NeoLucent Plus

GUDID 00190707002114

NeoLucent Plus .022 UL 4/5 HK -7T 0A 2DO

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic
Primary Device ID00190707002114
NIH Device Record Key18be46a5-43d3-461d-8f27-959415b4d86f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLucent Plus
Version Model Number704-360HK-5
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190707002114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, ceramic, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [NeoLucent Plus]

00190707005207NeoLucent Plus/Maestro .018 Kit U/L 5x5 MC HKS
00190707003319NeoLucent® Plus™ .018 Kit U/L 3x3 Roth HK
00190707002299NeoLucent Plus .022 Kit U/L 5X Roth HKS
00190707002282NeoLucent Plus .022 Kit U/L 5X5 Roth HKS
00190707002275NeoLucent Plus .022 Kit U/L 5X5 MC HKS
00190707002268NeoLucent Plus .022 Kit U/L 5x Rondeau Rx Roth HKS
00190707002251NeoLucent Plus/Maestro .022 Kit U/L 5x5 Roth HKS
00190707002244NeoLucent Plus/Maestro .022 Ki U/L 5x5 MC HKS
00190707002237NeoLucent Plus .022 LL5 HK -22T 0A 4DO
00190707002220NeoLucent Plus .022 LR5 HK -22T 0A 4DO
00190707002213NeoLucent Plus .022 LL5 HK -17T 2A 0O
00190707002206NeoLucent Plus .022 LR5 HK -17T 2A 0O
00190707002190NeoLucent Plus .022 LL4 HK -17T 0A 4DO
00190707002183NeoLucent Plus .022 LR4 HK -17T 0A 4DO
00190707002176NeoLucent Plus .022 LL4 HK -12T 2A 0O
00190707002169NeoLucent Plus .022 LR4 HK -12T 2A 0O
00190707002152NeoLucent Plus .022 LL3 HK -6T 3A 0O
00190707002145NeoLucent Plus .022 LR3 HK -6T 3A 0O
00190707002138NeoLucent Plus .022 LL3 HK -11T 7A 2MO
00190707002121NeoLucent Plus .022 LR3 HK -11T 7A 2MO
00190707002114NeoLucent Plus .022 UL 4/5 HK -7T 0A 2DO
00190707002107NeoLucent Plus .022 UR 4/5 HK -7T 0A 2DO
00190707002091NeoLucent Plus .022 UL 4/5 HK -7T 0A 0O
00190707002084NeoLucent Plus .022 UR 4/5 HK -7T 0A 0O
00190707002077NeoLucent Plus .022 UL3 HK -7T 8A 0O
00190707002060NeoLucent Plus .022 UR3 HK -7T 8A 0O
00190707002053NeoLucent Plus .022 UL3 HK -2T 13A 4MO
00190707002046NeoLucent Plus .022 UR3 HK -2T 13A 4MO
00190707002039NeoLucent Plus .022 LL/R 1/2 -6T 0A 0O
00190707002022NeoLucent Plus .022 LL/R 1/2 -1T 0A 0O
00190707002015NeoLucent Plus .022 UL2 10T 8A 0O
00190707002008NeoLucent Plus .022 UR2 10T 8A 0O
00190707001995NeoLucent Plus .022 UL2 8T 9A 0O
00190707001988NeoLucent Plus .022 UR2 8T 9A 0O
00190707001971NeoLucent Plus .022 UL1 17T 4A 0O
00190707001964NeoLucent Plus .022 UR1 17T 4A 0O
00190707001957NeoLucent Plus .022 UL1 12T 5A 0O
00190707001940NeoLucent Plus .022 UR1 12T 5A 0O
00190707001933NeoLucent Plus .018 Kit U/L 5X5 Roth HKS
00190707001926NeoLucent Plus .018 Kit U/L 5X5 MC HKS
00190707001919NeoLucent Plus .018 LL5 HK -22T 0A 4DO
00190707001902NeoLucent Plus .018 LR5 HK -22T 0A 4DO
00190707001896NeoLucent Plus .018 LL5 HK -17T 2A 0O
00190707001889NeoLucent Plus .018 LR5 HK -17T 2A 0O
00190707001872NeoLucent Plus .018 LL4 HK -17T 0A 4DO
00190707001865NeoLucent Plus .018 LR4 HK -17T 0A 4DO
00190707001858NeoLucent Plus .018 LL4 HK -12T 2A 0O
00190707001841NeoLucent Plus .018 LR4 HK -12T 2A 0O
00190707001834NeoLucent Plus .018 LL3 HK -6T 3A 0O
00190707001827NeoLucent Plus .018 LR3 HK -6T 3A 0O
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.