Preat Implant Prosthetics
Blue Light ScanBuddy 1 (10-Pack) Kit includes: Zimmer TSV 3.5mm Blue Light Lab Scan Body Straumann® BL-compatible NC Blue Light Scan Body NobelActive™/Conical-compatible RP Blue Light Scan…
Blue Light ScanBuddy 1 (10-Pack) Kit includes: Zimmer TSV 3.5mm Blue Light Lab Scan Body Straumann® BL-compatible NC Blue Light Scan Body NobelActive™/Conical-compatible RP Blue Light Scan Body NobelActive™/Conical-compatible NP Blue Light Scan Body Hiossen® HG-compatible Standard Blue Light Scan Body MegaGen AnyRidge®-compatible Blue Light Scan Body Zimmer® TSV-compatible 4.5mm Blue Light Lab Scan Body NobelActive™/Conical-compatible WP Blue Light Scan Body Straumann® BL-compatible RC Blue Light Scan Body Multi-Unit Scan Body –.050
70manufacturers in China registered for this device type
130catalogue 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 | 2022-10-07 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 10, pack of 25, pack of 2 |
| Distribution end date | 2023-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9004403 | In distribution | ||
| 9005410 | In distribution | ||
| 9007103 | In distribution | ||
| 9006404 | In distribution | ||
| 9006804 | In distribution | ||
| 9005745 | In distribution | ||
| 9006803 | In distribution | ||
| 9005445 | In distribution | ||
| 9008545 | In distribution | ||
| 9005003 | In distribution | ||
| 9006701 | In distribution | ||
| 9002245 | In distribution | ||
| 9007545 | In distribution | ||
| 9000845 | In distribution | ||
| 9007245 | In distribution | ||
| 9005503 | In distribution | ||
| 9006403 | In distribution | ||
| 9005300 | In distribution | ||
| 8000060 | In distribution | ||
| 9000145 | In distribution | ||
| 9006503 | In distribution | ||
| 8000033 | In distribution | ||
| 9000703 | In distribution | ||
| 9000903 | In distribution | ||
| 1500505 | 12 | In distribution | |
| 9005145 | In distribution | ||
| 9004103 | In distribution | ||
| 9006452 | In distribution | ||
| 9005800 | In distribution | ||
| 9006652 | In distribution | ||
| 9001445 | In distribution | ||
| 9005845 | In distribution | ||
| 9002045 | In distribution | ||
| 9003703 | In distribution | ||
| 9005704 | In distribution | ||
| 9000545 | In distribution | ||
| 9005403 | In distribution | ||
| 1500506 | In distribution | ||
| 9004752 | In distribution | ||
| 9005703 | In distribution | ||
| 9007145 | In distribution | ||
| 9005245 | In distribution | ||
| 9005900 | In distribution | ||
| 9007204 | In distribution | ||
| 9000945 | In distribution | ||
| 9006845 | In distribution | ||
| 9006852 | In distribution | ||
| 9001503 | In distribution | ||
| 9004145 | In distribution | ||
| 9001403 | In distribution | ||
| 9005103 | In distribution | ||
| 9007052 | In distribution | ||
| 9001545 | In distribution | ||
| 8001741 | In distribution | ||
| 9006752 | In distribution | ||
| 9001645 | In distribution | ||
| 9001703 | In distribution | ||
| 9000445 | In distribution | ||
| 9004445 | In distribution | ||
| 9005200 | In distribution | ||
| 9001845 | In distribution | ||
| 9007004 | In distribution | ||
| 9006801 | In distribution | ||
| 9006545 | In distribution | ||
| 9005903 | In distribution | ||
| 9005045 | In distribution | ||
| 9007001 | In distribution | ||
| 9005545 | In distribution | ||
| 9000745 | In distribution | ||
| 1500204 | In distribution | ||
| 9006601 | In distribution | ||
| 9007200 | In distribution | ||
| 9002003 | In distribution | ||
| 9005203 | In distribution | ||
| 9002203 | In distribution | ||
| 9001345 | In distribution | ||
| 9006401 | In distribution | ||
| 9005904 | In distribution | ||
| 9007045 | In distribution | ||
| 9007101 | In distribution | ||
| 9005752 | In distribution | ||
| 9000603 | In distribution | ||
| 9000503 | In distribution | ||
| 9005804 | In distribution | ||
| 9005901 | In distribution | ||
| 9005701 | In distribution | ||
| 9003709 | In distribution | ||
| 9004701 | In distribution | ||
| 9001745 | In distribution | ||
| 9007203 | In distribution | ||
| 9004704 | In distribution | ||
| 9005645 | In distribution | ||
| 9004100 | In distribution | ||
| 9005345 | In distribution | ||
| 9006552 | In distribution | ||
| 9007104 | In distribution | ||
| 9006504 | In distribution | ||
| 9001245 | In distribution | ||
| 9001203 | In distribution | ||
| 9005801 | In distribution | ||
| 9004745 | In distribution | ||
| 9004703 | In distribution | ||
| 9006445 | In distribution | ||
| 9002145 | In distribution | ||
| 9007003 | In distribution | ||
| 9005700 | In distribution | ||
| 9006645 | In distribution | ||
| 9006604 | In distribution | ||
| 9007100 | In distribution | ||
| 9000345 | In distribution | ||
| 9001945 | In distribution | ||
| 9000245 | In distribution | ||
| 9007000 | In distribution | ||
| 9005945 | In distribution | ||
| 9007152 | In distribution | ||
| 9007201 | In distribution | ||
| 9006603 | In distribution | ||
| 9000645 | In distribution | ||
| 9006704 | In distribution | ||
| 9006501 | In distribution | ||
| 9005803 | In distribution | ||
| 9006745 | In distribution | ||
| 9006703 | In distribution | ||
| 9000803 | In distribution | ||
| 9002103 | In distribution | ||
| 9003741 | In distribution | ||
| 9005303 | In distribution | ||
| 8006640 | Withdrawn | ||
| 8003440 | Withdrawn | ||
| 8000090 | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Preat Corporation | UDI-DI | 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.