Zirlux

ZIRLUX ML DISC OM2 98x14 Ea

Registry build 21.09.26
24manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (7), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJH
Manufacturer City Province Registered as Device types
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai Smedent Medical Instrument Co., Ltd. Shanghai Shanghai Repacker / relabeller 30
Fseven Dental Technology Zhuhai Co., Ltd. Zhuhai Guangdong Manufacturer 18
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Shen FU Arts LAB Shen Zhen Guangdong Manufacturer 15
Shenzhen HLD Dental&Technology Co., Ltd. Shenzhen Guangdong Manufacturer 14
Shenzhen Times Dental LAB Shenzhen Guangdong Manufacturer 13
Qinhuangdao Audental Metal Technology Co., Ltd. Qinhuangdao Hebei Manufacturer 11
Smile Dental Laboratory Company Limited Zhuhai Guangdong Manufacturer 11
Riton 3D Technology Co., Ltd. Guangzhou Guangdong Repacker / relabeller 9

Showing 12 of 24. All 24 manufacturers in China registered for Alloy, Metal, Base

Record

Regulatory record for Zirlux
Listed by Henry Schein, Inc., United States
FDA product code EJH
Device type Alloy, Metal, Base
Device class Class 2
Regulation 21 CFR 872.3710
Premarket notification Exempt
Record published 2016-09-24
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Zirlux
Catalogue number Size Status
9009524 In distribution
9009515 In distribution
9200092 In distribution
9200066 In distribution
9200073 In distribution
9200058 In distribution
9200048 In distribution
9200047 In distribution
9200062 In distribution
9009521 In distribution
9009517 In distribution
9200087 In distribution
9009525 In distribution
9009523 In distribution
9200097 In distribution
9200105 In distribution
9200089 In distribution
9200077 In distribution
9200055 In distribution
9200072 In distribution
9200111 In distribution
9200112 In distribution
9200113 In distribution
9200094 In distribution
9009519 In distribution
9200069 In distribution
9200085 In distribution
9200104 In distribution
9009529 In distribution
9200090 In distribution
9200091 In distribution
9200101 In distribution
9200061 In distribution
9200086 In distribution
9200084 In distribution
9200099 In distribution
9200057 In distribution
9200109 In distribution
9200082 In distribution
9200051 In distribution
9009520 In distribution
9200056 In distribution
9200063 In distribution
9009528 In distribution
9200110 In distribution
9009522 In distribution
9200088 In distribution
9200096 In distribution
9200054 In distribution
9200079 In distribution
9009518 In distribution
9009527 In distribution
9200064 In distribution
9200107 In distribution
9200046 In distribution
9009516 In distribution
9200052 In distribution
9200100 In distribution
9200102 In distribution
9200095 In distribution
9009526 In distribution
9200071 In distribution
9200053 In distribution
9009514 In distribution
9200065 In distribution
9200103 In distribution
9200059 In distribution
9200083 In distribution
9200075 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Nobilium Cmp Industries, LLC 239
remanium® Dentaurum GmbH & Co. KG 56
Magnum Splendidum Mesa DI Sala Giacomo & C. SNC 47
Ceramill Sintron® Amann Girrbach AG 47
Magnum Solare Mesa DI Sala Giacomo & C. SNC 37
Base metal alloy Institut Straumann AG 34
Luminesse Ti-Cam Discs Talladium, Inc. 33
Starbond CoS S & S Scheftner GmbH 24
Dentorium Wright Medical Technology, Inc. 23
Starbond Easy S & S Scheftner GmbH 22
Magnum Hyperone Mesa DI Sala Giacomo & C. SNC 21
Starbond Ti4 S & S Scheftner GmbH 19

Showing 12 of 627. All products under Alloy, Metal, Base

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