DENTCA Base Hi-Impact

GUDID 00856551007575

DENTCA Base Hi-Impact - Light Pink - 1kg

DENTCA, INC.

Dental appliance fabrication material, resin

• Primary Device ID: 00856551007575
• NIH Device Record Key: 7ae9b322-6d19-4ac2-ba3f-8ac65bee9292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTCA Base Hi-Impact
• Version Model Number: DENTCA Base Hi-Impact
• Company DUNS: 022455143
• Company Name: DENTCA, INC.
• 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: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com

Device Dimensions

• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856551007575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220042

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [DENTCA Base Hi-Impact]

• 00856551007599: DENTCA Base Hi-Impact - Dark Pink - 1kg
• 00856551007582: DENTCA Base Hi-Impact - Reddish Pink - 1kg
• 00856551007575: DENTCA Base Hi-Impact - Light Pink - 1kg
• 00856551007568: DENTCA Base Hi-Impact - Original Pink - 1kg