MARK3

Air Water Syringe Sleeves Clear 2-1/2" x 10" 500pcs/bx - 36bxs/cs - MARK3

Registry build 21.09.26
12manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (3), Hubei (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 PEM
Manufacturer City Province Registered as Device types
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Wellmed Dental Medical Supply Co., Ltd. Shenzhen Guangdong Manufacturer 37
Premium Plus (Dongguan) Limited Dongguan Guangdong Repacker / relabeller 34
Tianjin Water Source Tech Co., Ltd. Tianjin Tianjin Manufacturer 27
Fomed Industries Inc Qian Jiang Hubei Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Yueying Medical Instruments (Langfang) Co., Ltd. Langfang Hebei Contract manufacturer 9
Yongqing Huaguan Dental Instruments Factory Langfang Hebei Contract manufacturer 9

Record

Regulatory record for MARK3
Listed by Cargus International, Inc
FDA product code PEM
Device type Dental Barriers And Sleeves
Device class Class 2
Regulation 21 CFR 878.4370
Record published 2016-12-07
Record revised 2018-03-29 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for MARK3
Catalogue number Size Per pack Status
2104case 36 In distribution
2105case 6 In distribution
7799case 36 In distribution
1403 In distribution
7798case 36 In distribution
1402 In distribution
2101 In distribution
2127 In distribution
2125 In distribution
2103case 36 In distribution
2102 In distribution
2103 In distribution
1403case 12 In distribution
2104 In distribution
2124case 3 In distribution
2127case 60 In distribution
2125case 3 In distribution
2124 In distribution
7798 In distribution
2101case 20 In distribution
1402case 12 In distribution
2106 In distribution
2102case 20 In distribution
7799 In distribution
2105 In distribution
2106case 6 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Plasdent Plasdent Corp. 152
Premium Plus Premium Plus (Dongguan) Limited 61
Premium Plus Premium Plus International Limited 59
Pac-Dent PAC-Dent Inc. 44
JMU JMU Dental, Inc 42
Rinn® Dentsply LLC 25
iSmile Ismile Dental Products Inc. 19
ScanX Barrier Envelopes AIR Techniques, Inc. 13
Tidishield Tidi Products, LLC 12
Phosphor Plate Barrier Envelopes Maxill, Inc. 12
Benco Benco Dental Supply Co. 10
Patient Armor Barriers American Hospital Supply 10

Showing 12 of 154. All products under Dental Barriers And Sleeves

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