Barricaid® Visible Light Cure Periodontal Surgical Dressing

Basic Information

• Brand Name: Barricaid® Visible Light Cure Periodontal Surgical Dressing
• Primary DI: D0026390521
• Version / Model: 639052
• Catalog Number: 639052
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2019-07-15
• Public Version Status: Update
• Public Device Record Key: 0ac49fa3-c0ec-472c-97df-99c4c07d3294
• Distribution End Date: 2019-07-12

Device Description

Barricaid® Visible Light Cure Periodontal Surgical Dressing - 9 cartons or 4 Syringe Units

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	CEMENT, DENTAL	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35573	Clinical periodontal dressing	A dental material intended to be used during periodontal procedures to facilitate periodontal tissue healing by providing mechanical, chemical, and/or thermal protection to wounded tissue after surgery or disease, and/or by functioning as a barrier for the prevention of bacterial infiltration in a periodontal pocket after root surface debridement (RSD) and/or planing and root scaling. Some types may adhere to teeth and gums and be used to secure medications, temporary prostheses, and loose teeth. It is available in various forms (e.g., gel in a syringe, fluid in a dispenser with mixing nozzle, substance mixed chairside into a pliable paste). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0026390521	HIBCC
Unit of Use	D0026390520	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K864720	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Three units each containing 12 (4g) Syringes

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius