NeoCrystal

GUDID 00190707003326

NeoCrystal .022 Kit U/L 5x5 MC HKS

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: 00190707003326
• NIH Device Record Key: 349b77f3-c3f7-47d6-9a4e-f477d6ff9f38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoCrystal
• Version Model Number: 714-399MCQ
• 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	00190707003326 [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