UNIT, ANALOGUE, Ø3.5 PLATFORM

GUDID 08435389820291

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08435389820291
NIH Device Record Key166c800e-1a3b-49b2-b342-0facf7dd37b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIT, ANALOGUE, Ø3.5 PLATFORM
Version Model NumberRLMIUPE
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
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 Datetrue
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
GS108435389820291 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-17
Device Publish Date2022-11-09

On-Brand Devices [UNIT, ANALOGUE, Ø3.5 PLATFORM]

08435389820291RLMIUPE
08435389826156RLMIUPE

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