FDA.report

PAPER POINT, Conventional type, XF

Primary DI
08809264298718
Brand
PAPER POINT, Conventional type, XF
Company
Produits dentaires S.A.
Model
25977
Device description
Used in root canal therapy to remove moisture from the root canal or to introduce medicaments Box of 200 - Type XF
Published
2022-06-27
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
08809264298718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809264298718088092642987188809264298718

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
480420090
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07640159161967TOFFLEMIRE MATRIX BANDS X-THIN N.14415162022-06-29
07640159161974TOFFLEMIRE MATRIX BANDS X-THIN N.15415172022-06-29
07640159161981TOFFLEMIRE MATRIX BANDS X-THIN ASSTD415182022-06-29
07640159161998TOFFLEMIRE MATRIX BANDS THIN N°1415212022-06-29
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07640159162018TOFFLEMIRE MATRIX BANDS THIN N°3415232022-06-29

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