AccessGUDID - DEVICE: PeriAcryl® (D795010)

GUDID

Device Identifier (DI) Information

Brand Name: PeriAcryl®
Version or Model: P-ACRYLU(V)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P-ACRYLU(V)
Company Name: Glustich Inc

Primary DI Number: D795010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201637158 *Terms of Use

Device Description: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.

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:	Yes
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 [?]
K071484	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
No Device Sizes

Device Record Status

Public Device Record Key: 99ed951b-c835-4c63-9ac8-9dff525ae5de
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: February 06, 2017