech, inc.JET2024-12-05
08800019151357DS TipB& L Biotech, inc.JET2024-12-05
08800019151364DS TipB& L Biotech, inc.JET2024-12-05
08800019151371DS TipB& L Biotech, inc.JET2024-12-05
08800019151388DS TipB& L Biotech, inc.JET2024-12-05