Contour

GUDID 00190707003531

Contour .022 UL2 8T 9A 0O

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: 00190707003531
• NIH Device Record Key: ae4bab3d-fcf9-4eea-875f-a2be030584dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour
• Version Model Number: 303-03-5
• 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	00190707003531 [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 [Contour]

• 00190707003647: Contour .022 Kit U/L 5x5 HKS
• 00190707003630: Contour .022 Kit U 5x5 Roth
• 00190707003623: Contour .022 Kit U 3x3 Roth
• 00190707003616: Contour .022 LR3 -11T 7T 0A
• 00190707003609: Contour .022 LL3 -11T 7T 0A
• 00190707003593: Contour .022 LL/R 1/2 0T 0A 0O
• 00190707003586: Contour .022 LL/R 1/2 0T 0A 0O
• 00190707003579: Contour .022 UL/R 4/5 -7T 0A 0O
• 00190707003562: Contour .022 UR3 0T 12A 0O
• 00190707003555: Contour .022 UL3 0T 12A 0O
• 00190707003548: Contour .022 UR2 8T 9A 0O
• 00190707003531: Contour .022 UL2 8T 9A 0O
• 00190707003524: Contour .022 UR1 12T 5A 0O
• 00190707003517: Contour .022 UL1 12T 5A 0O
• 00190707003500: Contour .018 Kit L 3x3 Roth
• 00190707003494: Contour .018 Kit U 5x5 Roth
• 00190707003487: Contour .018 Kit U 3x3 Roth
• 00190707003470: Contour .018 LR3 -11T 7T 0A
• 00190707003463: Contour .018 LL3 -11T 7T 0A
• 00190707003456: Contour .018 LL/R 1/2 0T 0A 0O
• 00190707003449: Contour .018 UL/R 4/5 -7T 0A 0 0O
• 00190707003432: Contour .018 UR3 0T 12A 0O
• 00190707003425: Contour .018 UL3 0T 12A 0O
• 00190707003418: Contour .018 UR2 8T 9A 0O
• 00190707003401: Contour .018 UL2 8T 9A 0O
• 00190707003395: Contour .018 UR1 12T 5A 0O
• 00190707003388: Contour .018 UL1 12T 5A 0O