NeoCrystal Plus

GUDID 00190707006921

NeoCrystal Plus .022 LL3 HK 0T 3A

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 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: 00190707006921
• NIH Device Record Key: 70e127fa-a74a-4753-82a2-4da09d3fa199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoCrystal Plus
• Version Model Number: 715-372HK-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	00190707006921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073045

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [NeoCrystal Plus]

• 00190707007126: NeoCrystal Plus .022 Kit U/L 5x5 Roth HKS
• 00190707007119: NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HKS
• 00190707007102: NeoCrystal Plus .022 Kit U/L 5x5 Roth HK
• 00190707007096: NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HK
• 00190707007089: NeoCrystal Plus .022 LL5 HK -21T 0A
• 00190707007072: NeoCrystal Plus .022 LL5 -21T 0A
• 00190707007065: NeoCrystal Plus .022 LR5 HK -21T 0A
• 00190707007058: NeoCrystal Plus .022 LR5 -21T 0A
• 00190707007041: NeoCrystal Plus .022 LL5 -17T 2A
• 00190707007034: NeoCrystal Plus .022 LL5 -17T 2A
• 00190707007027: NeoCrystal Plus .022 LR5 HK -17T 2A
• 00190707007010: NeoCrystal Plus .022 LR5 -17T 2A
• 00190707007003: NeoCrystal Plus .022 LL4 HK -17T 0A
• 00190707006990: NeoCrystal Plus .022 LL4 -17T 0A
• 00190707006983: NeoCrystal Plus .022 LR4 HK -17T 0A
• 00190707006976: NeoCrystal Plus .022 LR4 -17T 0A
• 00190707006969: NeoCrystal Plus .022 LL4 HK -12T 2A
• 00190707006952: NeoCrystal Plus .022 LL4 -12T 2A
• 00190707006945: NeoCrystal Plus .022 LR4 -12T 2A
• 00190707006938: NeoCrystal Plus .022 LR4 -12T 2A
• 00190707006921: NeoCrystal Plus .022 LL3 HK 0T 3A
• 00190707006914: NeoCrystal Plus .022 LR3 HK 0T 3A
• 00190707006907: NeoCrystal Plus .022 LL3 HK -11T 7A
• 00190707006891: NeoCrystal Plus .022 LR3 HK -11T 7A
• 00190707006884: NeoCrystal Plus .022 UL 4/5 HK -7T 0A
• 00190707006877: NeoCrystal Plus .022 UL 4/5 -7T 0A
• 00190707006860: NeoCrystal Plus .022 UR 4/5 HK -7T 0A
• 00190707006853: NeoCrystal Plus .022 UR 4/5 -7T 0A
• 00190707006846: NeoCrystal Plus .022 UL 4/5 HK -7T 0A
• 00190707006839: NeoCrystal Plus .022 UL 4/5 -7T 0A
• 00190707006822: NeoCrystal Plus .022 UR 4/5HK -7T 0A
• 00190707006815: NeoCrystal Plus .022 UR 4/5 -7T 0A
• 00190707006808: NeoCrystal Plus .022 UL3 HK - 0T 8A
• 00190707006792: NeoCrystal Plus .022 UR3 HK - 0T 8A
• 00190707006785: NeoCrystal Plus .022 UL3 HK -2T 8A
• 00190707006778: NeoCrystal Plus .022 UR3 HK -2T 8A
• 00190707006761: NeoCrystal Plus .022 LL/R 1/2 -6T 0A
• 00190707006754: NeoCrystal Plus .022 LL/R 1/2 0T 0A
• 00190707006747: NeoCrystal Plus .022 UL2 10T 8A
• 00190707006730: NeoCrystal Plus .022 UR2 10T 8A
• 00190707006723: NeoCrystal Plus .022 UL2 8T 9A
• 00190707006716: NeoCrystal Plus .022 UR2 8T 9A
• 00190707006709: NeoCrystal Plus .022 UL1 17T 4A
• 00190707006693: NeoCrystal Plus .022 UR1 17T 4A
• 00190707006686: NeoCrystal Plus .022 UL1 11T 5A
• 00190707006679: NeoCrystal Plus .022 UR1 11T 5A
• 00190707006662: NeoCrystal Plus .018 Kit U/L 5x5 Roth HKS
• 00190707006655: NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HKS
• 00190707006648: NeoCrystal Plus .018 Kit U/L 5x5 Roth HK
• 00190707006631: NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HK