IMPACT-20 1031117

GUDID D8451031117

IMPACT-20, VIR, 454 g

Denplus Inc

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D8451031117
• NIH Device Record Key: 630ee7ee-20e7-414c-beaa-24d418ee7036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACT-20
• Version Model Number: 1031117
• Catalog Number: 1031117
• 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	D8451031117 [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