Ultra SEP

GUDID D798USEPUSAM0

1 single Unidose Ultra SEP

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798USEPUSAM0
• NIH Device Record Key: ae218d84-bb9b-467c-8e42-2263aa851b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra SEP
• Version Model Number: USEPUSAM
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798USEPU501 [Primary]
HIBCC	D798USEPUSAM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210945

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [Ultra SEP]

• D798USEPUSAM0: 1 single Unidose Ultra SEP
• D798USEP0: 6 ml bottle Ultra SEP
• D798USEPRK0: Ultra SEP Kit
• D798USEP2ML0: Ultra SEP 2ML