DEVICE: PeriAcryl® (D795010)

Download: XML | JSON

Device Identifier (DI) Information

PeriAcryl®
P-ACRYLU(V)
P-ACRYLU(V)
Glustich Inc
D795010
HIBCC
1
PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Clinical periodontal dressing A dental material intended to be used in a clinical setting to cover wounded periodontal tissue to accelerate healing. It is typically a two-component substance that is mixed chairside into a pliable paste, sometimes with eugenol, that will adhere to teeth and gums. It is used to protect a wound(s) against mechanical, chemical, and thermal irritations after periodontal surgery, periodontal disease, and infections. It may also be used in the mouth to secure medications, temporary prostheses, and loose teeth. It may be available in a dispenser with mixing nozzle. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EMA Cement, Dental
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
February 06, 2017

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D795013 12 D795010 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE