ABUT. PROTECTOR MINI Ø5.0MM PACK4 PMA 4855 PACK4

GUDID 07899995246325

ABUT. PROTECTOR MINI Ø5.0MM PACK4

Sin Sistema de Implante Nacional S/A

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07899995246325
NIH Device Record Key2315ab4f-d440-4c8d-9704-b93a29f87d23
Commercial Distribution StatusIn Commercial Distribution
Brand NameABUT. PROTECTOR MINI Ø5.0MM PACK4
Version Model NumberPMA 4855 PACK4
Catalog NumberPMA 4855 PACK4
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
GS107899995246325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-13
Device Publish Date2024-06-05

Devices Manufactured by Sin Sistema de Implante Nacional S/A

07899995239457 - VERSALIS S2025-08-26 IMP. VERSALIS S MT16° Ø5.0X11.5MM
07899995239488 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø4.0X20MM
07899995239495 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X13MM
07899995239501 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X11.5MM
07899995239518 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X10MM
07899995239525 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X8.5MM
07899995239532 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø6.0X13MM
07899995239549 - VERSALIS S PLUS2025-08-26 IMP. VERSALIS S PLUS MT16° Ø6.0X11.5MM

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