Who else makes this device?

Name: KometSeal
Brand: KometSeal

Dental › ProstheticResin, Root Canal Filling

KometSeal

KometsSeal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root…

Registry build 21.09.26

KometsSeal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

4manufacturers in China registered for this device type

1catalogue number

9510(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 KometSeal
Listed by	Meta Biomed Co., Ltd., South Korea
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
Record published	2020-03-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for KometSeal
Catalogue number	Size	Status
9483		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
K232299	2023-09-29
K230010	2023-04-13
K210904	2021-06-30
K202617	2021-04-14
K190503	2019-06-07
K190510	2019-05-29
K042769	2004-11-24
K032605	2003-10-08
K032603	2003-10-07

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.