SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive 60-052

GUDID D801SP60052B1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel and Primer. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive

• Primary Device ID: D801SP60052B1
• NIH Device Record Key: c86c680f-aaed-40db-897e-f9e43b7d8d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive
• Version Model Number: SP 60-052 B
• Catalog Number: 60-052
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-634-3047
• Email: Denise@scipharm.com
• Phone: 800-634-3047
• Email: Denise@scipharm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP60052B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831495

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

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: 2016-08-10

On-Brand Devices [SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive]

• D801SP60151: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Introductory Kit.
• D801SP6005S1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Spanish
• D801SP60055B1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Plastic Bracket Primer. 1/2 oz. Boxed.
• D801SP600551: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Plastic Bracket Primer. 1/2 oz.
• D801SP60054N1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Push Type Syringe. Non-Boxed.
• D801SP60054B1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Push Type Syringe. Boxed.
• D801SP60053CB1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive. Carpule. Boxed.
• D801SP60053C1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive. Carpule.
• D801SP60052N1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel and Primer. Non-Boxed.
• D801SP60052B1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel and Primer. Boxed.
• D801SP60051N1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive. Non-Boxed.
• D801SP60051B1: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Introductory Kit. Boxed.
• D801SP60051: CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit
• D801SP60016B1: CuRay Eclipse Visible Light-Cured Orthodontic Plastic Bracket Primer. Boxed.
• D801SP60016: CuRay Eclipse Visible Light-Cured Orthodontic Plastic Bracket Primer.