Vulcan Custom Dental

GUDID 00810033850080

Custom Titanium Abutment, 3.5mm W/ Laser-Lok

VULCAN CUSTOM DENTAL, INC

Dental implant suprastructure, permanent, preformed
Primary Device ID00810033850080
NIH Device Record Key3308bb37-c15e-4ca7-86a7-db2b117a7432
Commercial Distribution StatusIn Commercial Distribution
Brand NameVulcan Custom Dental
Version Model NumberTIABT102LL
Company DUNS080285276
Company NameVULCAN CUSTOM DENTAL, INC
Device Count1
DM Exemptfalse
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 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
GS100810033850080 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810033850080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-09-04

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