Who else makes this device?

Name: OrthoMTA
Brand: OrthoMTA

Dental › ProstheticResin, Root Canal Filling

OrthoMTA

OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely infected canal, and re-endo of acute periapical abscess.…

Registry build 21.09.26

OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely infected canal, and re-endo of acute periapical abscess. Furthermore, OrthoMTA has a wide variety of clinical indications such as for apexification, repair of root perforations, and internal root resporption.

4manufacturers in China registered for this device type

2catalogue numbers in this listing

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 OrthoMTA
Listed by	BioMTA, South Korea
FDA product code	KIF
Device type	Resin, Root Canal Filling
Device class	Class 2
Regulation	21 CFR 872.3820
Establishment	Manufacturer
510(k)	K102575
Record published	2017-06-22
Record revised	2024-04-10 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for OrthoMTA
Catalogue number	Size	Status
OM05		In distribution
OM50		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
K132825	2014-04-10

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.