Bur, Dental

Rotary tungsten carbide instrument for dental application, sterile, single-use

Registry build 21.09.26
46manufacturers in China registered for this device type
1,458catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (12), Shanghai (8), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJL
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
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
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai MU Promotions Co., Ltd. Shanghai Shanghai Exporter 62
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51

Showing 12 of 46. All 46 manufacturers in China registered for Bur, Dental

Record

Regulatory record for Bur, Dental
Listed by Hager & Meisinger Gesellschaft mit beschränkter Haftung
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Premarket notification Exempt
Record published 2021-09-15
Record revised 2024-12-12 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bur, Dental
Catalogue number Size Per pack Status
HM1SQ 023 5 In distribution
CS556 FG 100 In distribution
C0002 RA 100 In distribution
C0006 RA 100 In distribution
HMM1000 010 5 In distribution
BTS02 In distribution
DD207 050 In distribution
236RF 031 In distribution
HMB141 031 2 In distribution
HM33R 012 5 In distribution
11RF 014 10 In distribution
HM33R 016 5 In distribution
B2001 In distribution
HM375R 016 5 In distribution
1RF 005 10 In distribution
5023017 In distribution
HM31 010 In distribution
5023018 In distribution
C0002S RAL 100 In distribution
HM1 014 5 In distribution
HMB166 021 2 In distribution
41 031 10 In distribution
MOHM1SQ-016-RA 25 In distribution
1 008 10 In distribution
HMCN167 023 2 In distribution
HM7 008 In distribution
C0169 FG 100 In distribution
HM379 014 5 In distribution
236RF 040 In distribution
HM31S 008 5 In distribution
HM33 016 5 In distribution
5024022 In distribution
1RF 010 10 In distribution
ATS02 In distribution
HM1 014 In distribution
HM1S 014 5 In distribution
236RF 007 In distribution
HM7L 008 5 In distribution
HM161RX 018 2 In distribution
HM1SQ 027 5 In distribution
236RF 023 In distribution
5038120 In distribution
E2004 In distribution
HMB1 023 5 In distribution
188RF 014 2 In distribution
38 018 10 In distribution
HM141F 040 2 In distribution
HM1 006 25 In distribution
HM41 016 5 In distribution
HM375LR 020 In distribution
HM1SQL 018 5 In distribution
HM191 012 In distribution
HM141AS 023 2 In distribution
HM23R 016 5 In distribution
890L 007 In distribution
5038151 In distribution
HM141 050 2 In distribution
C7902 FG 100 In distribution
HN015 040 In distribution
HMB31 012 5 In distribution
HM191A 010 2 In distribution
C031C FG 100 In distribution
MOHM1-016-RA 25 In distribution
HM2 010 5 In distribution
HM31 008 5 In distribution
HMB1 018 5 In distribution
HM1 009 5 In distribution
236RF 050 In distribution
2571 In distribution
38 008 10 In distribution
194 010 10 In distribution
HMB166 021 2 In distribution
HM236 050 In distribution
163 014 2 In distribution
HM48L 010 5 In distribution
203RF 018 In distribution
F3004 In distribution
TC084 004 2 In distribution
HM33L 010 5 In distribution
HM33T 016 2 In distribution
180GR 130 10 In distribution
C21RX FG 100 In distribution
202RF 008 5 In distribution
HN011 020 In distribution
HM31 009 5 In distribution
203RF 006 2 In distribution
C0330FGO 100 In distribution
HM151 016 2 In distribution
HM296GX 040 2 In distribution
HM1 010 25 In distribution
141RF 050 In distribution
HM141F 018 2 In distribution
C7404 FG 100 In distribution
HM7 008 In distribution
GS01 In distribution
C557L FG 100 In distribution
141RF 027 2 In distribution
HM2 008 5 In distribution
M303 000 10 In distribution
6736-463 10 In distribution
HM31 014 5 In distribution
D2003 In distribution
C0170 FG 100 In distribution
HM31 010 5 In distribution
C0702 SU 100 In distribution
HM1SQ 010 5 In distribution
BKA02 In distribution
HM1 009 5 In distribution
75 060 5 In distribution
5024017 In distribution
HM141F 040 2 In distribution
D1003 In distribution
HM1SQ 021 5 In distribution
HM D133U 010 5 In distribution
HMCN163 016 2 In distribution
HMG21RX 010 5 In distribution
HMM556 009 5 In distribution
161RF 016 2 In distribution
RF242 014 In distribution
HM21 010 5 In distribution
GD1 023 In distribution
