DENTCA Denture Teeth

GUDID 00856551007315

1kg DENTCA Denture Teeth - A2

DENTCA, INC.

Resin artificial teeth

• Primary Device ID: 00856551007315
• NIH Device Record Key: 463d3e2d-0926-4abc-8af5-a47a270b0010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTCA Denture Teeth
• Version Model Number: DENTCA Denture Teeth
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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	00856551007315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172398

FDA Product Code

• PZY: Additively Manufactured, Preformed, Resin Denture Tooth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-04
• Device Publish Date: 2017-07-07

On-Brand Devices [DENTCA Denture Teeth]

• 00856551007353: 1kg DENTCA Denture Teeth - B2
• 00856551007346: 1 kg DENTCA Denture Teeth - B1
• 00856551007339: 1kg DENTCA Denture Teeth - A3.5
• 00856551007322: 1kg DENTCA Denture Teeth - A3
• 00856551007315: 1kg DENTCA Denture Teeth - A2
• 00856551007308: 1kg DENTCA Denture Teeth - A1
• 00856551007360: 1kg DENTCA Denture Teeth - BL1