Pain-Free™ S386

GUDID M595S3860

Pain-Free™-F Desensitizer with Fluoride

PARKELL, INC.

Dental coating, tooth-desensitizing

• Primary Device ID: M595S3860
• NIH Device Record Key: 6151587a-9724-437d-a989-d112afb1c4f3
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pain-Free™
• Version Model Number: S386
• Catalog Number: S386
• 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 *Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S3860 [Primary]

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 4
• Public Version Date: 2019-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Pain-Free™]

• M595S3860: Pain-Free™-F Desensitizer with Fluoride
• 10810000529619: Pain-Free™ Gel Dentin Desensitizer
• 10810000526960: Gel Application Tips (Pain-Free™ Gel, Etching Gel)