CERAMIC BRACKET ICERAM-P ROTH 0.018 - L3R(43) - 1UN

GUDID 07908611215666

CERAMIC BRACKET ICERAM-P ROTH 0.018 - L3R(43) - 1UN

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic bracket, ceramic

• Primary Device ID: 07908611215666
• NIH Device Record Key: 3cc77246-2680-4dbd-8f40-8d125cde95c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMIC BRACKET ICERAM-P ROTH 0.018 - L3R(43) - 1UN
• Version Model Number: 10.92.1143
• 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	07908611215666 [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

• 07898488902465 - CERAMIC BRACKET ICERAM ROTH 0.018 - U1L(21) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - U1L(21) - 1UN
• 07898488902472 - CERAMIC BRACKET ICERAM ROTH 0.018 - U2L(22) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - U2L(22) - 1UN
• 07898488902489 - CERAMIC BRACKET ICERAM ROTH 0.018 - U3L(23) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - U3L(23) - 1UN
• 07898488902496 - CERAMIC BRACKET ICERAM ROTH 0.018 - U45L(24/25) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - U45L(24/25) - 1UN
• 07898488902502 - CERAMIC BRACKET ICERAM ROTH 0.018 - L5R(45) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - L5R(45) - 1UN
• 07898488902519 - CERAMIC BRACKET ICERAM ROTH 0.018 - L4R(44) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - L4R(44) - 1UN
• 07898488902526 - CERAMIC BRACKET ICERAM ROTH 0.018 - L3R(43) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - L3R(43) - 1UN
• 07898488902533 - CERAMIC BRACKET ICERAM ROTH 0.018 - L12RL(31/32/41/42) - 1UN: 2025-12-24 CERAMIC BRACKET ICERAM ROTH 0.018 - L12RL(31/32/41/42) - 1UN