PD MTA White

PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages :…

Registry build 21.09.26

PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages : → Optimized particle size allowing homogeneous and complete wetting during mixing → Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity → No need to dry the treated site. PD MTA White properties are not decreased in a moist environment The powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure. Indications → Treatment of perforations of root canal and furcation → Treatment of internal resorption → Retrograde root canal filling after apical resection → Pulp capping → Pulpotomy → Apical plug during apexification treatment

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Guangxi (1), Beijing (1).

Chinese manufacturers registered for FDA product code KIF
Manufacturer City Province Registered as Device types
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Guilin Kevin Peter Technology Co., Ltd. Guilin Guangxi Manufacturer 13
Beijing C-Root Dental Medical Devices Co., Ltd. Beijing Beijing Manufacturer 6
Enpuno Biotechnology Co., Ltd. Changsha Hunan Manufacturer 1

Record

Regulatory record for PD MTA White
Listed by Produits dentaires S.A.
FDA product code KIF
Device type Resin, Root Canal Filling
Device class Class 2
Regulation 21 CFR 872.3820
Record published 2017-04-03
Record revised 2019-04-09 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Special storage condition: Store at room temperature; Special storage condition: Protect from light; Special storage condition: Protect from humidity

Catalogue Numbers

Catalogue numbers for PD MTA White
Catalogue number Size Status
20190 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Brasseler USA Peter Brasseler Holdings, LLC 19
Root canal repair materials Enpunuo Biotechnology Co., Ltd. 12
Diapaste Diadent Group Intl., Inc. 10
NeoMTA Plus Avalon Biomed, Inc. 10
C-Root Beijing C-Root Dental Medical Devices Co., Ltd. 10
MetaSEAL™ Parkell, Inc. 7
Henry Schein Henry Schein, Inc. 7
Grey MTA Plus Avalon Biomed, Inc. 7
EndoREZ Ultradent Products Inc. 6
Cerafill RCS Prevest Denpro Limited 6
MTA Angelus Angelus Industria DE Produtos Odontologicos S/A 5
Injectable Root Canal Bioceramic Sealer(nRoot SP) Enpunuo Biotechnology Co., Ltd. 5

Showing 12 of 204. All products under Resin, Root Canal Filling

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