Orthodontic Bracket

GUDID 08806145471574

DENTOS Inc.

Orthodontic bracket, metal
Primary Device ID08806145471574
NIH Device Record Key3c4ee275-18fe-4574-abd1-f1530942ad78
Commercial Distribution Discontinuation2021-09-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOrthodontic Bracket
Version Model NumberAC-22-D26
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
GS108806145471574 [Primary]

FDA Product Code

EJFBracket, Metal, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-30
Device Publish Date2018-06-08

On-Brand Devices [Orthodontic Bracket]

08806145474476AC-18-W77
08806145474469AC-18-W66
08806145474452AC-18-W46
08806145474445AC-18-W36
08806145474438AC-18-W26
08806145474421AC-18-W16
08806145474414AC-18-L12
08806145474407AC-18-D77
08806145474391AC-18-D66
08806145474384AC-18-D46
08806145474377AC-18-D36
08806145474360AC-18-D26
08806145474353AC-18-D16
08806145474346AC-18-55
08806145474339AC-18-445
08806145474322AC-18-43
08806145474315AC-18-345
08806145474308AC-18-33
08806145474292AC-18-247
08806145474285AC-18-245
08806145474278AC-18-23
08806145474261AC-18-22
08806145474254AC-18-21
08806145474247AC-18-145
08806145474230AC-18-137
08806145474223AC-18-13
08806145474216AC-18-12
08806145474209AC-18-11
08806145474193AC-22-W77
08806145474186AC-22-W66
08806145474179AC-22-W46
08806145474162AC-22-W36
08806145474155AC-22-W26
08806145474148AC-22-W16
08806145472717AC-22-55
08806145471826AC-22-D66
08806145471659AC-22-D46
08806145471642AC-22-445
08806145471635AC-22-43
08806145471628AC-22-D36
08806145471611AC-22-345
08806145471604AC-22-33
08806145471598AC-22-L12
08806145471581AC-22-247
08806145471574AC-22-D26
08806145471567AC-22-245
08806145471550AC-22-23
08806145471543AC-22-22
08806145471536AC-22-21
08806145471529AC-22-137

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