FDA.reportPublic FDA data

Hi-Rem+ # 3

Primary DI
08059388441686
Brand
Hi-Rem+ # 3
Company
OVERFIBERS SRL
Model
Hi-Rem+ # 3
Catalog number
RHP603
Published
2025-03-12
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
08059388441686PrimaryGS10
08059388443291Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059388441686080593884416868059388441686
08059388443291080593884432918059388443291

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, moisture and direct sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
431704826
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059388443307NeobondNeobondDPNEO12025-08-26
08059388441167Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388441174Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388441181Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388441198Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388441204Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388441211Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388441228Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388441235Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388441242Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388441259Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388441365Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388441372Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388441389Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388441396Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388441402Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388441518Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388441525Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388441556Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388441563Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

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
08059388441778Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441785Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12
08059388441792Hi-Rem Endodontic Post # 3OVERFIBERS SRLELR2025-03-12