NTI

NTI Big Pack(100) H21R-010FGSS

Registry build 21.09.26
46manufacturers in China registered for this device type
325catalogue 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 NTI
Listed by NTI-Kahla Gmbh, Rotary Dental Instruments, Germany
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-01-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for NTI
Catalogue number Size Per pack Status
H33L-012-HP 5 In distribution
H23-008-FG 5 In distribution
H33L-009-FG 100 In distribution
HF251XCE-060 In distribution
H1S-016-RA 5 In distribution
249-016-FG In distribution
H1-018-FG 5 In distribution
H31R-012-HP 5 In distribution
H31-009-FG 100 In distribution
H23-010-FG 5 In distribution
H245-008-FGM 5 In distribution
H21R-010-FG 5 In distribution
H50-010-FG 5 In distribution
HF261QSCN-023 In distribution
H283-010-FG 5 In distribution
H33-009-FG 5 In distribution
HF077FE-023 In distribution
H2-010-RA 5 In distribution
H31-010-FG 100 In distribution
HF138GTI-023 In distribution
HF073FE-060 In distribution
H23L-012-FG 5 In distribution
H31-010-RA 5 In distribution
H247F-010-FG 5 In distribution
H7-008-FGM 5 In distribution
HF251CE-040 In distribution
HF079QF-040 In distribution
H1S-014-RA 5 In distribution
H1-014-RA 100 In distribution
H23-010-RA 5 In distribution
H1-018-RA 5 In distribution
H247-009-FG 5 In distribution
H33-009-HP 5 In distribution
H2-008-FG 5 In distribution
HF138CE-023 In distribution
H23-012-FG 5 In distribution
H8506-010-FG 5 In distribution
HF139SFE-023 In distribution
H21R-010-FGM 100 In distribution
HF078CE-060 In distribution
HF257CNR-060 In distribution
H31-010-FGM 100 In distribution
HF079SCE-060 In distribution
H48LF-012-FG 5 In distribution
HF261FE-023 In distribution
H7-010-FG 100 In distribution
H1-027-RA 5 In distribution
H36RS-012-FG 5 In distribution
H1-023-RA 100 In distribution
HF251CE-060 In distribution
H1-023-HP 5 In distribution
H33-012-HP 5 In distribution
HF138FE-023 In distribution
H283-014-FG 5 In distribution
H1-010-FG 100 In distribution
HFL251QSCN-060 In distribution
H1-018-FG 100 In distribution
H1S-010-RA 5 In distribution
H375R-018-FG 5 In distribution
H7-008-HP 5 In distribution
H283K-014-FG 5 In distribution
HF257FE-023 In distribution
H1S-010-FG 5 In distribution
H377-010-FG 5 In distribution
HF079CE-031 In distribution
HF351SCE-060 In distribution
H33-012-FG 100 In distribution
H282-012-FG 5 In distribution
HF351GE-060 In distribution
HF079CN-040 In distribution
H31-009-FG 5 In distribution
H336-016-FG 5 In distribution
HF138CE-016 In distribution
H23-009-FG 100 In distribution
H8503-014-FG 5 In distribution
H50A-010-FG 5 In distribution
H2-008-RA 5 In distribution
H282-010-FG 5 In distribution
HF139CE-023 In distribution
H7-012-FG 5 In distribution
H2-006-FG 100 In distribution
H375R-014-FG 5 In distribution
H48L-012-FG 5 In distribution
H2-010-HP 5 In distribution
H283-012-FG 5 In distribution
H1-006-FG 100 In distribution
HF078CE-023 In distribution
H7-010-FGM 5 In distribution
HF079CE-045 In distribution
HFL251CE-060 In distribution
H21R-010-FGM 5 In distribution
HF077CN-060 In distribution
HF079GTI-040 In distribution
H34-012-FG 5 In distribution
H284K-018-FG 5 In distribution
H31R-010-FGM 5 In distribution
H33-010-FG 5 In distribution
HF079SCE-045 In distribution
HF139FE-023 In distribution
H23-009-FG 5 In distribution
H7-008-FGM 100 In distribution
H2-014-FG 5 In distribution
H1-010-FG 5 In distribution
HFL251FE-060 In distribution
HF071CE-031 In distribution
H31R-012-FG 100 In distribution
H21R-008-FG 100 In distribution
H284-014-FG 5 In distribution
H375-012-FG 5 In distribution
H23L-010-FG 5 In distribution
H1-021-RA 5 In distribution
H1-012-FG 5 In distribution
HF071CN-027 In distribution
H1-005-FG 5 In distribution
HF138FE-016 In distribution
HF296CN-060 In distribution
HF071CE-050 In distribution
H23L-012-HP 5 In distribution
H7-006-FG 5 In distribution
HF129QSF-023 In distribution
H21-009-FG 100 In distribution
