Optyc

GUDID 00817573022557

OPTYC ROTH LAT +8T +9A 018 UR

LANCER ORTHODONTICS, INC.

Orthodontic bracket, metal

• Primary Device ID: 00817573022557
• NIH Device Record Key: acc5f5b5-59bf-40a6-aef6-ffdc4241e13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optyc
• Version Model Number: 246-411
• Company DUNS: 045545589
• Company Name: LANCER ORTHODONTICS, INC.
• 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: 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	00817573022557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902075

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: 2016-12-30

On-Brand Devices [Optyc]

• 00817573022762: OPTYC ROTH 2BIC -22T 0A 022 LOW
• 00817573022755: OPTYC ROTH 1BIC -17T 0A 022 LOW
• 00817573022748: OPTYC ROTH CUS HK -11T 5A 022 LL
• 00817573022731: OPTYC ROTH CUS HK -11T 5A 022 LR
• 00817573022724: OPTYC ROTH ANT 0T 0A 022 LOW
• 00817573022717: OPTYC ROTH BIC -7T 0A 022 UP
• 00817573022700: OPTYC ROTH CUS HK 0T +11A 022 UL
• 00817573022694: OPTYC ROTH CUS HK 0T +11A 022 UR
• 00817573022687: OPTYC ROTH LAT +8T +9A 022 UL
• 00817573022670: OPTYC ROTH LAT +8T +9A 022 UR
• 00817573022663: OPTYC ROTH CENT +12T +5A 022 UL
• 00817573022656: OPTYC ROTH CENT +12T +5A 022 UR
• 00817573022649: OPTYC ROTH 2BIC -22T 0A 018 LOW
• 00817573022632: OPTYC ROTH 1BIC -17T 0A 018 LOW
• 00817573022625: OPTYC ROTH CUS HK -11T 5A 018 LL
• 00817573022618: OPTYC ROTH CUS HK -11T 5A 018 LR
• 00817573022601: OPTYC ROTH ANT 0T 0A 018 LOW
• 00817573022595: OPTYC ROTH BIC -7T 0A 018 UP
• 00817573022588: OPTYC ROTH CUS HK 0T +11A 018 UL
• 00817573022571: OPTYC ROTH CUS HK 0T +11A 018 UR
• 00817573022564: OPTYC ROTH LAT +8T +9A 018 UL
• 00817573022557: OPTYC ROTH LAT +8T +9A 018 UR
• 00817573022540: OPTYC ROTH CENT +12T +5A 018 UL
• 00817573022533: OPTYC ROTH CENT +12T +5A 018 UR