Easter Self-Ligating Bracket,.022 Roth, #3 w/hs

GUDID 06973329322082

Astar Orthodontics Inc.

Orthodontic bracket, metal
Primary Device ID06973329322082
NIH Device Record Key42ee6444-bccd-4eda-9a6e-143e8f2c7d50
Commercial Distribution StatusIn Commercial Distribution
Brand NameEaster Self-Ligating Bracket,.022 Roth, #3 w/hs
Version Model Number1831-55-3H
Company DUNS547794613
Company NameAstar Orthodontics 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973329322082 [Primary]

FDA Product Code

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 Date2024-01-08
Device Publish Date2023-12-31

On-Brand Devices [Easter Self-Ligating Bracket,.022 Roth, #3 w/hs ]

069733293220821831-55-3H
869416735159681831-011

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.