HF257SFE-060 In distribution
HF364CE-023 In distribution
H1S-023-RA 5 In distribution
HF138GTI-016 In distribution
HF129QF-023 In distribution
H31-014-HP 5 In distribution
H7-008-FG 5 In distribution
H41-010-FG 5 In distribution
H1-027-HP 5 In distribution
H21R-014-HP 5 In distribution
HF351FE-040 In distribution
H375-014-FG 5 In distribution
HF079SFE-040 In distribution
HF251GE-060 In distribution
H31R-012-FGM 5 In distribution
H1-023-RA 5 In distribution
H375R-016-FG 5 In distribution
H34-010-FG 5 In distribution
H247-012-FG 5 In distribution
H1-010-RA 5 In distribution
H248-009-FG 5 In distribution
H515S-023 In distribution
H1-008-RA 5 In distribution
HF261CE-023 In distribution
HF257CE-023 In distribution
H7-012-FG 100 In distribution
H1-005-FG 100 In distribution
H245-008-FGM 100 In distribution
H23-010-HP 5 In distribution
HF078FE-040 In distribution
H41-027-FG 5 In distribution
HF351FE-060 In distribution
H21-009-FG 5 In distribution
HF138SFE-023 In distribution
HF079CE-060 In distribution
H31-009-FGM 100 In distribution
H33-016-HP 5 In distribution
H2-014-RA 5 In distribution
H1-023-FG 5 In distribution
HF079QSF-040 In distribution
H375R-012-FG 5 In distribution
HF293CE-023 In distribution
H1-014-FG 100 In distribution
H8504-012-FG 5 In distribution
HF071CE-023 In distribution
H33-012-FG 5 In distribution
H41-023-FG 5 In distribution
HF390QSF-014 In distribution
250-016-FG In distribution
HF257CE-060 In distribution
H1-018-HP 5 In distribution
H1-006-HP 5 In distribution
H33-021-HP 5 In distribution
H1S-014-FG 5 In distribution
H1S-012-RA 5 In distribution
HF129GTI-023 In distribution
H33-010-HP 5 In distribution
HF257QF-023 In distribution
H2-008-FGM 5 In distribution
H2-010-FG 100 In distribution
H282K-016-FG 5 In distribution
H1-014-HP 5 In distribution
H50-018-FG 5 In distribution
H23-009-HP 5 In distribution
HF139QF-023 In distribution
H1-006-FGM 5 In distribution
H245-008-FG 100 In distribution
HF351XCE-070 In distribution
H23L-009-FG 100 In distribution
H1-014-RA 5 In distribution
H41-018-FG 5 In distribution
H247F-009-FG 5 In distribution
H31-009-FGM 5 In distribution
H2-008-HP 5 In distribution
H33-012-FGM 5 In distribution
HF073CE-014 In distribution
H31-010-FGM 5 In distribution
H21R-008-FG 5 In distribution
HF079SFE-045 In distribution
H33L-009-FG 5 In distribution
H31R-012-FG 5 In distribution
HF073CE-060 In distribution
HFL251QSF-060 In distribution
HF137CE-023 In distribution
H247F-007-FG 5 In distribution
HF138QSF-016 In distribution
H1-018-RA 100 In distribution
H21R-010-FG 100 In distribution
H1-012-RA 5 In distribution
HF079FE-045 In distribution
H1-005-RA 5 In distribution
H2-006-FG 5 In distribution
HF251FE-060 In distribution
HF251SCE-060 In distribution
H377-012-FG 5 In distribution
HF077QSCN-040 In distribution
H514S-023 In distribution
HF079CN-045 In distribution
HF077SFE-023 In distribution
H31R-010-HP 5 In distribution
H269GK-016-FGXL 3 In distribution
H1S-018-RA 5 In distribution
H247UF-009-FG 5 In distribution
H21-009-FGM 5 In distribution
H7-008-FG 100 In distribution
HF071CE-040 In distribution
H7-010-FGM 100 In distribution
HF073CN-060 In distribution
H21-010-FG 5 In distribution
HF079FE-060 In distribution
HF138QSF-023 In distribution
H247UF-007-FG 5 In distribution
HF364FE-023 In distribution
HF351CE-040 In distribution
HF129CE-023 In distribution
HF079FE-031 In distribution
HF295FE-023 In distribution
H33-016-FG 5 In distribution
HF295CE-023 In distribution
HF072CE-060 In distribution
HF351CN-060 In distribution
H245-008-FG 5 In distribution
H284K-016-FG 5 In distribution
H36RS-010-FG 5 In distribution
H1-018-FGM 5 In distribution
HF079CE-040 In distribution
H375-016-FG 5 In distribution
H336-018-FG 5 In distribution
H23L-009-FG 5 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
Bur, Dental Hager & Meisinger Gesellschaft mit beschränkter Haftung 1,458
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

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