Applicator Tips

Automix tips + intra-oral tips for Spee-Dee Build-Up Cartridges – pkg. 20

Registry build 21.09.26
24manufacturers in China registered for this device type
38catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (5), Shanghai (4), Anhui (4). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KXR
Manufacturer City Province Registered as Device types
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
CAO (China) Medical Equipment Company, Limited Langfang Hebei Contract manufacturer 6
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50

Showing 12 of 24. All 24 manufacturers in China registered for Applicator, Resin

Record

Regulatory record for Applicator Tips
Listed by Pulpdent Corporation, United States
FDA product code KXR
Device type Applicator, Resin
Device class Class 1
Regulation 21 CFR 872.3140
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2021-09-21
Record revised 2023-02-03 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Applicator Tips
Catalogue number Size Per pack Status
22DR15 15 In distribution
A50 50 In distribution
22KK15 15 In distribution
AS20 20 In distribution
AD50T 50 In distribution
18G20 20 In distribution
25B50 50 In distribution
25B100 100 In distribution
30F50 50 In distribution
22KK75 75 In distribution
20L100 100 In distribution
22D20 20 In distribution
22K100 100 In distribution
22K20 20 In distribution
22DR75 75 In distribution
F20N2 20 In distribution
25B20 20 In distribution
20L20 20 In distribution
P25100 100 In distribution
30F100 100 In distribution
AD20T 20 In distribution
AD50R 50 In distribution
A20N1 20 In distribution
23R100 100 In distribution
P2520 20 In distribution
AS50 50 In distribution
22D100 100 In distribution
19K20 20 In distribution
A20 20 In distribution
FD20 20 In distribution
18G100 100 In distribution
T20G19 20 In distribution
AD20R 20 In distribution
FSB20 20 In distribution
A50N1 50 In distribution
19K100 100 In distribution
23R20 20 In distribution
PSYN 24 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Premium Plus Premium Plus (Dongguan) Limited 68
Microbrush Young Microbrush LLC 53
Safco Micro Applicators Safco Dental Supply 35
Benda Micro Centrix, Inc. 16
Como Tip B&L Biotech Co., Inc. 14
OptraSculpt Ivoclar Vivadent Aktiengesellschaft 14
Benda Brush Centrix, Inc. 11
Darby Dental Supply, LLC Darby Dental Supply, LLC 9
Defend Young Innovations Inc. 9
Advance Dental Products THE Atlanta Dental Supply Company 8
Accessory Bisco, Inc. 8
PlastCare Proguard Health Inc. 7

Showing 12 of 230. All products under Applicator, Resin

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