MIS

MGUIDE drills replacement kit for standard sleeve procedures

Registry build 21.09.26
70manufacturers in China registered for this device type
615catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NDP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
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

Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous

Record

Regulatory record for MIS
Listed by MIS Implants Technologies Ltd., Israel
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Contract manufacturer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-11-16
Record revised 2024-05-15 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation High-level Disinfectant
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2024-05-15
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for MIS
Catalogue number Size Status
MT-ESM10 In distribution
MG-D1124 In distribution
MW-MAN10 In distribution
MW-MAB10 In distribution
CN-RSM10 In distribution
CS-IO485 In distribution
MT-LRH20 In distribution
MT-S3510 In distribution
MT-S3508 In distribution
MD-IT100 In distribution
MT-TDI40 In distribution
MN-PF330 In distribution
MG-NTAS1 In distribution
MK-CD01 In distribution
MK-0039 In distribution
MT-TP500 In distribution
MG-N1637 In distribution
CG-NRS10 In distribution
MT-HMR20 In distribution
CN-IO405 In distribution
MT-BTT55 In distribution
MT-00600 In distribution
MT-SRA10 In distribution
MT-BT050 In distribution
VN-IO331 In distribution
CT-BTC30 In distribution
MT-TDN28 In distribution
CT-WSI10 In distribution
CW-IO555 In distribution
MT-RDS30 In distribution
MG-D0837 In distribution
CW-IO505 In distribution
MG-N0624 In distribution
MG-N1033 In distribution
MT-BT032 In distribution
MT-CS410 In distribution
MT-SMD10 In distribution
MT-GDN50 In distribution
MT-BT028 In distribution
MD-RSM10 In distribution
CT-NLR30 In distribution
CG-GRW10 In distribution
MG-NRN01 In distribution
MD-PF375 In distribution
CN-MAB10 In distribution
MW-SP102 In distribution
MT-BTT40 In distribution
LT-WLR10 In distribution
MG-N0824 In distribution
MT-ETD38 In distribution
MT-TDN40 In distribution
MG-D1042 In distribution
MG-N1624 In distribution
MT-RB225 In distribution
MB-DB235 In distribution
CG-GRN01 In distribution
MK-CDS08 In distribution
MT-CD410 In distribution
MK-0057 In distribution
MT-TDI50 In distribution
MG1-TE480 In distribution
MT-BTT32 In distribution
MN-IT340 In distribution
MG-N1633 In distribution
VN-RSM10 In distribution
MG-D0824 In distribution
MG-NTAS0 In distribution
MT-CS420 In distribution
CT-SSM30 In distribution
LT-SSR10 In distribution
MG-NSI40 In distribution
MT-MLM30 In distribution
CT-NSR10 In distribution
MB-PR010 In distribution
VN-IC401 In distribution
CT-TDC30 In distribution
CT-NLR10 In distribution
CW-RSM10 In distribution
MD-RSM80 In distribution
MG-TAS55 In distribution
MW-RSM80 In distribution
MT-LBT32 In distribution
MT-SRH20 In distribution
MT-SRH21 In distribution
CG-NTAS0 In distribution
MT-TDT55 In distribution
CW-IT340 In distribution
MT-LRH21 In distribution
CS-IC485 In distribution
MG-D0024 In distribution
MW-ITC30 In distribution
MT-MFXGS In distribution
MT-RE172 In distribution
MG-P1024 In distribution
MT-S3511 In distribution
CG-D1150 In distribution
CG-N1333 In distribution
MD-I0375 In distribution
CT-WLR10 In distribution
MT-SHA10 In distribution
MM-SP104 In distribution
CG-D1143 In distribution
MK-SDS11 In distribution
MG-DFP20 In distribution
MT-BTI20 In distribution
CT-SLR30 In distribution
CG-N1033 In distribution
CW-IT300 In distribution
MT-RDE30 In distribution
CT-SLR10 In distribution
MT-TF172 In distribution
MT-CLR21 In distribution
MT-RMR10 In distribution
MT-DE001 In distribution
MG-NMS10 In distribution
CG-D1639 In distribution
CG-GMN10 In distribution
MT-CSN33 In distribution
MN-ICH40 In distribution
CG-D0843 In distribution
MG-NS040 In distribution
MT-TDI45 In distribution
MN-IC600 In distribution
