NeoLucent Plus

GUDID 00190707002008

NeoLucent Plus .022 UR2 10T 8A 0O

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: 00190707002008
• NIH Device Record Key: f3f2e437-8e3c-47d2-9a73-cb5c4c926180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLucent Plus
• Version Model Number: 704-323-5
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707002008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110335

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NeoLucent Plus]

• 00190707005207: NeoLucent Plus/Maestro .018 Kit U/L 5x5 MC HKS
• 00190707003319: NeoLucent® Plus™ .018 Kit U/L 3x3 Roth HK
• 00190707002299: NeoLucent Plus .022 Kit U/L 5X Roth HKS
• 00190707002282: NeoLucent Plus .022 Kit U/L 5X5 Roth HKS
• 00190707002275: NeoLucent Plus .022 Kit U/L 5X5 MC HKS
• 00190707002268: NeoLucent Plus .022 Kit U/L 5x Rondeau Rx Roth HKS
• 00190707002251: NeoLucent Plus/Maestro .022 Kit U/L 5x5 Roth HKS
• 00190707002244: NeoLucent Plus/Maestro .022 Ki U/L 5x5 MC HKS
• 00190707002237: NeoLucent Plus .022 LL5 HK -22T 0A 4DO
• 00190707002220: NeoLucent Plus .022 LR5 HK -22T 0A 4DO
• 00190707002213: NeoLucent Plus .022 LL5 HK -17T 2A 0O
• 00190707002206: NeoLucent Plus .022 LR5 HK -17T 2A 0O
• 00190707002190: NeoLucent Plus .022 LL4 HK -17T 0A 4DO
• 00190707002183: NeoLucent Plus .022 LR4 HK -17T 0A 4DO
• 00190707002176: NeoLucent Plus .022 LL4 HK -12T 2A 0O
• 00190707002169: NeoLucent Plus .022 LR4 HK -12T 2A 0O
• 00190707002152: NeoLucent Plus .022 LL3 HK -6T 3A 0O
• 00190707002145: NeoLucent Plus .022 LR3 HK -6T 3A 0O
• 00190707002138: NeoLucent Plus .022 LL3 HK -11T 7A 2MO
• 00190707002121: NeoLucent Plus .022 LR3 HK -11T 7A 2MO
• 00190707002114: NeoLucent Plus .022 UL 4/5 HK -7T 0A 2DO
• 00190707002107: NeoLucent Plus .022 UR 4/5 HK -7T 0A 2DO
• 00190707002091: NeoLucent Plus .022 UL 4/5 HK -7T 0A 0O
• 00190707002084: NeoLucent Plus .022 UR 4/5 HK -7T 0A 0O
• 00190707002077: NeoLucent Plus .022 UL3 HK -7T 8A 0O
• 00190707002060: NeoLucent Plus .022 UR3 HK -7T 8A 0O
• 00190707002053: NeoLucent Plus .022 UL3 HK -2T 13A 4MO
• 00190707002046: NeoLucent Plus .022 UR3 HK -2T 13A 4MO
• 00190707002039: NeoLucent Plus .022 LL/R 1/2 -6T 0A 0O
• 00190707002022: NeoLucent Plus .022 LL/R 1/2 -1T 0A 0O
• 00190707002015: NeoLucent Plus .022 UL2 10T 8A 0O
• 00190707002008: NeoLucent Plus .022 UR2 10T 8A 0O
• 00190707001995: NeoLucent Plus .022 UL2 8T 9A 0O
• 00190707001988: NeoLucent Plus .022 UR2 8T 9A 0O
• 00190707001971: NeoLucent Plus .022 UL1 17T 4A 0O
• 00190707001964: NeoLucent Plus .022 UR1 17T 4A 0O
• 00190707001957: NeoLucent Plus .022 UL1 12T 5A 0O
• 00190707001940: NeoLucent Plus .022 UR1 12T 5A 0O
• 00190707001933: NeoLucent Plus .018 Kit U/L 5X5 Roth HKS
• 00190707001926: NeoLucent Plus .018 Kit U/L 5X5 MC HKS
• 00190707001919: NeoLucent Plus .018 LL5 HK -22T 0A 4DO
• 00190707001902: NeoLucent Plus .018 LR5 HK -22T 0A 4DO
• 00190707001896: NeoLucent Plus .018 LL5 HK -17T 2A 0O
• 00190707001889: NeoLucent Plus .018 LR5 HK -17T 2A 0O
• 00190707001872: NeoLucent Plus .018 LL4 HK -17T 0A 4DO
• 00190707001865: NeoLucent Plus .018 LR4 HK -17T 0A 4DO
• 00190707001858: NeoLucent Plus .018 LL4 HK -12T 2A 0O
• 00190707001841: NeoLucent Plus .018 LR4 HK -12T 2A 0O
• 00190707001834: NeoLucent Plus .018 LL3 HK -6T 3A 0O
• 00190707001827: NeoLucent Plus .018 LR3 HK -6T 3A 0O