DP97 1001116

GUDID D8451001116

DP97, ORI, 454 g

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451001116
• NIH Device Record Key: eae7be2b-e1fe-48c2-8427-97a677565572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DP97
• Version Model Number: 1001116
• Catalog Number: 1001116
• 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	D8451001116 [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 [DP97]

• D8451001316: DP97, ORI, 11.3 kg
• D8451001309: DP97, Custom, 11.3 kg
• D8451001307: DP97, MDP, 11.3 kg
• D8451001303: DP97, RPI, 11.3 kg
• D8451001302: DP97, LPL, 11.3 kg
• D8451001300: DP97, CLR, 11.3kg
• D8451001216: DP97, ORI, 2.3 kg
• D8451001207: DP97, MDP, 2.3 kg
• D8451001202: DP97, LPL, 2.3 kg
• D8451001200: DP97, CLR, 2.3 kg
• D8451001116: DP97, ORI, 454 g
• D8451001107: DP97, MPD, 454 g
• D8451001102: DP97, LPL, 454 g
• D8451001100: DP97, CLR, 454 g