AccessGUDID - DEVICE: Barricaid® Visible Light Cure Periodontal Surgical Dressing (D0026390524)

GUDID

Device Identifier (DI) Information

Brand Name: Barricaid® Visible Light Cure Periodontal Surgical Dressing
Version or Model: 639052
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 639052
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026390524
Issuing Agency: HIBCC
Commercial Distribution End Date: May 30, 2024
Device Count: 4
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Barricaid® Visible Light Cure Periodontal Surgical Dressing 4 Syringe Units

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864720	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: One units containing four syringes (4g each)

Device Record Status

Public Device Record Key: 3f497d6e-351c-4d55-950d-76e02f425723
Public Version Date: May 30, 2024
Public Version Number: 2
DI Record Publish Date: July 12, 2019