FDA.report

Two Striper

Primary DI
B868C8900030
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
DRILL #3 RED
Catalog number
C890003
Device description
Dental Post Drill
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
false

Related Records

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B868C8900030PrimaryHIBCC0

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
054028295
Device count
1
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

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