A. Titan Instruments

Excavator, Double Ended, Hy-Lite Handle

Registry build 21.09.26
5manufacturers in China registered for this device type
43catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Hubei (1).

Chinese manufacturers registered for FDA product code EKC
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Hubei Lanbin Medical Group Co., Ltd. Xiaogan Hubei Contract manufacturer 33
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28

Record

Regulatory record for A. Titan Instruments
Listed by A. Titan Instruments, Inc., United States
FDA product code EKC
Device type Excavator, Dental, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-01-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for A. Titan Instruments
Catalogue number Size Status
Exc 31 L UL In distribution
EXC 21UL In distribution
Exc 31 In distribution
Exc 18 In distribution
EXC 1 UL In distribution
Exc 19 UL In distribution
EXC 35 In distribution
EXC 22 22 In distribution
EXC 19 22 In distribution
Exc 33 In distribution
Exc 31 UL In distribution
EXC 32 22 In distribution
EXC 23 22 In distribution
EXC 33 L 22 In distribution
Exc 17 UL In distribution
Exc 24 In distribution
EXC 33L (long) In distribution
Exc 16 In distribution
Exc 21 In distribution
Exc 24 22 In distribution
EXC 38-39 In distribution
EXC 18 22 In distribution
Exc 3 UL In distribution
EXC 31 22 In distribution
Exc 33 22 In distribution
Exc 32 UL In distribution
Exc 31 L 22 In distribution
Exc 20 In distribution
38-39 In distribution
Exc 31 L In distribution
Exc 17 In distribution
Exc 20 UL In distribution
Exc 3 In distribution
Exc 22 In distribution
EXC 17 22 In distribution
Exc 32 In distribution
Exc 21 22 In distribution
Exc 19 In distribution
Exc 23 In distribution
Exc 33L UL In distribution
Exc 20 22 In distribution
Exc 16 UL In distribution
Exc 18 UL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 193
Nordent Manufacturing Inc Nordent Manufacturing Inc 149
Integra® Miltex® Integra LifeSciences Production Corporation 59
Brasseler USA Peter Brasseler Holdings, LLC 44
Excavator Double Ended Maillefer Instruments Holding Sàrl 36
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 35
Power Dental USA Power Dental U.S.A. Inc. 34
Premier Excavators Premier Dental Products Co. 30
Zoll-Dental Zoll-Dental 28
Kohdent Kohler Medizintechnik GmbH 27
Darby Dental Supply, LLC Darby Dental Supply, LLC 27
Osung MND Osung MND Co., Ltd. 24

Showing 12 of 52. All products under Excavator, Dental, Operative

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