Helmut Zepf

Root Elevator/Teaser, Heidbrink, FIG. 2, Double-Ended, 2,0MM, Without Serration AS PER Customer Drawing # 09-0196 REV B

Registry build 21.09.26
6manufacturers in China registered for this device type
233catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EMJ
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
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
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Helmut Zepf
Listed by Helmut Zepf Medizintechnik Gmbh, Germany
FDA product code EMJ
Device type Elevator, Surgical, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-12-16
Record revised 2023-12-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Helmut Zepf
Catalogue number Size Status
17.120.48WL In distribution
17.055.01 In distribution
17.415.02 In distribution
17.051.01 In distribution
17.384.02WL In distribution
17.100.46 In distribution
17.690.21 In distribution
17.007.70 In distribution
17.052.02 In distribution
17.301.00 In distribution
17.621.00 In distribution
17.008.08TI In distribution
17.008.08 In distribution
17.008.09 In distribution
17.020.01 In distribution
17.100.27WL In distribution
17.056.03 In distribution
17.054.01 In distribution
17.100.39WL In distribution
17.051.01K In distribution
17.395.02 In distribution
17.690.19 In distribution
17.648.00 In distribution
17.055.05WL In distribution
17.007.07LL In distribution
24.751.156 In distribution
17.100.57 In distribution
17.634.02 In distribution
17.604.00 In distribution
KS17.011 In distribution
17.007.03TI In distribution
17.100.15WL In distribution
17.418.01 In distribution
17.008.11 In distribution
KS17.010 In distribution
KS17.058 In distribution
17.051.03WL In distribution
KS17.191 In distribution
17.053.03 In distribution
KS17.034 In distribution
17.395.03 In distribution
17.368.01WL In distribution
17.006.02 In distribution
KS41.639 In distribution
17.008.03TI In distribution
17.054.03 In distribution
17.008.01TI In distribution
17.201.01 In distribution
17.050.03WL In distribution
17.014.02 In distribution
17.007.04 In distribution
KS17.301 In distribution
17.336.16 In distribution
17.008.05 In distribution
17.013.02 In distribution
17.051.08WL In distribution
17.056.01 In distribution
17.009.01 In distribution
17.677.17 In distribution
17.045.03HZU In distribution
24.751.155 In distribution
KS17.080 In distribution
17.101.62 In distribution
17.051.02K In distribution
17.051.02WL In distribution
17.200.03 In distribution
17.007.01 In distribution
17.006.01 In distribution
17.368.04WL In distribution
17.690.12A In distribution
17.690.16 In distribution
17.677.16 In distribution
17.009.05 In distribution
17.008.90 In distribution
17.634.01 In distribution
17.629.00 In distribution
17.604.02 In distribution
17.200.02 In distribution
17.681.00 In distribution
17.014.00 In distribution
17.690.17 In distribution
17.100.40WL In distribution
17.007.05 In distribution
41.877.23WL In distribution
17.050.06WL In distribution
17.401.02 In distribution
17.001.12 In distribution
17.301.05 In distribution
17.001.10 In distribution
17.339.16WL In distribution
17.336.15 In distribution
17.008.02TI In distribution
17.396.02 In distribution
KS17.048 In distribution
17.007.05TI In distribution
17.010.02 In distribution
38.471.15 In distribution
17.008.06TI In distribution
17.303.00 In distribution
17.401.01 In distribution
17.056.02 In distribution
17.302.00 In distribution
17.690.15 In distribution
17.418.00 In distribution
17.368.03WL In distribution
17.007.02 In distribution
17.368.02WL In distribution
KS17.190 In distribution
17.100.61 In distribution
17.052.03 In distribution
17.100.60 In distribution
17.690.13 In distribution
17.008.11TI In distribution
17.690.12 In distribution
17.007.02TI In distribution
17.410.03 In distribution
17.100.16WL In distribution
17.008.03 In distribution
17.055.02WL In distribution
17.050.01WL In distribution
17.100.10 In distribution
17.195.00 In distribution
KS17.012B In distribution
KS17.150 In distribution
17.008.10TI In distribution
17.008.09TI In distribution
KS17.304 In distribution
KS17.077 In distribution
17.051.07WL In distribution
17.100.35 In distribution
17.418.02 In distribution
17.014.01 In distribution
17.010.03 In distribution
17.008.05TI In distribution
17.380.01 In distribution
KS17.049 In distribution
17.001.01 In distribution
17.055.03WL In distribution
KS17.078RL In distribution
17.050.02WL In distribution
17.055.01WL In distribution
17.220.01 In distribution
17.201.02 In distribution
17.100.28WL In distribution
17.335.16 In distribution
17.001.13 In distribution
17.053.02 In distribution
17.100.39 In distribution
17.627.00 In distribution
17.301.10 In distribution
17.220.02 In distribution
17.100.03WL In distribution
17.191.00 In distribution
17.013.00 In distribution
17.396.01 In distribution
17.008.02 In distribution
17.190.00 In distribution
17.007.00TI In distribution
17.045.00 In distribution
17.423.02HZU In distribution
17.101.61 In distribution
17.001.03 In distribution
17.051.09WL In distribution
17.013.01 In distribution
KS17.074 In distribution
17.100.35WL In distribution
17.690.18 In distribution
17.220.00 In distribution
17.200.01 In distribution
17.220.69 In distribution
KS17.078RR In distribution
KS17.008 In distribution
17.690.11 In distribution
17.001.00 In distribution
17.396.03 In distribution
17.008.01LL In distribution
KS17.012 In distribution
17.100.08 In distribution
17.622.00 In distribution
17.100.34WL In distribution
17.045.04 In distribution
17.045.05 In distribution
17.335.15 In distribution
17.008.02LL In distribution
17.008.04TI In distribution
17.054.02 In distribution
26.183.00 In distribution
17.630.00 In distribution
KS17.073 In distribution
KS17.034S In distribution
KS17.900 In distribution
17.628.00 In distribution
KS17.057 In distribution
17.055.03 In distribution
17.051.03 In distribution
17.009.00 In distribution
17.423.01HZU In distribution
17.690.20 In distribution
17.008.04 In distribution
KS17.034C In distribution
17.051.01WL In distribution
38.473.15 In distribution
17.100.40 In distribution
KS17.151 In distribution
17.100.09 In distribution
17.055.02 In distribution
17.020.02 In distribution
17.634.00 In distribution
17.100.62 In distribution
17.101.60 In distribution
17.100.69WL In distribution
17.395.01 In distribution
17.001.11 In distribution
17.304.00 In distribution
17.100.11 In distribution
17.051.03K In distribution
17.050.04WL In distribution
17.337.15 In distribution
KS17.013 In distribution
17.384.01WL In distribution
17.045.04HZU In distribution
17.006.04 In distribution
17.052.01 In distribution
17.008.01 In distribution
17.337.16 In distribution
17.055.04WL In distribution
17.009.02 In distribution
17.051.02 In distribution
17.008.10 In distribution
17.339.15WL In distribution
17.008.90TI In distribution
17.690.14 In distribution
KS17.012C 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 465
Nordent Manufacturing Inc Nordent Manufacturing Inc 264
Power Dental USA Power Dental U.S.A. Inc. 247
Elevator KLS-Martin L.P. 231
Kohdent Kohler Medizintechnik GmbH 206
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 153
Stoma® Storz AM Mark Gmbh 150
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121
Elevator, Surgical, Dental Biomet Microfixation 120

Showing 12 of 743. All products under Elevator, Surgical, 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