IMP. ZYGOMATIC MT16° Ø4.0X45MM ILMZ 4045E

GUDID 07899995244857

IMP. ZYGOMATIC MT16° Ø4.0X45MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece
Primary Device ID07899995244857
NIH Device Record Keyf9270bfe-a966-45de-959a-e02891e2b9f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMP. ZYGOMATIC MT16° Ø4.0X45MM
Version Model NumberILMZ 4045E
Catalog NumberILMZ 4045E
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
GS107899995244857 [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 Date2024-08-09
Device Publish Date2024-08-01

Devices Manufactured by Sin Sistema de Implante Nacional S/A

07899995254634 - CAD-CAM ABUTMENT2025-08-12 ABUT. INTERFACE MT16° 4MM
07899995256447 - CAD-CAM ABUTMENT2025-08-12 ABUT. INTERFACE MT16° 5MM
07899995256577 - CAD-CAM ABUTMENT2025-08-12 ABUT. INTERFACE MT16° 3MM
07899995256676 - CAD-CAM ABUTMENT2025-08-12 ABUT. INTERFACE MT16° 1.5MM
07899995256768 - CAD-CAM ABUTMENT2025-08-12 ABUT. INTERFACE MT16° 0.5MM
07899995243744 - Epikut surgical kit2025-03-03 Epikut surgical kit
07899995243775 - Epikut surgical kit2025-03-03 Epikut surgical kit
07899995262462 - ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX2024-12-23 ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.