FDA.reportPublic FDA data

Build-It FR

Primary DI
00814978021338
Brand
Build-It FR
Company
Kerr Corporation
Model
N32FSA
Device description
Core Material; Syringe with 5 Mixing/Intra-oral Tips; A-3; Refill
Published
2016-08-01
Public version status
Update
Distribution status
Not 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
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814978021338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814978021338008149780213388149780213380814978021338

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
199354556
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
false
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
10814978021267Build-It FRN32FA2016-08-01
10814978021281Build-It FRN32FB2016-08-01
10814978021298Build-It FRN32FC2016-08-01
10814978021304Build-It FRN32FD2016-08-01
10814978021311Build-It FRN32FE2016-08-01
10814978023230Build-It FRN322016-08-01
00814978021185Build-It FRN32AA2016-08-01
00814978021192Build-It FRN32AB2016-08-01
00814978021208Build-It FRN32AC2016-08-01
00814978021215Build-It FRN32AD2016-08-01
00814978021222Build-It FRN32AE2016-08-01
00814978021321Build-It FRN32FS2016-08-01
00814978021345Build-It FRN32FSB2016-08-01
00814978021352Build-It FRN32FSC2016-08-01
00814978021369Build-It FRN32FSD2016-08-01
00814978021437Cement-It Universal C&BN33A2016-08-01
00814978021444Cement-It Universal C&BN33AB2016-08-01
00814978021451Cement-It Universal C&BN33AC2016-08-01
00814978022588BreezeN97E2016-08-01
00814978023240Build-It FRN32F2016-08-01

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