FDA.reportPublic FDA data

DENTOCLIC Tenons Fibre de verre

Primary DI
03760260225083
Brand
DENTOCLIC Tenons Fibre de verre
Company
ITENA CLINICAL
Model
Recharge tenon translucide jaune
Catalog number
FVTJ5-1.3
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760260225083PrimaryGS10
03760260220989Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760260225083037602602250833760260225083
03760260220989037602602209893760260220989

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Regulatory Flags#

DUNS number
278261221
Device count
5
DM exempt
true
Premarket exempt
true
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
03760260222013DENTOCORE BODYAutomixDABODY1-102016-10-15
03760260222020DENTOCORE BODYCartridge A3DCBODY-502016-10-15
03760260222037DENTOCORE Cartridge white shadeDCB-502016-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059388441167Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441174Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441181Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441198Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441204Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441211Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388441228Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388441235Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388441242Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388441259Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388441365Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441372Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441389Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441396Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441402Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441518Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441525Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441556Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441563Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441570Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441617Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388441624Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441631Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388441648Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388441655Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388441662Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388441679Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388441686Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388441778Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441785Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12