FDA.reportPublic FDA data

FUSION

Primary DI
00816594023666
Brand
FUSION
Company
DANVILLE MATERIALS, LLC
Model
FTXA3
Catalog number
FTXA3
Device description
FUSION,TEMP,EXTREME,A3
Published
2016-09-20
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
false

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
00816594023666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594023666008165940236668165940236660816594023666

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature074 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)743-7744xxx@xxx.xxx

Regulatory Flags#

DUNS number
601302743
Device count
1
DM exempt
true
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
00816594020122ACCOLADE90546905462016-06-22
00816594020238ACCOLADE90551905512016-06-22
00816594021600MICROPRIME87001870012016-06-22
00816594021617MICROPRIME94263942632016-06-22
00816594020092ACCOLADE OP93598935982016-06-22
00816594020108ACCOLADE90552905522016-06-22
00816594020115ACCOLADE90553905532016-06-22
00816594020139ACCOLADE90547905472016-06-22
00816594020146ACCOLADE90548905482016-06-22
00816594020153ACCOLADE90549905492016-06-22
00816594020160ACCOLADE90840908402016-06-22
00816594020177ACCOLADE90554905542016-06-22
00816594020184ACCOLADE90550905502016-06-22
00816594020191ACCOLADE90555905552016-06-22
00816594020207ACCOLADE90556905562016-06-22
00816594020214ACCOLADE90557905572016-06-22
00816594020221ACCOLADE90558905582016-06-22
00816594020245ACCOLADE OP93597935972016-06-22
00816594020252ACCOLADE PV91231912312016-06-22
00816594020269ACCOLADE PV90559905592016-06-22

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