FDA.report

Two Striper

Primary DI
B868C8400440
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
STAINBUSTER 2506 6-BUR PACK
Catalog number
C840044
Device description
Abrasive Point
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
EHLPOINT, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B868C8400441PrimaryHIBCC0
B868C8400440Unit of UseHIBCC0

GMDN Terms

TermDefinition
Polymeric dental burA rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
054028295
Device count
6
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

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B868CV1600040Prodia Select368-018FCV1600042026-02-18
B868CV1600050Prodia Select368-018MCV1600052026-02-18
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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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