NexTemp

GUDID 00348783000207

NexTemp Bulk Pack Opaque

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin

• Primary Device ID: 00348783000207
• NIH Device Record Key: b12099af-c1d6-48af-9349-e2f8edc1b3f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexTemp
• Version Model Number: 3001470
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00348783000207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051866

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-12-15
• Device Publish Date: 2016-09-21

On-Brand Devices [NexTemp]

• 00348783000214: NexTemp Standard Pack Opaque
• 00348783000207: NexTemp Bulk Pack Opaque