SEcure® S271

GUDID 00810000529520

SEcure® Self-Etch Primer 3ml

PARKELL, INC.

Dental composite resin

• Primary Device ID: 00810000529520
• NIH Device Record Key: 1d07d393-e05f-4df3-98ec-9abe2f2ba1a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEcure®
• Version Model Number: S271
• Catalog Number: S271
• Company DUNS: 009900424
• Company Name: PARKELL, 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The Secure Primer must be refrigerated at all times when not in use! Failure to refrigerate will cause the primer to thicken and darken. Avoid excessive heat, sunlight and moisture.
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529520 [Primary]

FDA Product Code

• EMA: Cement, Dental

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: 2018-12-24
• Device Publish Date: 2018-11-23

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• 00810000529520: SEcure® Self-Etch Primer 3ml
• 00810000529513: SEcure® Resin Cement System Kit with Translucent Shade
• M595S2740: SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips)
• M595S2730: SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips)
• M595S2720: SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips)
• M595S2710: SEcure® Self-Etch Primer 3ml
• M595S2700: SEcure® Resin Cement System Kit with Translucent Shade
• 10810000526847: Mixing Tip with Brown Base for SEcure® (Pkg. of 30 pcs.)