FDA.report

EdgeEndo 04 Paper Points

Primary DI
10819514028014
Brand
EdgeEndo 04 Paper Points
Company
US ENDODONTICS, LLC
Model
SPP4504
Catalog number
SPP4504
Device description
Absorbent Paper Points
Published
2023-04-25
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

Contact Domains

Product Codes

CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819514028017PrimaryGS10
10819514028014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819514028017008195140280178195140280170819514028017
1081951402801410819514028014

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

Contacts

PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags

DUNS number
061317427
Device count
60
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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