DEVICE: PeriAcryl® (D795010)

Device Identifier (DI) Information

PeriAcryl®
P-ACRYLU(V)
In Commercial Distribution
P-ACRYLU(V)
Glustich Inc
D795010
HIBCC

1
201637158 *Terms of Use
PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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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 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.
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FDA Product Code

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Product Code Product Code Name
EMA Cement, Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

99ed951b-c835-4c63-9ac8-9dff525ae5de
May 23, 2018
3
February 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D795013 12 D795010 In Commercial Distribution BOX
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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