NeoLucent Plus

GUDID 00190707001698

NeoLucent Plus .018 UL2 10T 8A 0O

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707001698
• NIH Device Record Key: ee45c9ea-c741-4984-b744-603b59e0ee2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLucent Plus
• Version Model Number: 704-224-5
• 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	00190707001698 [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