FDA.reportPublic FDA data

Unipack

Primary DI
D784URS559001
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
URS-55900
Catalog number
URS-55900
Device description
Impression Syringes 5ml
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D784URS559005PackageHIBCC10In Commercial Distribution
D784URS559001PrimaryHIBCC0
D784URS559000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D784UBC80461UnipackUBC-8046UBC-80462022-12-06
D784UPST0501UnipackUPST-050UPST-0502022-12-06
D784UPST0751UnipackUPST-075UPST-0752022-12-06
D784UPST1001UnipackUPST-100UPST-1002022-12-06
D784UZM30011UnipackUZM-3001UZM-30012022-12-06
D784UPP10151UnipackUPP-1015UPP-10152016-09-15
D784UPP12181UnipackUPP-1218UPP-12182016-09-16
D784UPP2231UnipackUPP-223UPP-2232016-09-15
D784UPP2251UnipackUPP-225UPP-2252016-09-15
D784UPP27101UnipackUPP-2710UPP-27102016-09-15
D784UPP27101K1UnipackUPP-2710-1KUPP-2710-1K2016-09-16
D784UPP291UnipackUPP-29UPP-292016-09-16
D784UPP32121UnipackUPP-3212UPP-32122016-09-16
D784UPP35101UnipackUPP-3510UPP-35102016-09-16
D784UPP35101K1UnipackUPP-3510-1KUPP-3510-1K2016-09-15
D784UPP35651UnipackUPP-3565UPP-35652016-09-15
D784UPP42121UnipackUPP-4212UPP-42122016-09-15
D784UPP52111UnipackUPP-5211UPP-52112016-09-15
D784UPP52751UnipackUPP-5275UPP-52752016-09-16
D784UPP75131UnipackUPP-7513UPP-75132016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205041005Thermo CloneULTRADENT PRODUCTS, INC.EID2026-08-22
08800017902524EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
07615208353723Mixing TipsIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-08-19
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01