MALE DAL-BO TINY® ABUTMENT L:4 mm.

GUDID 08435389805243

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08435389805243
NIH Device Record Key4bd74394-9273-42de-8230-1b55939d4cc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALE DAL-BO TINY® ABUTMENT L:4 mm.
Version Model NumberMTDT4
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us

Device Dimensions

Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter
Height4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389805243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


[08435389805243]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-17

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389823803 - SHORT DRILL; Ø 6MM2023-08-30
08435389825296 - WIDE PLATFORM POSITIONER (2 UNITS)2023-07-07
08435389825319 - TINY® PLATFORM POSITIONER (2 UNITS)2023-07-07
08435389825333 - UNIVERSAL PLATFORM POSITIONER (2 UNITS)2023-07-07
08435389825357 - UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)2023-07-07
08435389825364 - SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)2023-07-07
08435389825302 - SHORT POSITIONER FOR WIDE PLATFORM (2 UNITS)2023-07-07
08435389825326 - SHORT POSITIONER FOR TINY® PLATFORM (2 UNITS)2023-07-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.