Preat
O-Ring Mini Implant Master Servicing Kit. kit contains . 1 O-Ring Mini Implant Impression Coping . 1 O-Ring Mini Implant Analog . 1 O-Ring Closed Metal Housing MH-1 . 1 O-Ring Yellow…
O-Ring Mini Implant Master Servicing Kit. kit contains. 1 O-Ring Mini Implant Impression Coping. 1 O-Ring Mini Implant Analog. 1 O-Ring Closed Metal Housing MH-1. 1 O-Ring Yellow Processing #2 Micro Single. 2 O-Ring Black Rings #2 Micro Single. 1 O-Ring Purple Rings MH-2 Extra Strong Single
70manufacturers in China registered for this device type
181catalogue numbers in this listing
1recall
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.
| 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
| Listed by | Preat Corporation, United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-24 |
| Record revised | 2024-02-22 (version 8) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, inner pack, pack of 100, pack of 25, pack of 12, pack of 50 |
| Distribution end date | 2026-06-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0800200 | In distribution | ||
| 0800152 | In distribution | ||
| 0800264 | 6 | In distribution | |
| 2140CET | 4 | In distribution | |
| 30285NP | In distribution | ||
| 0800542 | In distribution | ||
| 0101251B | 6 | In distribution | |
| 0800267 | 6 | In distribution | |
| 7100022-4 | In distribution | ||
| 3TLP700 | In distribution | ||
| 9000055 | In distribution | ||
| 9004751 | In distribution | ||
| 0800163 | 6 | In distribution | |
| 7100020-4 | In distribution | ||
| 9000910 | In distribution | ||
| 7100019-10 | In distribution | ||
| 9003742 | In distribution | ||
| 0800149 | In distribution | ||
| 0101300P | In distribution | ||
| 9003701 | In distribution | ||
| 7100020-20 | In distribution | ||
| 9006751 | In distribution | ||
| 1500507 | In distribution | ||
| 1600036 | In distribution | ||
| 0800166 | 6 | In distribution | |
| 1600034 | In distribution | ||
| 7550073 | In distribution | ||
| 0800154 | In distribution | ||
| 0102006 | In distribution | ||
| 1776000 | In distribution | ||
| 1500650 | In distribution | ||
| 7550055 | In distribution | ||
| 9006851 | In distribution | ||
| 0101323 | In distribution | ||
| 0800161 | 6 | In distribution | |
| 2RT0H14 | 2 | In distribution | |
| 0800611 | In distribution | ||
| 9000100 | In distribution | ||
| 0800167 | 6 | In distribution | |
| 2RT00A1 | In distribution | ||
| 0800162 | 6 | In distribution | |
| 9003743 | In distribution | ||
| 1500195 | 6 | In distribution | |
| 0800148 | In distribution | ||
| 9006551 | In distribution | ||
| 30861TI | In distribution | ||
| 9003740 | In distribution | ||
| 1500503 | 12 | In distribution | |
| 1100005 | In distribution | ||
| 0800190 | In distribution | ||
| 0800268 | 6 | In distribution | |
| 0800261 | 6 | In distribution | |
| 30265TI | In distribution | ||
| 0200040 | In distribution | ||
| 20760CE | In distribution | ||
| 1600035 | In distribution | ||
| 1776030 | In distribution | ||
| 0804400 | 2 | In distribution | |
| 0800262 | 6 | In distribution | |
| 2RT00H5 | In distribution | ||
| 1500212 | In distribution | ||
| 1500605 | 12 | In distribution | |
| 0800155 | In distribution | ||
| 9000056 | In distribution | ||
| 1500197 | In distribution | ||
| 0800169 | 6 | In distribution | |
| 3X693AI | In distribution | ||
| 0109006 | In distribution | ||
| 0800164 | 6 | In distribution | |
| 9006451 | In distribution | ||
| 30800TI | In distribution | ||
| 30885TI | In distribution | ||
| 0101228 | In distribution | ||
| 2140CEN | 4 | In distribution | |
| 2140CER | 4 | In distribution | |
| 3X691DP | In distribution | ||
| 0101236 | In distribution | ||
