Who else makes this device?

Name: Maarc Dental -Rootfyx
Brand: Maarc Dental -Rootfyx

Dental › ProstheticResin, Root Canal Filling

Maarc Dental -Rootfyx

Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately…

Registry build 21.09.26

Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Maarc Dental -Rootfyx
Listed by	Shiva Products, India
FDA product code	KIF
Device type	Resin, Root Canal Filling
Device class	Class 2
Regulation	21 CFR 872.3820
510(k)	K240446
Record published	2024-10-02

Specifications

Specifications
MRI safety	MR Safe
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature 10 to 30 °C

Catalogue Numbers

Catalogue numbers for Maarc Dental -Rootfyx
Catalogue number	Size	Status
9107/0.5×4		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
K240446	2024-07-30

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.