C&B METABOND® S378

GUDID 00810000529643

Measuring Scoops for C&B MetaBond® Powder

PARKELL, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 00810000529643
• NIH Device Record Key: 04f85067-79b5-4fd1-9fab-d9760590dcfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C&B METABOND®
• Version Model Number: S378
• Catalog Number: S378
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 3
• 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: false
• Serial Number: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529643 [Unit of Use]
GS1	10810000529640 [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: 2023-12-22
• Device Publish Date: 2023-12-14

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