IMPACT-20 1031101

GUDID D8451031101

IMPACT-20, SPL, 454 g

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451031101
• NIH Device Record Key: 7982d5a2-8431-4c07-831a-a801fac241c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACT-20
• Version Model Number: 1031101
• Catalog Number: 1031101
• Company DUNS: 202016064
• Company Name: Denplus Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8451031101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991996

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2018-05-02

On-Brand Devices [IMPACT-20]

• D8451031317: IMPACT-20, VIR, 11.3 kg
• D8451031316: IMPACT-20, ORI, 11.3 kg
• D8451031309: IMPACT-20, CUSTOM, 11.3 kg
• D8451031307: IMPACT-20, MDP, 11.3 kg
• D8451031305: IMPACT-20, LPI, 11.3 kg
• D8451031304: IMPACT-20, SPI, 11.3 kg
• D8451031303: IMPACT-20, RPI, 11.3 kg
• D8451031302: IMPACT-20, LPL, 11.3 kg
• D8451031301: IMPACT-20, SPL, 11.3 kg
• D8451031217: IMPACT-20, VIR, 2.3 kg
• D8451031216: IMPACT-20, ORI, 2.3 kg
• D8451031207: IMPACT-20, MDP, 2.3 kg
• D8451031205: IMPACT-20, LPI, 2.3 kg
• D8451031204: IMPACT-20, SPI, 2.3 kg
• D8451031203: IMPACT-20. RPI, 2.3 kg
• D8451031202: IMPACT-20, LPL, 2.3 kg
• D8451031201: IMPACT-20, SPL, 2.3 kg
• D8451031117: IMPACT-20, VIR, 454 g
• D8451031116: IMPACT-20, ORI, 454 g
• D8451031107: IMPACT-20, MDP, 454 g
• D8451031105: IMPACT-20, LPI, 454 g
• D8451031104: IMPACT-20, SPI, 454 g
• D8451031103: IMPACT-20, RPI, 454 g
• D8451031102: IMPACT-20, LPL, 454 g
• D84510311010: Impact-20, 1 lbs, SPL
• D8451031101: IMPACT-20, SPL, 454 g