1.5mm-2.5mm ZGO Densah Bur 90mm length

GUDID 00850017652620

ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid implants).

VERSAH, LLC

Orthopaedic bur, reusable
Primary Device ID00850017652620
NIH Device Record Keyf1342320-5e2b-4f1f-9cc7-d3bae903a813
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5mm-2.5mm ZGO Densah Bur 90mm length
Version Model NumberZT1525-90
Company DUNS081472844
Company NameVERSAH, LLC
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

Customer Support Contacts

Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com
Phone844-711-5585
Emailinfo@versah.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017652620 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-07
Device Publish Date2022-06-29

Devices Manufactured by VERSAH, LLC

00810212140001 - VT1828-GS2026-01-15
00810212140018 - VT2838-GS2026-01-15
00810212140025 - VT3848-GS2026-01-15
00810212140032 - VT4858-GS2026-01-15
00810212140049 - VPLTT-G2026-01-15
00810212140056 - VPLTT-GS2026-01-15
00810212140063 - VSINUS2026-01-15
00850017652835 - Densah Bur Holder2026-01-15

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