Dentalis

GUDID 04560128312592

Endodontic sealing material, 15g Powder

NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.

Endodontic filling/sealing material

• Primary Device ID: 04560128312592
• NIH Device Record Key: 9c5cbc2c-4377-41af-a1c3-eb46d61aae47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentalis
• Version Model Number: Powder
• Company DUNS: 691229181
• Company Name: NEO DENTAL CHEMICAL PRODUCTS 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: false
• 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

Customer Support Contacts

• Phone: 253-946-0814
• Email: karin@neodental-intl.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560128312592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971642

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [Dentalis]

• 04560128312608: Endodontic sealing material, 10mL Liquid
• 04560128312592: Endodontic sealing material, 15g Powder
• 04560128312585: Endodontic sealing material, 15g Powder, 10mL Liquid