IMP. EPIKUT PLUS MT16° Ø4,5X10,0MM ILM 4510N

GUDID 07899995274069

IMP. EPIKUT PLUS MT16° Ø4,5X10,0MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece
Primary Device ID07899995274069
NIH Device Record Keyf67e6a51-ec0e-4e9b-b87a-0e6a9dd51b7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMP. EPIKUT PLUS MT16° Ø4,5X10,0MM
Version Model NumberILM 4510N
Catalog NumberILM 4510N
Company DUNS904569092
Company NameSin Sistema de Implante Nacional S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899995274069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-29
Device Publish Date2023-06-21

Devices Manufactured by Sin Sistema de Implante Nacional S/A

07899995244796 - IMP. ZYGOMATIC MT16° Ø4.0X60MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X60MM
07899995244802 - IMP. ZYGOMATIC MT16° Ø4.0X57.5MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X57.5MM
07899995244819 - IMP. ZYGOMATIC MT16° Ø4.0X55MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X55MM
07899995244826 - IMP. ZYGOMATIC MT16° Ø4.0X52.5MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X52.5MM
07899995244833 - IMP. ZYGOMATIC MT16° Ø4.0X50MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X50MM
07899995244840 - IMP. ZYGOMATIC MT16° Ø4.0X47.5MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X47.5MM
07899995244857 - IMP. ZYGOMATIC MT16° Ø4.0X45MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X45MM
07899995244864 - IMP. ZYGOMATIC MT16° Ø4.0X42.5MM2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X42.5MM

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