Abso Answer

GUDID 08806145475787

DENTOS Inc.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device ID08806145475787
NIH Device Record Keyfcbd29fd-1220-448b-bee2-0dfe8189c3eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbso Answer
Version Model NumberAA-22-11
Company DUNS688355973
Company NameDENTOS Inc.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]
GS108806145475787 [Primary]

FDA Product Code

EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic
EJFBracket, Metal, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Abso Answer]

08806145476173AA-18-22
08806145476166AA-18-21
08806145476159AA-18-17H
08806145476142AA-18-16H
08806145476135AA-18-U45
08806145476128AA-18-13H
08806145476111AA-18-12
08806145476104AA-18-11
08806145475947AA-22-47H
08806145475930AA-22-46H
08806145475923AA-22-445
08806145475916AA-22-37H
08806145475909AA-22-36HH
08806145475893AA-22-36H
08806145475886AA-22-345
08806145475862AA-22-27H
08806145475855AA-22-26H
08806145475848AA-22-22
08806145475831AA-22-21
08806145475824AA-22-17H
08806145475817AA-22-16H
08806145475800AA-22-U45
08806145475794AA-22-12
08806145475787AA-22-11
08806145475770AA-22-43H
08806145475763AA-22-33H
08806145475756AA-22-23H
08806145475749AA-22-13H
08806145475732AA-22-46HH

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