XP-4D 5031702U0

GUDID 08404535012149

XP-4D BIO GP CONES MEDIUM 60P

Peter Brasseler Holdings, LLC

Synthetic gutta-percha
Primary Device ID08404535012149
NIH Device Record Keye3312983-d4ad-496b-80d6-aed307d09777
Commercial Distribution StatusIn Commercial Distribution
Brand NameXP-4D
Version Model Number5031702U0
Catalog Number5031702U0
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535012149 [Primary]

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-03-12
Device Publish Date2025-01-31

On-Brand Devices [XP-4D]

08404535012354XP-4D ABSORBENT PP ASST 100P
08404535012323XP-4D ABSORBENT PP LARGE 100P
08404535012293XP-4D ABSORBENT PP MEDIUM 100P
08404535012262XP-4D ABSORBENT PP STANDARD100P
08404535012231XP-4D ABSORBENT PP STARTER 100P
08404535012200XP-4D BIO GP CONES ASST 60P XP
08404535012170XP-4D BIO GP CONES LARGE 60P X
08404535012149XP-4D BIO GP CONES MEDIUM 60P
08404535012118XP-4D BIO GP CONES STANDARD 60
08404535012088XP-4D BIO GP CONES STARTER 60P
08404535013078XP-4D SEQUENCE 31MM 6P
08404535013047XP-4D Sequence 25MM 6P
08404535013016XP-4D Sequence 21MM 6P
08404535012989XP-4D ASST 03 31MM 4P
08404535012958XP-4D ASST 03 25MM 4P
08404535012927XP-4D ASST 03 21MM 4P
08404535012897XP-4D LARGE 50 03 31MM 3P
08404535012866XP-4D MEDIUM 40 03 31MM 3P
08404535012835XP-4D STANDARD 30 03, 31MM 3P
08404535012804XP-4D STARTER 20 03 31MM 3P
08404535012774XP-4D LARGE 50 03 25MM 3P
08404535012743XP-4D MEDIUM 40 03 25MM 3P
08404535012712XP-4D STANDARD 30 03, 25MM 3P
08404535012682XP-4D STARTER 20 03 25MM 3P
08404535012651XP-4D LARGE 50 03 21MM 3P
08404535012620XP-4D MEDIUM 40 03 21MM 3P
08404535012590XP-4D STANDARD 30 03, 21MM 3P
08404535012569XP-4D STARTER 20 03 21MM 3P

Trademark Results [XP-4D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XP-4D
XP-4D
79399927 not registered Live/Pending
FKG Dentaire Sàrl
2024-06-20

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.