IMPACT-PLUS 1011101

GUDID D8451011101

IMPACT-PLUS, SLP, 454 g

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451011101
• NIH Device Record Key: 6752db13-2219-4a0a-bcdd-6fc26492be62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACT-PLUS
• Version Model Number: 1011101
• Catalog Number: 1011101
• 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	D8451011101 [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: 2018-04-30

On-Brand Devices [IMPACT-PLUS]

• D8451011317: IMPACT-PLUS, VIR, 11.3 kg
• D8451011316: IMPACT-PLUS, ORI, 11.3 kg
• D8451011309: IMPACT-PLUS, CUSTOM, 11.3 kg
• D8451011307: IMPACT-PLUS, MDP, 11.3 kg
• D8451011305: IMPACT-PLUS, LPI, 11.3 kg
• D8451011304: IMPACT-PLUS, SPI, 11.3 kg
• D8451011303: IMPACT-PLUS, RPI, 11.3 kg
• D8451011302: IMPACT-PLUS,LPL, 11.3 kg
• D8451011301: IMPACT-PLUS, SPL, 11.3 kg
• D8451011217: IMPACT-PLUS, VIR, 2.3 kg
• D8451011216: IMPACT-PLUD, ORI, 2.3kg
• D8451011207: IMPACT-PLUS, MDP, 2.3 kg
• D8451011205: IMPACT-PLUS, LPI, 2.3 kg
• D8451011204: iMPACT-PLUS, SPI.
• D8451011203: IMPACT-PLUS, RPI, 2.3 kg
• D8451011202: IMPACT-PLUS, LPL, 2.3 kg
• D8451011201: IMPACT-PLUS, SLP, 2.3 kg
• D8451011117: IMPACT-PLUS, VIR, 454 g
• D8451011116: IMMPACT-PLUS, ORI, 454 g
• D8451011107: IMPACT-PLUS, MDP,454 g
• D8451011105: IMPACT-PLUS, LPI, 454 g
• D8451011104: IMPACT-PLUS, SPI, 454 g
• D8451011103: IMPACT-PLUS, RPI, 454 g
• D8451011102: IMPACT-PLUS, LPL, 454 g
• D8451011101: IMPACT-PLUS, SLP, 454 g