HIGH-WAVE 1141116

GUDID D8451141116

HIGH-WAVE, ORI, 454 g

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451141116
• NIH Device Record Key: 7e49adf5-3e29-4300-bbff-808da22c1965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGH-WAVE
• Version Model Number: 1141116
• Catalog Number: 1141116
• 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	D8451141116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011762

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 [HIGH-WAVE]

• D8451142200: HIGH-WAVE LIQUID, 1 L
• D8451142100: HIGH-WAVE LIQUID, 250 ml
• D8451141317: HIGH-WAVE, VIR, 11.3 kg
• D8451141316: HIGH-WAVE, ORI, 11.3 kg
• D8451141309: HIGH-WAVE, CUSTOM, 11.3 kg
• D8451141307: HIGH-WAVE, MDP, 11.3 kg
• D8451141302: HIGH-WAVE, LPL, 11.3 kg
• D8451141217: HIGH-WAVE, VIR, 2.3 kg
• D8451141216: HIGH-WAVE, ORI, 2.3 kg
• D8451141207: HIGH-WAVE, MDP, 2.3 kg
• D8451141202: HIGH-WAVE, LPL, 2.3 kg
• D8451141117: HIGH-WAVE, VIR, 454 g
• D8451141116: HIGH-WAVE, ORI, 454 g
• D8451141107: HIGH-WAVE, MDP, 454 g
• D8451141102: HIGH-WAVE, LPL, 454 g