CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN

GUDID 07898488902441

CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic bracket, ceramic

• Primary Device ID: 07898488902441
• NIH Device Record Key: 8e891e43-dcf4-49a4-8fc0-2ee8e59e0e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN
• Version Model Number: 10.80.1112
• Company DUNS: 898330003
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• Device Count: 1
• DM Exempt: false
• 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: true
• 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	07898488902441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222847

FDA Product Code

• NJM: Bracket, Ceramic, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

• 07898488900706 - CERAMIC BRACKET ICERAM ROTH 0.018 - 1 SET: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - 1 SET
• 07898488902427 - CERAMIC BRACKET ICERAM ROTH 0.018 - U45R(14/15) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - U45R(14/15) - 1UN
• 07898488902434 - CERAMIC BRACKET ICERAM ROTH 0.018 - U3R(13) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - U3R(13) - 1UN
• 07898488902441 - CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN: 2025-12-19CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN
• 07898488902441 - CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN
• 07898488902458 - CERAMIC BRACKET ICERAM ROTH 0.018 - U1R(11) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - U1R(11) - 1UN
• 07908611215536 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - 1 SET: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - 1 SET
• 07908611215543 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - U1R(11) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - U1R(11) - 1UN
• 07908611215550 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - U2R(12) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - U2R(12) - 1UN