Absoanchor Microimplant

GUDID 08806145400284

DENTOS Inc.

Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw
Primary Device ID08806145400284
NIH Device Record Key8b0cddf0-7ba6-4b2a-89ea-b236b360b06a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbsoanchor Microimplant
Version Model NumberSH1312-08
Company DUNS688355973
Company NameDENTOS Inc.
Device Count2
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806145400284 [Primary]
GS108806145405289 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


[08806145400284]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-01-03
Device Publish Date2016-08-01

On-Brand Devices [Absoanchor Microimplant]

08806145413703γ-TH2018-12
08806145413697γ-TH2018-11
08806145413680γ-TH2018-08
08806145413673γ-TH2018-07
08806145413666γ-TH2018-06
08806145413659γ-TH2018-05
08806145413642γ-TH1817-12
08806145413635γ-TH1817-11
08806145413628γ-TH1817-10
08806145413611γ-TH1817-09
08806145413604γ-TH1817-08
08806145413598γ-TH1817-07
08806145413581γ-TH1817-06
08806145413574γ-TH1817-05
08806145413567γ-TH2018-10
08806145413550γ-TH2018-09
08806145413543γ-LH1615-12
08806145413536γ-LH1615-10
08806145413529γ-LH1615-08
08806145413512γ-LH1615-07
08806145413505γ-LH1615-06
08806145413499γ-LH1615-05
08806145413482γ-LH1413-12
08806145413475γ-LH1413-10
08806145413468γ-LH1413-08
08806145413451γ-LH1413-07
08806145413444γ-LH1413-06
08806145413437γ-LH1413-05
08806145413420γ-NH1413-07
08806145413413γ-NH1413-06
08806145413406γ-NH1413-05
08806145413369γ-PH1615-12
08806145413352γ-PH1615-10
08806145413345γ-PH1615-08
08806145413338γ-PH1615-07
08806145413321γ-PH1615-06
08806145413314γ-PH1615-05
08806145413307γ-PH1514-12
08806145413291γ-PH1514-10
08806145413284γ-PH1514-08
08806145413277γ-PH1514-07
08806145413260γ-PH1514-06
08806145413253γ-PH1514-05
08806145413246γ-PH1413-12
08806145413239γ-PH1413-10
08806145413222γ-PH1413-08
08806145413215γ-PH1413-07
08806145413208γ-PH1413-06
08806145413192γ-PH1413-05
08806145413185γ-PH1312-12

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