Meta P&Bond - Meta P&Bond is a wet bond adhesive system that is - Meta Biomed Co., Ltd.

Duns Number:688322841

Device Description: Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Meta P&Bond

Version/Model Number

9410

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

ca5f9487-85ea-40cd-b0a7-90abed813929

Public Version Date

October 18, 2021

Public Version Number

4

DI Record Publish Date

November 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"META BIOMED CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1335
2 A medical device with a moderate to high risk that requires special controls. 284