NeoCrystal

GUDID 00190707003289

NeoCrystal .022 Kit U/L 3x3 RothHKQ-PK

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707003289
• NIH Device Record Key: d7ebfd61-66c8-4a9d-8f94-ff94c64dcf03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoCrystal
• Version Model Number: 714-396Q
• 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: true
• 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	00190707003289 [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 [NeoCrystal]

• 00190707005214: NeoCrystal .018 Kit U/L 5x5 MC HK
• 00190707003357: NeoCrystal .022 Kit U/L 5x5 Roth HKS
• 00190707003340: NeoCrystal .022 Kit U/L 5x5 Roth HKS
• 00190707003333: NeoCrystal™/Maestro® .022 Kit U/L 5x5 MC HKS
• 00190707003326: NeoCrystal .022 Kit U/L 5x5 MC HKS
• 00190707003302: NeoCrystal .022 Kit U/L 5x5 Roth HK
• 00190707003296: NeoCrystal .022 Kit U/L 5x5 MC HK
• 00190707003289: NeoCrystal .022 Kit U/L 3x3 RothHKQ-PK
• 00190707003272: NeoCrystal .022 LL5 HK -22T 0A 4DO
• 00190707003265: NeoCrystal .022 LL5 -22T 0A 4DO
• 00190707003258: NeoCrystal .022 LR5 HK -22T 0A 4DO
• 00190707003241: NeoCrystal .022 LR5 -22T 0A 4DO
• 00190707003234: NeoCrystal .022 LL5 -17T 2A 0O
• 00190707003227: NeoCrystal .022 LL5 -17T 2A 0O
• 00190707003210: NeoCrystal .022 LR5 HK -17T 2A 0O
• 00190707003203: NeoCrystal .022 LR5 -17T 2A 0O
• 00190707003197: NeoCrystal .022 LL4 HK -17T 0A 4DO
• 00190707003180: NeoCrystal .022 LL4 -17T 0A 4DO
• 00190707003173: NeoCrystal .022 LR4 HK -17T 0A 4DO
• 00190707003166: NeoCrystal .022 LR4 -17T 0A 4DO
• 00190707003159: NeoCrystal .022 LL4 HK -12T 2A 0O
• 00190707003142: NeoCrystal .022 LL4 -12T 2A 0O
• 00190707003135: NeoCrystal .022 LR4 -12T 2A 0O
• 00190707003128: NeoCrystal .022 LR4 -12T 2A 0O
• 00190707003111: NeoCrystal .022 LL3 HK -6T 3A 0O
• 00190707003104: NeoCrystal .022 LR3 HK -6T 3A 0O
• 00190707003098: NeoCrystal .022 LL3 HK -11T 7A 2MO
• 00190707003081: NeoCrystal .022 LR3 HK -11T 7A 2MO
• 00190707003074: NeoCrystal .022 UL 4/5 -7T 0A 2DO
• 00190707003067: NeoCrystal .022 UL 4/5 -7T 0A 2DO
• 00190707003050: NeoCrystal .022 UR 4/5 -7T 0A 2DO
• 00190707003043: NeoCrystal .022 UR 4/5 -7T 0A 2DO
• 00190707003036: NeoCrystal .022 UL 4/5 HK -7T 0A 0O
• 00190707003029: NeoCrystal .022 UL 4/5 -7T 0A 0O
• 00190707003012: NeoCrystal .022 UR 4/5 HK -7T 0A 0O
• 00190707003005: NeoCrystal .022 UR 4/5 -7T 0A 0O
• 00190707002992: NeoCrystal .022 UL3 HK -7T 8A 0O
• 00190707002985: NeoCrystal .022 UR3 HK -7T 8A 0O
• 00190707002978: NeoCrystal .022 UL3 HK -2T 13A 4MO
• 00190707002961: NeoCrystal .022 UR3 HK -2T 13A 4MO
• 00190707002954: NeoCrystal .022 LL/R 1/2 -6T 0A 0O
• 00190707002947: NeoCrystal .022 LL/R 1/2 -1T 0A 0O
• 00190707002930: NeoCrystal .022 UL2 10T 8A 0O
• 00190707002923: NeoCrystal .022 UR2 10T 8A 0O
• 00190707002916: NeoCrystal .022 UL2 8T 9A 0O
• 00190707002909: NeoCrystal .022 UR2 8T 9A 0O
• 00190707002893: NeoCrystal .022 UL1 17T 4A 0O
• 00190707002886: NeoCrystal .022 UR1 17T 4A 0O
• 00190707002879: NeoCrystal .022 UL1 12T 5A 0O
• 00190707002862: NeoCrystal .022 UR1 12T 5A 0O