C&B METABOND® S398

GUDID 00810000529223

‘B’ Quick Base 10ml. for C&B METABOND®

PARKELL, INC.

Dental composite resin

• Primary Device ID: 00810000529223
• NIH Device Record Key: ecad8a44-f507-48eb-8477-e9af1b2e0e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C&B METABOND®
• Version Model Number: S398
• Catalog Number: S398
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring product to room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring product to room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring product to room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring product to room temperature before use.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store all components tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, do not freeze. Store catalyst syringe at room temp. Bring product to room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529223 [Primary]

FDA Product Code

• EMA: Cement, Dental

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: 2018-12-24
• Device Publish Date: 2018-11-23

On-Brand Devices [C&B METABOND®]

• 00810000529230: L-Powder Clear 3 grams for C&B METABOND®
• 00810000529223: ‘B’ Quick Base 10ml. for C&B METABOND®
• 00810000529216: L-Radiopaque Tooth Shade Powder 5grams for C&B METABOND®
• 00810000529209: Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
• 00810000529193: ‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®
• 00810000529162: C&B METABOND® Adhesive Cement System
• 00810000529070: ‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®
• M595S3950: Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
• 00810000529186: Ceramic Mixing Dish for C&B MetaBond®
• 00810000529643: Measuring Scoops for C&B MetaBond® Powder