C&B METABOND® S395

GUDID 00810000529209

Enamel Etchant Gel (Red) 5ml. for C&B METABOND®

PARKELL, INC.

Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution

• Primary Device ID: 00810000529209
• NIH Device Record Key: bf282a8c-4e4d-467d-a725-1b570a95a4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C&B METABOND®
• Version Model Number: S395
• Catalog Number: S395
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 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.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529209 [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

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• 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