FDA.reportPublic FDA data

EXACTA Cement Xtra

Primary DI
00815619020468
Brand
EXACTA Cement Xtra
Company
EXACTA DENTAL PRODUCTS INC
Model
1-7450
Catalog number
1-7450
Device description
EXACTA Cement Xtra 11g Syringe
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102917000FIXTEMP C&BExacta Dental Direct, Inc.2011-06-17EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815619020468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815619020468008156190204688156190204680815619020468

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

Regulatory Flags#

DUNS number
016325552
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815619021809EXACTA Temp XtraShade A1NA1-FS2016-08-30
00815619021830EXACTA Temp XtraShade A3.5NA3.5-FS2016-08-30
00815619020420FRESH Bold Impression MaterialCartridge of Bite Registration1-70672016-09-16
00815619020451EXACTA Cement Xtra1-74331-74332016-09-23
00815619020536FRESH Bold Impression MaterialMonophase Cartridge1-74862016-09-23
00815619020550FRESH Bold Impression MaterialMedium Body Cartridge1-74922016-09-23
00815619020567FRESH Bold Impression MaterialHeavy Body Cartridge1-74932016-09-23
00815619020574FRESH Bold Impression MaterialClear Bite Cartridge1-74942016-09-23
00815619020581FRESH Bold Impression MaterialLiquid Putty Cartridge1-74952016-09-23
00815619020598FRESH Bold Impression MaterialMonophase Fast Set Cartridge1-74962016-09-23
00815619020604FRESH Bold Impression MaterialLight Body Fast Set Cartridge1-74972016-09-23
00815619020628FRESH Bold Impression MaterialBlu Max Bite Registration Cartridge1-7701-FS2016-09-23
00815619020871FRESH Bold Impression MaterialHeavy Body Mega Pack7483M2016-09-23
00815619020888FRESH Bold Impression MaterialPutty74852016-09-23
00815619021120FRESH Bold Impression MaterialBite Registration70672016-09-16
00815619021137FRESH Bold Impression MaterialBite Registration Bulk7067BK2016-09-16
00815619021168EXACTA Cement Xtra743374332016-09-16
00815619021175EXACTA Cement Xtra745074502016-09-16
00815619021267FRESH Bold Impression MaterialMonophase74862016-09-16
00815619021274FRESH Bold Impression MaterialMonophase Bulk7486BK2016-09-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20