Meta P&Bond

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…

Registry build 21.09.26

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.

6manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (2), Liaoning (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KLE
Manufacturer City Province Registered as Device types
Liaoning Upcera Co., Ltd. Benxi Liaoning Contract manufacturer 10
Shenzhen Upcera Digital Dental Technology Co., Ltd. Shenzhen Guangdong Exporter 10
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7
CAO (China) Medical Equipment Company, Limited Langfang Hebei Contract manufacturer 6
Sincera Technology (Changchun) Co., Ltd. Changchun Jilin Manufacturer 2
Sino-Dentex Co., Ltd. Changchun Jilin Manufacturer 2

Record

Regulatory record for Meta P&Bond
Listed by Meta Biomed Co., Ltd., South Korea
FDA product code KLE
Device type Agent, Tooth Bonding, Resin
Device class Class 2
Regulation 21 CFR 872.3200
Establishment Repacker / relabeller, Private-label distributor, Manufacturer
Record published 2018-11-19
Record revised 2024-02-16 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Meta P&Bond
Catalogue number Size Status
9410 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epic® Parkell, Inc. 22
All-Bond Universal Bisco, Inc. 18
Henry Schein Henry Schein, Inc. 16
Peak Universal Bond Ultradent Products Inc. 16
Brush&Bond® Parkell, Inc. 16
All-Bond 2 Bisco, Inc. 15
The Orthodontic Store Young Innovations Inc. 15
All-Bond 3 Bisco, Inc. 13
Scotchbond™ Universal 3M Deutschland GmbH 13
Select HV Etch w/BAC Bisco, Inc. 12
Prelude Danville Materials, LLC 12
Jade Dharma Research, Inc. 12

Showing 12 of 609. All products under Agent, Tooth Bonding, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230009 2023-03-03
K180802 2018-08-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer