Who else makes this device?

Name: MTA-Fillapex
Brand: MTA-Fillapex

Dental › ProstheticResin, Root Canal Filling

MTA-Fillapex

Bioceramic Root Canal Sealer - MTA-Fillapex 4g MTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity,…

Registry build 21.09.26

Bioceramic Root Canal Sealer – MTA-Fillapex 4g MTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures.

4manufacturers in China registered for this device type

3catalogue numbers in this listing

5510(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 MTA-Fillapex
Listed by	Angelus Industria DE Produtos Odontologicos S/A, Brazil
FDA product code	KIF
Device type	Resin, Root Canal Filling
Device class	Class 2
Regulation	21 CFR 872.3820
Record published	2019-08-16
Record revised	2018-03-29 (version 2)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for MTA-Fillapex
Catalogue number	Size	Status
MTA-Fillapex 4g		In distribution
MTA-FILLAPEX 12g		In distribution
MTA-Fillapex 30g		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
K201222	2021-02-11
K190537	2019-12-12
K180199	2019-01-04
K180185	2018-08-31
K172701	2018-01-04

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.