FDA.reportPublic FDA data

DENTOCORE BODY

Primary DI
03760260222013
Brand
DENTOCORE BODY
Company
ITENA CLINICAL
Model
Automix
Catalog number
DABODY1-10
Published
2016-10-15
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121769000DENTOCORE / DENTOCORE BODYItena Clinical2013-03-05EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760260222013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760260222013037602602220133760260222013

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
278261221
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760260221009TOTALCEMA2TTLCEM-A22016-10-15
03760260221016TOTALCEMTranslucentTTLCEM-TR2016-10-15
03760260221023DENTOTEMPautomix syringe IntroKitDTCA1-52016-10-15
03760260221030PROVITEMPAutomix syringePTEMP1-102016-10-15
03760260221047PREVENT SEALPVSEAL-1.2PVSEAL-1.22016-10-15
03760260221054DENTOCEMDCA-2.5DCA-2.52016-10-15
03760260221061TOTAL C-RAMTRANSLUCENTTTCRAM-TR2017-06-11
03760260221078TOTAL C-RAMOPAQUETTCRAM-OD2017-06-11
03760260221085OBTURYSHandmixOBHM1-52017-11-02
03760260221092OBTURYSAutomixOBAX1-52017-10-31
03760260221160TOTALCEMA2ECHTLCEM2017-10-31
03760260221177PREVENT SEALECHPVSEALECHPVSEAL2017-10-31
03760260221184DENTOTEMPautomixECHDTP2017-10-31
03760260221207TOTAL C-RAMTRANSLUCENTECHTCRAM2017-10-31
03760260221214OBTURYSAutomixECHOBYS2017-10-31
03760260221221PROVITEMPAutomix syringeECHPVTEMP2017-10-31
03760260222006DENTOCORE AutomixDCSAK12016-10-15
03760260222020DENTOCORE BODYCartridge A3DCBODY-502016-10-15
03760260222037DENTOCORE Cartridge white shadeDCB-502016-10-15
03760260222044DENTOCORE Cartridge A3 shadeDCA3-502016-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292046Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292060Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292077Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292084Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292091Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292107Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292114Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292121Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208006605SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-23
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22