Absolute Dentin™ S301

GUDID M595S3010

Absolute Dentin™ 50ml - Tooth Shade

PARKELL, INC.

Dental composite resin

• Primary Device ID: M595S3010
• NIH Device Record Key: 3413aa21-d19b-44ac-bdf6-dd8d96dd2914
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Absolute Dentin™
• Version Model Number: S301
• Catalog Number: S301
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S3010 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Absolute Dentin™]

• 00810000525065: Absolute Dentin™ 50ml - Blue
• 00810000525034: Absolute Dentin™ 50ml - Tooth Shade
• 00810000525027: Absolute Dentin™ 50ml - Arctic White
• 00810000525010: Absolute Dentin™ - LV 5ml Syringe (TOOTH SHADE)
• 00810000525003: Absolute Dentin™ - LV 5ml Syringe (WHITE SHADE)
• M595S3070: Absolute Dentin™ 50ml - Blue
• M595S3051: 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
• M595S3041: 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
• M595S3010: Absolute Dentin™ 50ml - Tooth Shade
• M595S3000: Absolute Dentin™ 50ml - White
• 10810000525055: 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
• 10810000525048: 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
• 00810000525560: Absolute Dentin™ 50ml - Blue for Korea
• 00810000525553: Absolute Dentin™ 50ml - Tooth Shade for Korea
• 00810000525546: Absolute Dentin™ 50ml - Arctic White for Korea
• 00810000525614: 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)(Korea)
• 00810000525607: 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) (Korea)
• 10810000526939: White Root Canal Tip for Use on S334 Mixing Tip (Pkg. of 50 pcs.)
• 10810000526922: Mixing Tip with Brown Base for 5ml Absolute Dentin™ Plus (Pkg. of 30 pcs.)
• 10810000526885: Dark Grey Intraoral Tip for Use on S302 Tip (Pkg. of 50 pcs.)
• 10810000526878: Yellow Intraoral Tip for Use on S302 Mixing Tip (Pkg. of 50 pcs.)
• 10810000526861: Mixing Tip with Yellow Base for 50ml Absolute Dentin™, Mach-2®, Mach-SLO™ & SHARP™ Wash (