Silhouette

GUDID 00190707007256

Silhouette .018 Kit U 5x5 Roth HK

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707007256
• NIH Device Record Key: 0ad4a2bd-5a39-455e-9a9a-b0a5328a52bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette
• Version Model Number: 2886-0482
• 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	00190707007256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922499

FDA Product Code

• EJF: BRACKET, METAL, 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 [Silhouette]

• 00190707009168: Silhouette™ .018 LL5 HK -17T 0A 0O
• 00190707009151: Silhouette™ .018 LR5 HK -17T 0A 0O
• 00190707009144: Silhouette™ .018 LL5 -17T 0A 0O
• 00190707009137: Silhouette™ .018 LR5 -17T 0A 0O
• 00190707009120: Silhouette™ .018 LL4 HK -12T 0A 0O
• 00190707009113: Silhouette™ .018 LR4 HK -12T 0A 0O
• 00190707009106: Silhouette™ .018 LL4 -12T 0A 0O
• 00190707009090: Silhouette™ .018 LR4 -12T 0A 0O
• 00190707009083: Silhouette™ .018 LL3 -6T 3A 0O
• 00190707009076: Silhouette™ .018 LR3 -6T 3A 0O
• 00190707009069: Silhouette™ .018 LL3 HK -6T 3A 0O
• 00190707009052: Silhouette™ .018 LR3 HK -6T 3A 0O
• 00190707009045: Silhouette™ .022 LL3 -6T 3A 0O
• 00190707009038: Silhouette™ .022 LR3 -6T 3A 0O
• 00190707009021: Silhouette™ .018 UL3 -7T 8A 0O
• 00190707009014: Silhouette™ .018 UR3 -7T 8A 0O
• 00190707009007: Silhouette™ .022 UL3 -7T 8A 0O
• 00190707008994: Silhouette™ .022 UR3 -7T 8A 0O
• 00190707008987: Silhouette™ .018 UR 4/5 -7T 0A 0O
• 00190707008970: Silhouette™ .018 UL 4/5 -7T 0A 0O
• 00190707008963: Silhouette™ .022 UL 4/5 -7T 0A 0O
• 00190707008956: Silhouette™ .022 LL5 -22T 0A 0O
• 00190707008949: Silhouette™ .022 LR5 -22T 0A 0O
• 00190707008932: Silhouette™ .018 LL4 HK -17T 0A 0O
• 00190707008925: Silhouette™ .022 LL4 -17T 0A 0O
• 00190707008918: Silhouette™ .022 LR4 -17T 0A 0O
• 00190707008901: Silhouette™ .018 LL3 -11T 5A 2MO
• 00190707008895: Silhouette™ .018 LR3 -11T 5A 2MO
• 00190707008888: Silhouette™ .022 LL3 -11T 5A 2MO
• 00190707008871: Silhouette™ .022 LR3 -11T 5A 2MO
• 00190707008864: Silhouette™ .018 UL3 0T 11A 4MO
• 00190707008857: Silhouette™ .018 UR3 0T 11A 4MO
• 00190707008840: Silhouette™ .022 UL3 0T 11A 4MO
• 00190707008833: Silhouette™ .022 UR3 0T 11A 4MO
• 00190707008826: Silhouette™ .018 UR 4/5 -7T 0A 0O
• 00190707008819: Silhouette™ .018 UL 4/5 -7T 0A 0O
• 00190707008802: Silhouette™ .022 UR 4/5 -7T 0A 0O
• 00190707008796: Silhouette™ .022 UL 4/5 -7T 0A 0O
• 00190707008789: Silhouette .022 Kit U/L 5x5 MC HK
• 00190707008765: Silhouette .022 Kit U/L 5x5 MC HKS
• 00190707008703: Silhouette .022 LL5 HK -17T 0A 0O
• 00190707008680: Silhouette .022 LR5 HK -17T 0A 0O
• 00190707008666: Silhouette .022 LL5 -17T 0A 0O
• 00190707008659: Silhouette .022 LR5 -17T 0A 0O
• 00190707008628: Silhouette .022 LL4 HK -12T 0A 0O
• 00190707008604: Silhouette .022 LR4 HK -12T 0A 0O
• 00190707008581: Silhouette .022 LL4 -12T 0A 0O
• 00190707008567: Silhouette .022 LR4 -12T 0A 0O
• 00190707008529: Silhouette .022 LL3 HK -6T 3A 0O
• 00190707008505: Silhouette .022 LR3 HK -6T 3A 0O