FDA.reportPublic FDA data

ENDODONTIC POSTS

Primary DI
D821033PSF650R0
Brand
ENDODONTIC POSTS
Company
RHEIN 83 SRL
Model
PIVOT FLEX mm.7,0 RIV.TiN
Catalog number
033PSF650R
Device description
DISPOSABLE Titanium device with tilting head to be cemented into the root canal, with retentive pink caps, metal housing for the caps, directional rings and protective disc.
Published
2021-01-05
Public version status
Update
Distribution status
Not 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
D821033PSF650R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
439240722
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059224151496OT EQUATOR-OT BRIDGEANALOGO ACC. da laboratorio EQ144AEY2026-08-27
08059224151502OT EQUATOR-OT BRIDGETRANSFER da IMPRONTA NORMO pz.044CAINY2026-08-27
08059224151519OT EQUATORCAPPETTE EQUATOR NERE da labor140CENY2026-08-27
08059224151526OT EQUATORSMART BOX OT EQUATOR330SBEY2026-08-27
08059224151588OT EQUATORESTRATTORE CAPP. c/st. INSERIT485ICEY2026-08-27
08059224160993OT EQUATORCAPPETTE EQUATOR VIOLA tenuta140CEVY2026-08-27
08059224161006OT EQUATORCAPPETTE EQUATOR ROSA soft pz.140CERY2026-08-27
08059224161013OT EQUATORCONTENITORI ACC. EQUATOR pz.2140CAEY2026-08-27
08059224161037OT EQUATORCAPPETTE EQUATOR B/TRASP. stan140CETY2026-08-27
08059224161044OT EQUATORCAPPETTE EQUATOR GIALLO extra-140CEGY2026-08-27
08059224161051OT EQUATORDISCHETTI PROTETTIVI pz.10100PDY2026-08-27
08059224197746OT EQUATORCAPPETTA ROSA MICRO 6 PZ040CRMSN-SM2026-08-27
08059224197753OT EQUATORCAPPETTA DR8 ARANCIO MICRO, 6 PZ049PCMDR8-SM2026-08-27
08059224197760OT EQUATORCAPPETTA DIAM 2.25, DR8 ROSA040CRNSNDR8-SM2026-08-27
08059224197777OT EQUATORCONTENITORE ACCIAIO MICRO, 2 PZ041CAM-SM2026-08-27
08059224197784OT EQUATORCONTENITORE ACCIAIO NORMO, 2 PZ041CAN-SM2026-08-27
08059224197791OT EQUATORCAPPETTA DIAM 2.50, ROSA040CRNSN-SM2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX - ASTRA ø 4 h.1KEF49AS4NC12026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX SEVEN ø3,3 h.1KEF44SMD3312026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4KEF49NAC3542026-08-27

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