| 9006651 | In distribution | ||
| 0800720 | 2 | In distribution | |
| 2140CEV | 4 | In distribution | |
| 1776010 | In distribution | ||
| 0800266 | 6 | In distribution | |
| 3TL0H13 | 2 | In distribution | |
| 20144AE | 2 | In distribution | |
| 0800269 | 6 | In distribution | |
| 9000046 | In distribution | ||
| 0200020 | In distribution | ||
| 9000054 | In distribution | ||
| 2RT0H12 | In distribution | ||
| 1500504 | 12 | In distribution | |
| 0800147 | In distribution | ||
| 2RT00P4 | In distribution | ||
| 30295IR | In distribution | ||
| 0800151 | In distribution | ||
| 1500610 | In distribution | ||
| 9001410 | In distribution | ||
| 7550074 | In distribution | ||
| 1500607 | In distribution | ||
| 0800196 | In distribution | ||
| 0101211 | In distribution | ||
| 0800250 | In distribution | ||
| 9007151 | In distribution | ||
| 0800197 | 2 | In distribution | |
| 1500603 | 12 | In distribution | |
| 9005751 | In distribution | ||
| 7100033-2 | In distribution | ||
| 0101232 | In distribution | ||
| 2RT0P25 | In distribution | ||
| 9000052 | In distribution | ||
| 30295TI | In distribution | ||
| 8003758 | In distribution | ||
| 9000048 | In distribution | ||
| 3X691EO | In distribution | ||
| 1100003 | In distribution | ||
| 30295NP | In distribution | ||
| 0101234 | In distribution | ||
| 0112300 | 2 | In distribution | |
| 9007051 | In distribution | ||
| 1500153 | In distribution | ||
| 7100022-20 | In distribution | ||
| 0102005 | In distribution | ||
| 9003708 | In distribution | ||
| 1500615 | In distribution | ||
| 9000053 | In distribution | ||
| 1500194 | 6 | In distribution | |
| 3X0694N | In distribution | ||
| 9003759 | In distribution | ||
| 3X691AP | In distribution | ||
| 0601251 | In distribution | ||
| 3694CL8 | In distribution | ||
| 0808610 | In distribution | ||
| 0807500 | In distribution | ||
| 0800153 | In distribution | ||
| 8000018 | In distribution | ||
| 0700006 | In distribution | ||
| 0101238 | In distribution | ||
| 9000061 | In distribution | ||
| 1100001 | In distribution | ||
| 8003705 | In distribution | ||
| 0101229 | In distribution | ||
| 0800194 | In distribution | ||
| 9000047 | In distribution | ||
| 9000810 | In distribution | ||
| 2RT00P7 | In distribution | ||
| 0800540 | In distribution | ||
| 1100004 | In distribution | ||
| 011222 | In distribution | ||
| 9000045 | In distribution | ||
| 9001300 | In distribution | ||
| 0101298 | In distribution | ||
| 1600037 | In distribution | ||
| 3TL00P4 | In distribution | ||
| 3696P00 | In distribution | ||
| 30200NP | In distribution | ||
| 1400620 | Withdrawn | ||
| 0102007 | 50 | Withdrawn | |
| 0102011 | 50 | Withdrawn | |
| 1400325 | Withdrawn | ||
| 8003702 | Withdrawn | ||
| 1921751 | Withdrawn | ||
| 1400320 | Withdrawn | ||
| 0101227B | Withdrawn | ||
| 3X0694D | Withdrawn | ||
| 1500610 | Withdrawn | ||
| 1300360 | Withdrawn | ||
| 1300365 | Withdrawn | ||
| 1300350 | Withdrawn | ||
| 0800168 | 6 | Withdrawn | |
| 1500157 | Withdrawn | ||
| 1400340 | Withdrawn | ||
| 0604066 | Withdrawn | ||
| 1500506-2 | 2 | Withdrawn | |
| 0102010 | 50 | Withdrawn | |
| 1400310 | Withdrawn | ||
| 0102008 | 50 | Withdrawn | |
| 0800143 | Withdrawn | ||
| 1500508 | 12 | Withdrawn | |
| 3TLH13 | 2 | Withdrawn | |
| 1500214 | Withdrawn | ||
| 1500608 | 12 | Withdrawn | |
| 3TL0H14 | 2 | Withdrawn |
Same 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 |
| MIS | MIS Implants Technologies Ltd. | 615 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-06-25 | Class II | Process control | Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations. | 185 devices |
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.