Falcon

Distal End Small Cutter(SafetyHold)w/LongHandle

Registry build 21.09.26
64manufacturers in China registered for this device type
49catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZN
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Acot Plastics (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 8
medmix China Ltd Shanghai Shanghai Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
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

Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand

Record

Regulatory record for Falcon
Listed by Ortho Technology, Inc., United States
FDA product code DZN
Device type Instruments, Dental Hand
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2021-09-16
Record revised 2022-05-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2022-05-10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Falcon
Catalogue number Size Status
800-329 In distribution
800-320 In distribution
800-101 In distribution
800-325 In distribution
800-203 In distribution
800-331 In distribution
800-318 In distribution
800-220XL In distribution
800-202 In distribution
800-330 In distribution
800-332 In distribution
800-105 In distribution
800-306 In distribution
800-101XL In distribution
800-110 In distribution
800-328 In distribution
800-107 In distribution
800-334 In distribution
800-338 In distribution
800-337 In distribution
800-301 In distribution
800-304 In distribution
800-323 In distribution
800-206 In distribution
800-305 In distribution
800-103 In distribution
800-333 In distribution
800-219 In distribution
800-312 In distribution
800-213 In distribution
800-109 In distribution
800-309 In distribution
800-307 In distribution
800-319 In distribution
801-206B In distribution
800-221 In distribution
800-310 In distribution
800-335 In distribution
800-213B In distribution
800-207 In distribution
800-321 In distribution
800-336 In distribution
800-111 In distribution
800-302 In distribution
800-107XL In distribution
801-011 Withdrawn
801-207TT Withdrawn
801-206T Withdrawn
801-207T Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LMDental LM-Dental 936
A. Titan Instruments A. Titan Instruments, Inc. 544
Instruments, Dental Hand Hager & Meisinger Gesellschaft mit beschränkter Haftung 307
Power Dental USA Power Dental U.S.A. Inc. 209
Supremo Instrumentos Andre Gregate Braga Instrumentos Ltda 95
Henry Schein Henry Schein, Inc. 93
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 92
Diamodent Diamodent 81
Stoma® Storz AM Mark Gmbh 80
Nordent Manufacturing Inc Nordent Manufacturing Inc 77
Brasseler USA Peter Brasseler Holdings, LLC 67
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 58

Showing 12 of 1,362. All products under Instruments, Dental Hand

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