FDA.report

FUSION

Primary DI
00816594023680
Brand
FUSION
Company
DANVILLE MATERIALS, LLC
Model
FTXBL
Catalog number
FTXBL
Device description
FUSION,TEMP3,EXTREME,BLEACH
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

Related Records

Contact Domains

Product Codes

CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816594023680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594023680008165940236808165940236800816594023680

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature074 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

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00816594020122ACCOLADE90546905462016-06-22
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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

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