Twinky Star 1686

GUDID E22116861

Coloured light-curing compmer restorative material with glitter effect.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22116861
• NIH Device Record Key: cb935ce8-ced5-4591-88de-75db1050aaba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twinky Star
• Version Model Number: 1686
• Catalog Number: 1686
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 25
• 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: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22116860 [Unit of Use]
HIBCC	E22116861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022797

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: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Twinky Star]

• E22116881: Coloured light-curing compmer restorative material with glitter effect.
• E22116871: Coloured light-curing compmer restorative material with glitter effect.
• E22116861: Coloured light-curing compmer restorative material with glitter effect.
• E22116851: Coloured light-curing compmer restorative material with glitter effect.
• E22116841: Coloured light-curing compmer restorative material with glitter effect.
• E22116831: Coloured light-curing compmer restorative material with glitter effect.
• E22116821: Coloured light-curing compmer restorative material with glitter effect.
• E22116811: Coloured light-curing compmer restorative material with glitter effect.
• E22116801: Coloured light-curing compmer restorative material with glitter effect. This kit contains 40 cap