HyperFIL® S235

GUDID 00810000525737

Hyperfil® 3ml Enamel Shade

PARKELL, INC.

Dental composite resin

• Primary Device ID: 00810000525737
• NIH Device Record Key: 84f2624c-38f3-48c5-8f79-723bed4f5297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperFIL®
• Version Model Number: S235
• Catalog Number: S235
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525737 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2024-03-11
• Device Publish Date: 2024-03-01

On-Brand Devices [HyperFIL®]

• 00810000525737: Hyperfil® 3ml Enamel Shade
• 00810000525720: Hyperfil® 3ml Universal Shade