Who else makes this device?

Name: DIA-Root BIO MTA
Brand: DIA-Root BIO MTA

Dental › ProstheticResin, Root Canal Filling

DIA-Root BIO MTA

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end…

Registry build 21.09.26

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy.

4manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

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 DIA-Root BIO MTA
Listed by	Diadent Group Intl., Inc., Canada
FDA product code	KIF
Device type	Resin, Root Canal Filling
Device class	Class 2
Regulation	21 CFR 872.3820
Establishment	Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Record published	2021-01-27
Record revised	2023-10-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and Keep away from Sunlight.

Catalogue Numbers

Catalogue numbers for DIA-Root BIO MTA
Catalogue number	Size	Status
DIA-ROOT BIO MTA 0.5g		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K210333	2021-03-25
K200174	2020-09-18
K200175	2020-06-25
K190091	2020-03-27
K182009	2019-09-26
K182625	2019-06-03

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.