Aesculap

HEIDEMANN Dental Spatula, 7", (175 mm), double ended, elastic, especially flexible, ergonomic handle, peek handle, width: 2,500 mm,green, non-sterile, reusable

Registry build 21.09.26
64manufacturers in China registered for this device type
43catalogue 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 Aesculap
Listed by Aesculap AG, Germany
FDA product code DZN
Device type Instruments, Dental Hand
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-17
Record revised 2023-08-25 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number
Distribution end date 2025-02-04
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
DE158R In distribution
DX546 In distribution
DC322R In distribution
DE152R In distribution
DF028R In distribution
DO656R In distribution
DF163R In distribution
DO303R In distribution
DF080R In distribution
DF138R In distribution
DS015R In distribution
DF079R In distribution
DF029R In distribution
DF355R In distribution
DF161R In distribution
DF077R In distribution
DF056R In distribution
DF270R In distribution
DF153R In distribution
DA005C In distribution
DF078R In distribution
DF150R In distribution
DF165R In distribution
DF033R In distribution
DP726R In distribution
DC321R In distribution
DF086R In distribution
DX120R In distribution
DC064R In distribution
DF055R In distribution
DO302R In distribution
SL033R In distribution
DP725R In distribution
DF081R In distribution
DE151R Withdrawn
DF032R Withdrawn
DF090R Withdrawn
DE154R Withdrawn
DE150R Withdrawn
DE153R Withdrawn
DE156R Withdrawn
DE155R Withdrawn
DE157R 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