FDA.report

Two Striper

Primary DI
B868C8010030
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
CARBOPOST BASIC - 50 ASSTD
Catalog number
C801003
Device description
Dental Root Canal Post
Published
2021-05-25
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
B868C8010031PrimaryHIBCC0
B868C8010030Unit of UseHIBCC0

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
054028295
Device count
50
DM exempt
true
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 DIBrandModelCatalogPublished
B868CV1600010Prodia Select368-016CCV1600012026-02-18
B868CV1600020Prodia Select368-016FCV1600022026-02-18
B868CV1600030Prodia Select368-018CCV1600032026-02-18
B868CV1600040Prodia Select368-018FCV1600042026-02-18
B868CV1600050Prodia Select368-018MCV1600052026-02-18
B868CV1600060Prodia Select368-018XFCV1600062026-02-18
B868CE1600210Prodia Sport135.014XFCE160021-52025-09-26
B868CE1600020Prodia Sport850.016CCE160002-52025-09-24
B868CE1600030Prodia Sport368.023CCE160003-52025-09-24
B868CE1600040Prodia Sport856L.018CCE160004-52025-09-24
B868CE1600050Prodia Sport379.023CCE160005-52025-09-24
B868CE1600060Prodia Sport856.018CCE160006-52025-09-24
B868CE1600090Prodia Sport856.021CCE160009-52025-09-24
B868CE1600110Prodia SportH245CE160011-52025-09-24
B868CE1600120Prodia Sport801.023CCE160012-52025-09-24
B868CE1600150Prodia SportH557CE160015-52025-09-24
B868CEZT000300Two Striper856-018ZXCEZT000302025-09-01
B868CFES00010Two Striper132-008FCFES00012025-09-01
B868CFES00020Two Striper132-008VFCFES00022025-09-01
B868CFES00030Two Striper133-010FCFES00032025-09-01

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
08059388443291Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388443185Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388443192Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12