FDA.reportPublic FDA data

Henry Schein

Primary DI
H65890047709
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004770
Catalog number
9004770
Device description
Parallel-Sided Post Titan
Published
2020-06-24
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
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
H65890047701PrimaryHIBCC0
H65890047709Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

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