MIS

Zirconia cemented incisor 15deg. abutment set coni. con., V3

Registry build 21.09.26
15manufacturers in China registered for this device type
880catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NHA
Manufacturer City Province Registered as Device types
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Exceldent Dental Technology Development Co., Ltd. Zhuhai Guangdong Contract manufacturer 12
DTS Digital Dental LAB Shenzhen Guangdong Contract manufacturer 11
KTJ Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shimmer Computerized Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 10
Zhuhai Crystal Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 9
NEW Perfect Dental LAB Shenzhen Guangdong Contract manufacturer 8
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Trausim Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
CBD Dental LAB, Inc Shenzhen Guangdong Manufacturer 11

Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous

Record

Regulatory record for MIS
Listed by MIS Implants Technologies Ltd., Israel
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Contract manufacturer, Manufacturer, Exporter
510(k) K040807
Record published 2022-11-16
Record revised 2024-05-15 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Distribution end date 2024-05-29

Catalogue Numbers

Catalogue numbers for MIS
Catalogue number Size Status
CK-NLC1 In distribution
CN-HS540 In distribution
ED-CPK84 In distribution
CS-H0443 In distribution
VS-MC101 In distribution
ED-GPC10 In distribution
MU-CC480 In distribution
CS-CPK43 In distribution
ED-A2510 In distribution
CS-TCI13 In distribution
CK-WPK82 In distribution
CS-CPK41 In distribution
CS-HA675 In distribution
CS-TB002 In distribution
CK-SPC4 In distribution
EK-WPK82 In distribution
CN-CPK41 In distribution
VS-P8355 In distribution
MW-TPA10 In distribution
MN-TPA12 In distribution
CK-WPK81 In distribution
MD-S0222 In distribution
VS-HS858 In distribution
VK-CPK62 In distribution
CM-SO301 In distribution
VK-NPK61 In distribution
CN-HS433 In distribution
CN-HA848 In distribution
MA-NC448 In distribution
CN-TCI23 In distribution
VK-NPK62 In distribution
MW-CPC62 In distribution
MW-TCH13 In distribution
CK-NPK42 In distribution
VK-NPK41 In distribution
CS-C4057 In distribution
CM-SO173 In distribution
CK-SLC4 In distribution
CS-CPK44 In distribution
CW-HS655 In distribution
CS-C4040 In distribution
EH-W3630 In distribution
MD-TCH23 In distribution
MA-WC548 In distribution
VS-TC013 In distribution
MK-CPK61 In distribution
MN-MAC10 In distribution
VS-TCI13 In distribution
MM-CEI46 In distribution
MK-NLC1 In distribution
CN-CPK64 In distribution
CW-MC103 In distribution
MW-AT152 In distribution
CK-CPK62-USA In distribution
VN-AT002 In distribution
CK-SPS55 In distribution
MK-WPK41 In distribution
CS-A1530 In distribution
MD-LOC04 In distribution
MM-G0330 In distribution
CA-PTC13 In distribution
MA-WO171 In distribution
CN-HA248 In distribution
CW-C2040 In distribution
CW-HA350 In distribution
EH-W4630 In distribution
MA-SC348 In distribution
CS-C3057 In distribution
CS-TC013 In distribution
MD-A2510 In distribution
MK-WPK61 In distribution
CN-HS833 In distribution
CS-HA575 In distribution
MM-H3040 In distribution
CS-C2040 In distribution
MK-CPC64 In distribution
MA-SO171 In distribution
CW-TC033 In distribution
MW-CC010 In distribution
CN-H0633 In distribution
CS-HS648 In distribution
CN-AN010 In distribution
CN-AN003 In distribution
VS-HS558 In distribution
MD-CPC63 In distribution
MA-WO172 In distribution
CN-TBF15 In distribution
MD-IN060 In distribution
CN-CPK61 In distribution
CK-WLC3 In distribution
CN-CPK44 In distribution
MK-NPK64 In distribution
CN-CIZ60 In distribution
CS-H0839 In distribution
CD-AN015 In distribution
VN-TB001 In distribution
CN-TCI33 In distribution
CW-AT153 In distribution
CM-SO302 In distribution
MK-CPK41 In distribution
MM-TCI57 In distribution
MA-SC248 In distribution
CD-SA400 In distribution
MK-CPK82 In distribution
EH-W5630 In distribution
CW-AT003 In distribution
VS-HS458 In distribution
VK-NPK43 In distribution
MN-TC023 In distribution
CW-C2057 In distribution
CN-MAC30 In distribution
