AH Plus Bioceramic Sealer

1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from…

Registry build 21.09.26

1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. 2. Principle of operation: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties. 3. Storage conditions: 1) The product must be stored at room temperature (15 – 25°C) avoiding high temperature and humidity. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture.

4manufacturers in China registered for this device type
2catalogue numbers in this listing
7510(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 AH Plus Bioceramic Sealer
Listed by Maruchi, 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) K212229
Record published 2023-06-23
Record revised 2024-03-19 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 15 to 25 °C

Catalogue Numbers

Catalogue numbers for AH Plus Bioceramic Sealer
Catalogue number Size Status
Syringe Refill In distribution
Starter Kit 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
K213757 2023-02-14
K212229 2021-08-13
K202015 2021-03-24
K170175 2018-02-26
K133042 2014-05-12
K133054 2014-05-12
K112078 2012-03-19

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer