MAXAPPLICATOR II 600B-R-400

GUDID D832600BR4000

Applicators - Regular, Assorted 4 colors

PLASDENT CORPORATION

Dental material application tool, single-use

• Primary Device ID: D832600BR4000
• NIH Device Record Key: 649f3e7f-53b8-4197-b941-a47bcf50635b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXAPPLICATOR II
• Version Model Number: 600B-R-400
• Catalog Number: 600B-R-400
• Company DUNS: 190377184
• Company Name: PLASDENT CORPORATION
• Device Count: 400
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D832600BR4000 [Unit of Use]
HIBCC	D832600BR4001 [Primary]

FDA Product Code

• KXF: Applicator, Absorbent Tipped, Non-Sterile

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: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [MAXAPPLICATOR II]

• D832600BSF4000: Applicators - Super Fine, White
• D832600BR4000: Applicators - Regular, Assorted 4 colors
• D832600BF4000: Applicators - Fine, Assorted 2 colors
• D832600BA4000: Applicators - Assorted Sizes, Assorted 4 colors