Meta P&Bond

GUDID 08806387894100

Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements. It is useful as a primer for use with other methacrylate cements. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite to composite, and composite to metal/amalgam. Meta P&Bond is packaged with Microbrush accessories.

Meta Biomed Co., Ltd.

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Primary Device ID08806387894100
NIH Device Record Keyca5f9487-85ea-40cd-b0a7-90abed813929
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeta P&Bond
Version Model Number9410
Company DUNS688322841
Company NameMeta Biomed Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806387894100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-13
Device Publish Date2018-11-19

On-Brand Devices [Meta P&Bond]

08806387894100Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bondin
08806387892212Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bondin

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