FDA.reportPublic FDA data

EZ PickUp 15g Syringe,15 Tips,5ml Varnish

Primary DI
00841549100451
Brand
EZ PickUp 15g Syringe,15 Tips,5ml Varnish
Company
STERNGOLD DENTAL LLC
Model
220237
Device description
A tissue-colored, self-curing composite attachment processing material. Intended for fixation of secondary parts and connection elements in dentures/prostheses.
Published
2017-02-20
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549100451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549100451008415491004518415491004510841549100451

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
401-871-3489maria.rao@sterngold.com

Regulatory Flags#

DUNS number
124763728
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
true
Expiration date on label
true
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
00841549115783Hader Bar® 8100012022-12-14
00841549115790Hader Bar® 8100032022-12-14
00841549115806Hader Bar® 8100052022-12-14
00841549115813Hader Bar® 8100072022-12-14
00841549115820Hader Bar® 8100102022-12-14
00841549115899Hader Bar® 8100582022-12-14
00841549115851Master8100302022-12-14
00841549115868Lab8100352022-12-14
00841549115875Hader8100402022-12-14
00841549115882Hader8100552022-12-14
00841549119187Stern Snap One Piece Abutment 1mm Cuff (BK)9047302024-06-24
00841549119194Stern Snap One Piece Abutment 2mm Cuff (BK)9047312024-06-24
00841549119200Stern Snap One Piece Abutment 3mm Cuff (BK)9047322024-06-24
00841549119217Stern Snap One Piece Abutment 4mm Cuff (BK)9047332024-06-24
00841549119224Stern Snap One Piece Abutment 5mm Cuff (BK)9047342024-06-24
00841549119231Stern Snap Abutment Base 2.4mm (BK)9047352024-06-24
00841549119248Stern Snap Abutment Base 3.0mm (BK)9044542024-06-24
00841549119255Stern Snap Abutment Base 4.0mm (BK)9044552024-06-24
00841549119262Stern Snap Abutment Base 5.0mm (BK)9044562024-06-24
00841549119279ORA Implant Abutment 1.0mm Cuff (BK)9044872024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201747329FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747398FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747404FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747497FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747589FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747596FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747688FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747695FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747701FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747886FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747978FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201746728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747114FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747190FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
08800055726953C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02