CW-HA263 In distribution
CS-IN160 In distribution
CK-CPK81 In distribution
CN-HA548 In distribution
VN-P6240 In distribution
VN-P6340 In distribution
MA-NO172 In distribution
CS-B4375 In distribution
CW-AN151 In distribution
CK-NLC5 In distribution
CS-C3040 In distribution
MD-TBC15 In distribution
MN-TBC15 In distribution
MH-S0448 In distribution
CS-AN151 In distribution
CN-C3040 In distribution
MW-FTB15 In distribution
CN-HS440 In distribution
CW-HS450 In distribution
VK-CPK81 In distribution
MM-S0160 In distribution
MM-CF048 In distribution
MH-A4375 In distribution
CS-HS575 In distribution
MD-MAC10 In distribution
MM-H0540 In distribution
CS-CPK83 In distribution
CW-AT002 In distribution
CN-HA648 In distribution
EK-WPK61 In distribution
MK-WPC64 In distribution
CW-TB030 In distribution
MW-CP060 In distribution
CW-AT252 In distribution
CM-NO301 In distribution
CK-WLC5 In distribution
CA-GS001 In distribution
MK-WPK82 In distribution
VS-AT153 In distribution
CW-GP010 In distribution
CK-NLC4 In distribution
EK-WPK84 In distribution
MN-MC102 In distribution
MH-03375 In distribution
CK-NLC2 In distribution
CK-WPK61 In distribution
CN-GPC10 In distribution
CS-CPK64 In distribution
MN-LOC01 In distribution
CS-B3375 In distribution
LC3-00400 In distribution
ED-CPK81 In distribution
CN-HS333 In distribution
MM-T0450 In distribution
VS-AT002 In distribution
CN-AN001 In distribution
MH-54375 In distribution
CS-CPK62 In distribution
MD-TPA10 In distribution
MH-N2330 In distribution
MA-SO172 In distribution
CS-H0539 In distribution
MN-TPA10 In distribution
MK-NLC3 In distribution
MA-WC348 In distribution
CW-C4040 In distribution
CN-LOC05 In distribution
EH-02410 In distribution
MM-SA160 In distribution
MD-CPC62 In distribution
VN-P4440 In distribution
VN-P4240 In distribution
MM-CE046 In distribution
VS-TCI23 In distribution
CM-WO173 In distribution
MM-H3057 In distribution
CS-H0339 In distribution
VN-AT003 In distribution
MD-LOC05 In distribution
MM-H1557 In distribution
CS-LOC05 In distribution
MK-NPK43 In distribution
MD-CPK41 In distribution
MA-NO171 In distribution
MH-53330 In distribution
CK-SLC1 In distribution
CC1-00315 In distribution
CN-GP010 In distribution
MW-WMAC1 In distribution
CW-TC023 In distribution
EH-55410 In distribution
CW-C1540 In distribution
MM-H0557 In distribution
CN-AN320 In distribution
CS-HA475 In distribution
MN-LOC03 In distribution
CW-LOC05 In distribution
MU-BGC48 In distribution
MA-SO302 In distribution
CK-NPK63 In distribution
VN-TPA10 In distribution
CM-WO171 In distribution
MD-LOC03 In distribution
CM-WO302 In distribution
CW-HA550 In distribution
CS-A0010 In distribution
CN-MAC10 In distribution
CN-CPK62 In distribution
EC1-00410 In distribution
VK-CPK62-USA In distribution
MK-WPC63 In distribution
MH-55375 In distribution
CK-NPK41 In distribution
CS-MC103 In distribution
CM-SO303 In distribution
MK-NLC2 In distribution
CN-HA348 In distribution
VK-CPK63 In distribution
MA-NC348 In distribution
MH-N0442 In distribution
MH-W5630 In distribution
MH-A3375 In distribution
MD-CPC64 In distribution
VK-CPK64 In distribution
CW-AT251 In distribution
MH-N4330 In distribution
CN-H0833 In distribution
MW-FTB30 In distribution
MH-N3330 In distribution
CS-CPK61 In distribution
MD-CPK62 In distribution
EH-56410 In distribution
MD-P1530 In distribution
MN-LOC02 In distribution
CS-CPK82 In distribution
CW-TCI23 In distribution
CS-CPK81 In distribution
CS-TB015 In distribution
MK-SLC4 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MEDENTiKA Medentika GmbH 2,553
LW Vis Abutment Ossvis Co., Ltd. 2,520
Dess dental smart solutions Terrats Medical SL 1,715
Locator Zest Anchors, LLC 1,643
NobelProcera® Nobel Biocare AB 1,526
Azure Terrats Medical SL 1,360
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 1,308
LW Vis Abutment SET Ossvis Co., Ltd. 1,260
Abutment, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,240
Healing Abutment Megagen Implant Co., Ltd. 1,218
Chaorum Implant System Medimecca Co Ltd 1,084
OT Equator Rhein 83 SRL 1,051

Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K182228 2019-01-28
K173326 2018-03-16

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