Nanodent 0001

GUDID B13200010

Tooth Desensitizer

PHOENIX DENTAL, INC.

Dental coating, tooth-desensitizing, home-use

• Primary Device ID: B13200010
• NIH Device Record Key: fd84f6ab-1bdb-4c65-9ce4-6560255a2bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nanodent
• Version Model Number: 0001
• Catalog Number: 0001
• Company DUNS: 004701368
• Company Name: PHOENIX DENTAL, 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: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B13200010 [Primary]

FDA Product Code

• LBH: Varnish, Cavity

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: 2022-07-11
• Device Publish Date: 2022-07-01

Devices Manufactured by PHOENIX DENTAL, INC.

• B13200010 - Nanodent: 2022-07-11Tooth Desensitizer
• B13200010 - Nanodent: 2022-07-11 Tooth Desensitizer
• B1321002900 - Super Seal: 2019-02-07 Potassium oxalate based film forming acid resistant liner and desensitizer.
• B1321002910 - Super Seal: 2019-02-07 Potassium oxalate based film forming acid resistant liner and desensitizer.
• B1321002940 - Super Seal: 2019-02-07 Potassium oxalate based film forming acid resistant liner and desensitizer.
• B1321002950 - Super Seal: 2019-02-07 Potassium oxalate based film forming acid resistant liner and desensitizer.
• B1321002980 - Super Seal: 2019-02-07 Potassium oxalate based film forming acid resistant liner and desensitizer.