FDA.report

ABSORBENT PAPER POINTS

Primary DI
08806383517331
Brand
ABSORBENT PAPER POINTS
Company
DiaDent Group International
Model
DIA-PROISO-.04 40
Catalog number
258-608
Device description
"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806383517331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806383517331088063835173318806383517331

GMDN Terms

TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and away from Sunlight
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
687789453
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

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06944835173338DIA-X FILE21mm D4571-S1042026-02-20
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06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7 571-S1072026-02-20
06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
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