Build-It FR

Primary DI
00195062160431
Brand
Build-It FR
Company
Kerr Corporation
Model
N32FA
Device description
Kit - Build-It FR Mini Mix Refill, A2 with 20 intra oral tips and 20 automix wide Opening tips
Published
2026-10-27
Public version status
New
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
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
00195062160431PrimaryGS10
00195062160233Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062160431001950621604311950621604310195062160431
00195062160233001950621602331950621602330195062160233

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.

Contacts#

Phone, Email table
PhoneEmail
800-537-7123kerrcustcare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
Device count
4
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
00195062159787BreezeN97E2026-10-27
00195062159794Breeze RMGIN982026-10-27
00195062160332Build-It FRN32AA2026-10-27
00195062160349Build-It FRN32AB2026-10-27
00195062160356Build-It FRN32AC2026-10-27
00195062160363Build-It FRN32AD2026-10-27
00195062160370Build-It FRN32AE2026-10-27
00195062160387Build-It FRN32FS2026-10-27
00195062160394Build-It FRN32FSA2026-10-27
00195062160400Build-It FRN32FSB2026-10-27
00195062160417Build-It FRN32FSC2026-10-27
00195062160424Build-It FRN32FSD2026-10-27
00195062160448Build-It FRN32FB2026-10-27
00195062160455Build-It FRN32FC2026-10-27
00195062160462Build-It FRN32FD2026-10-27
00195062160479Build-It FRN32FE2026-10-27
00195062160486Build-It FRN32F2026-10-27
00195062160493Build-It FRN322026-10-27
00841396116285NX333642336422016-08-01
10814978021267Build-It FRN32FA2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062160332Build-It FRKerr CorporationEBF2026-10-27
00195062160349Build-It FRKerr CorporationEBF2026-10-27
00195062160356Build-It FRKerr CorporationEBF2026-10-27
00195062160363Build-It FRKerr CorporationEBF2026-10-27
00195062160370Build-It FRKerr CorporationEBF2026-10-27
00195062160387Build-It FRKerr CorporationEBF2026-10-27
00195062160394Build-It FRKerr CorporationEBF2026-10-27
00195062160400Build-It FRKerr CorporationEBF2026-10-27
00195062160417Build-It FRKerr CorporationEBF2026-10-27
00195062160424Build-It FRKerr CorporationEBF2026-10-27
00195062160448Build-It FRKerr CorporationEBF2026-10-27
00195062160455Build-It FRKerr CorporationEBF2026-10-27
00195062160462Build-It FRKerr CorporationEBF2026-10-27
00195062160479Build-It FRKerr CorporationEBF2026-10-27
00195062160486Build-It FRKerr CorporationEBF2026-10-27
00195062160493Build-It FRKerr CorporationEBF2026-10-27
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