Injectable Root Canal Bioceramic Sealer

GUDID 16976329180031

Enpunuo Biotechnology Co., Ltd

Hygroscopic dental cement

• Primary Device ID: 16976329180031
• NIH Device Record Key: fea7abc3-287d-48fa-b16c-d71cf42f0cc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injectable Root Canal Bioceramic Sealer
• Version Model Number: NR SP-5
• Company DUNS: 715461879
• Company Name: Enpunuo Biotechnology Co., Ltd
• 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: true
• 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	06976329180034 [Primary]
GS1	16976329180031 [Package]; Contains: 06976329180034; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240304

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [Injectable Root Canal Bioceramic Sealer]

• 16976329180048: NR SP-0.5
• 16976329180031: NR SP-5
• 16976329180024: NR SP-3
• 16976329180017: NR SP-1
• 06976329180003: NR SP-2