FDA.report

Hi-Rem+ # 3

Primary DI
08059388443291
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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELRPost, Root Canal

Product Code Classifications

CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08059388441686PrimaryGS10
08059388443291Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08059388441686080593884416868059388441686
08059388443291080593884432918059388443291

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, moisture and direct sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
431704826
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
true
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 DIBrandModelCatalogPublished
08059388443307NeobondNeobondDPNEO12025-08-26
08059388442911Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388442928Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388442935Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388442942Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388442959Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388443215Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388443222Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388443239Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388443246Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388443253Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388442966Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388442973Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388442980Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388442997Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388443000Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388443017Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388443024Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388442881Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388442898Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08059388442911Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388442928Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442935Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442942Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388442959Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388443215Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388443222Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388443239Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388443246Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388443253Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388442966Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388442973Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442980Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442997Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388443000Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388443017Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388443024Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442881Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442898Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442904Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388443147Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388443154Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388443161Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388443178Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388443260Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388443277Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388443284Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388443185Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388443192Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12
08059388443208Hi-Rem Endodontic Post # 3OVERFIBERS SRLELR2025-03-12