HM33R 016 5 In distribution
HM1 008 5 In distribution
HM162A 016 2 In distribution
136RF 100 In distribution
C0002S FG 100 In distribution
128RF 070 2 In distribution
C1003 In distribution
HM D135F 014 5 In distribution
HM1SQ 016 5 In distribution
HM1 005 5 In distribution
HM33 016 5 In distribution
I2003 In distribution
A1004 In distribution
191R 120 10 In distribution
HM31 012 5 In distribution
HM163 014 2 In distribution
1 018 10 In distribution
HM141F 018 2 In distribution
HM141 023 2 In distribution
C0014 RA 100 In distribution
TDS08 035 In distribution
141RF 031 2 In distribution
HM1 014 5 In distribution
159RF 023 2 In distribution
C0003 RA 100 In distribution
TDS08 042 In distribution
UN245 009 25 In distribution
HM1S 018 5 In distribution
HM191 008 In distribution
182 180 10 In distribution
IRC02 In distribution
239RF 023 In distribution
162RF 016 2 In distribution
C0245 FG 100 In distribution
HM1S 021 5 In distribution
HM132U 008 5 In distribution
HM44E 023 5 In distribution
LSD10 In distribution
HM1 007 5 In distribution
HM141F 050 2 In distribution
HM1SQ 023 5 In distribution
84RF 050 5 In distribution
C0006S RAL 100 In distribution
HM236G 027 In distribution
HM1 027 5 In distribution
HM77GX 060 2 In distribution
C0004S FG 100 In distribution
HM33 012 5 In distribution
81RF 060 5 In distribution
HM141A 035 2 In distribution
GD1 023 In distribution
MOHM1S-016-RA 25 In distribution
HM31S 023 5 In distribution
85RF 060 In distribution
HMRX5 012 5 In distribution
HM23FX 023 2 In distribution
HM33 021 5 In distribution
41 012 10 In distribution
HM33 023 5 In distribution
183PR 120 10 In distribution
IT01 In distribution
C0701L FG 100 In distribution
168 023 In distribution
1 016 10 In distribution
HM166 021 2 In distribution
F191R 120 In distribution
HMB2 008 5 In distribution
166RF 021 2 In distribution
HM31R 009 5 In distribution
C331L FG 100 In distribution
PGSSB 007 2 In distribution
G1003 In distribution
TDS0T 035 In distribution
HM48L 014 5 In distribution
C0700 FG 100 In distribution
LC00S 026 In distribution
F1004 In distribution
HM D134F 014 5 In distribution
HM23L 009 5 In distribution
HM31 008 5 In distribution
HM1 023 25 In distribution
36 008 10 In distribution
C0558 FG 100 In distribution
HM31 010 25 In distribution
203RF 005 2 In distribution
HM133 010 5 In distribution
LC00S 036 In distribution
HM244K 016 5 In distribution
HMB1S 018 5 In distribution
HM166RX 021 2 In distribution
LSD12 In distribution
TC084 005 2 In distribution
1RF 023 10 In distribution
MU165 023 In distribution
95RF 060 5 In distribution
HM36R 012 5 In distribution
C0008 SU 100 In distribution
HM33L 012 5 In distribution
5024010 In distribution
HM48LU 023 5 In distribution
1RF 018 10 In distribution
166 021 2 In distribution
39RF 010 10 In distribution
HM161RX 018 2 In distribution
5023019 In distribution
HM1SQL 023 5 In distribution
HMB141F 023 2 In distribution
HM41 012 5 In distribution
MOHM1-023-RA 25 In distribution
BE001 035 In distribution
HM23L 012 5 In distribution
HM17 012 5 In distribution
180GR 110 10 In distribution
HM79FX 040 2 In distribution
HM1 018 In distribution
F1003 In distribution
95RF 040 5 In distribution
HM161 018 2 In distribution
MOHM1S-021-RA 25 In distribution
1RF 012 10 In distribution
HM25 012 5 In distribution
HM1SQ 010 5 In distribution
HM191A 014 2 In distribution
CB0557 FG 100 In distribution
HM379F 018 5 In distribution
LSD06 In distribution
TC084 008 2 In distribution
1 009 10 In distribution
HM141A 035 2 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MDT Tungsten Carbide Dental Burs M.D.T. – Micro Diamond Technologies Ltd. 1,795
Brasseler USA Peter Brasseler Holdings, LLC 1,719
Edenta Edenta Etablissement 1,415
Alpen Coltene/Whaledent Gmbh & Co. KG 1,243
Komet Dental Tungsten Carbide Burs Gebr. Brasseler Gmbh & Co. KG 760
Henry Schein Henry Schein, Inc. 665
House Brand Dentistry Frontier Dental Supply Inc 659
SSW Carbide SS White Burs LLC 610
Sabur By 3D Dental 3D Dental Designs AND Development, LLC 530
Beyes Beyes Dental Canada, Inc. 509
Johnson-Promident Young Innovations Inc. 439
Darby Dental Supply, LLC Darby Dental Supply, LLC 423

Showing 12 of 2,159. All products under Bur, Dental

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