CG-TAS55 In distribution
MK-0045 In distribution
CT-P2410 In distribution
MW-IC040 In distribution
MG-NMN10 In distribution
MK-0020 In distribution
GI-WCH11 In distribution
CS-MAN10 In distribution
MT-CS500 In distribution
MT-RSM30 In distribution
MG-D0833 In distribution
MT-RT001 In distribution
MT-TDN55 In distribution
VN-SP102 In distribution
MG-D1342 In distribution
MG-D1050 In distribution
MT-LM005 In distribution
CS-RSM10 In distribution
MT-ETD28 In distribution
MT-RSD24 In distribution
MT-TDN45 In distribution
MK-BC101 In distribution
MT-MUL02 In distribution
VG-NRN10 In distribution
MT-S2411 In distribution
MT-MFXSS In distribution
MT-MURL2 In distribution
CG-TAS56 In distribution
MG-SD01 In distribution
CW-MAB10 In distribution
CN-IC405 In distribution
MK-SDS13 In distribution
CS-MAB10 In distribution
CG-NTAS1 In distribution
MD-RSM60 In distribution
MG-D0850 In distribution
MT-TDI30 In distribution
LT-WSR10 In distribution
MT-CLM21 In distribution
MT-RA480 In distribution
CN-IO335 In distribution
MT-ELM10 In distribution
MG-BM047 In distribution
MM-ICI57 In distribution
MT-TDO01 In distribution
MD-IT300 In distribution
MM-SP105 In distribution
MM-LOA40 In distribution
MG-IE160 In distribution
VG-NRS10 In distribution
MG-D1337 In distribution
CN-IO331 In distribution
MG-TP047 In distribution
MT-TDN32 In distribution
MW-IT100 In distribution
MT-CD365 In distribution
MG-TMP50 In distribution
MG-IE172 In distribution
MG-N0637 In distribution
MT-ETD32 In distribution
CG-D1043 In distribution
MT-TDT38 In distribution
MT-BTT28 In distribution
VG-GRN01 In distribution
MK-C101 In distribution
MT-PDM24 In distribution
MM-IOI11 In distribution
CG-N1133 In distribution
MG-D1637 In distribution
CT-P2406 In distribution
CG-D1650 In distribution
MT-TDI32 In distribution
MK-SDS10 In distribution
MT-LBT28 In distribution
MT-S3211 In distribution
MT-S3208 In distribution
MW-RSM60 In distribution
MG-N0837 In distribution
MG-D0624 In distribution
MM-ICI40 In distribution
CG-N1633 In distribution
MT-PP240 In distribution
MK-0064 In distribution
MT-RE160 In distribution
MG-BM055 In distribution
MG-P1324 In distribution
CT-BTC24 In distribution
MU-MAN10 In distribution
MG-P1124 In distribution
MT-CD310 In distribution
MW-IT300 In distribution
MT-CSM21 In distribution
MU-RSM48 In distribution
CG-D1633 In distribution
MT-MUR02 In distribution
MT-TDN50 In distribution
MB-SF200 In distribution
MT-BTT24 In distribution
CG-NMN10 In distribution
CG-GRN10 In distribution
MT-S4513 In distribution
CT-WSR10 In distribution
MD-ITC30 In distribution
MM-IO011 In distribution
OE-RSM60 In distribution
MG-D1037 In distribution
MT-ETD24 In distribution
MT-MSM30 In distribution
MT-BTT38 In distribution
VG-NRN01 In distribution
MT-NB225 In distribution
MN-IC040 In distribution
MT-RI040 In distribution
MG-D1033 In distribution
CT-NSM30 In distribution
MT-TDN38 In distribution
MD-IC800 In distribution
MT-TDT28 In distribution
VG-GRN10 In distribution
MT-CSR21 In distribution
MN-RSM40 In distribution
CT-TDC45 In distribution
MD-RSM48 In distribution
MG-D1150 In distribution
MG-KD06 In distribution
MT-RI030 In distribution
MD-ICH40 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accessories, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,379
Accessories, Implant, Dental, Endosseous Institut Straumann AG 1,320
Neobiotech Implant System Neobiotech Co., Ltd. 1,112
Inclusive Prismatik Dentalcraft, Inc. 1,045
Medentika Medentika GmbH 1,042
BioHorizons Biohorizons Implant Systems Inc. 1,008
IPD Implant Protesis Dental 2004 SL 998
Klockner Soadco, S.L. 995
Dynamic Abutment Solutions Talladium España, SL 877
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 738
Nobel Biocare® Nobel Biocare AB 703
Astra Tech Implant System® Dentsply Implants Manufacturing GmbH 596

Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous

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