DENTCA Crown and Bridge

GUDID 00856551007421

1kg DENTCA Crown and Bridge - A3

DENTCA, INC.

Temporary dental crown/bridge resin

• Primary Device ID: 00856551007421
• NIH Device Record Key: 995a709a-7e56-47af-b4df-9573844683f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTCA Crown and Bridge
• Version Model Number: DENTCA Crown and Bridge
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00856551007421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192806

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2021-11-08
• Device Publish Date: 2021-10-29

On-Brand Devices [DENTCA Crown and Bridge]

• 00856551007469: 1kg DENTCA Crown and Bridge - BL1
• 00856551007452: 1kg DENTCA Crown and Bridge - B2
• 00856551007445: 1kg DENTCA Crown and Bridge - B1
• 00856551007438: 1kg DENTCA Crown and Bridge - A3.5
• 00856551007421: 1kg DENTCA Crown and Bridge - A3
• 00856551007414: 1kg DENTCA Crown and Bridge - A2
• 00856551007407: 1kg DENTCA Crown and Bridge - A1