HyperFIL™ S321

GUDID M595S3210

HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus 10ml Dispensing Gun & Mixing Tips)

PARKELL, INC.

Dental composite resin

• Primary Device ID: M595S3210
• NIH Device Record Key: 1d9a8009-a7c3-45d4-971c-26e3ea530d77
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HyperFIL™
• Version Model Number: S321
• Catalog Number: S321
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S3210 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [HyperFIL™]

• 00810000525249: 10ml Universal Shade HyperFIL™ - DC (Dual-Cure)
• 00810000525232: 10ml Enamel Shade HyperFIL™ - DC (Dual-Cure)
• 00810000525225: HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus dispensing gun)
• 00810000525218: HyperFIL™ HAp Universal Shade
• 00810000525201: HyperFIL™ HAp Enamel Shade
• M595S3260: 10ml Universal Shade HyperFIL™-DC (Dual-Cure)
• M595S3230: 10ml Enamel Shade HyperFIL™-DC (Dual-Cure)
• M595S3210: HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus 10ml Dispensing Gun & Mixin
• 10810000526915: White Intraoral Tip for Use on S328 Mixing Tip (Pkg. of 50 pcs.)
• 10810000526908: Mixing Tip with Brown Base for 10ml HyperFil™ & 10ml Absolute Dentin™ (Pkg. of 30 pcs.)