Tatum Surgical-Analog
Unipost UCLA 4.0mm Non-Hex Cylinder for Tatum Unipost Implants - S, T, & D Implants. Made of Delrin.
70manufacturers in China registered for this device type
41catalogue 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.
| 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 | Suncoast Dental, Inc., 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, Manufacturer |
| 510(k) | K811923 |
| Record published | 2020-02-27 |
| Record revised | 2020-12-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 3 to 8 mm; width 5 mm |
| Distribution end date | 2020-05-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Analog 4.0mm Xfer | Outer Diameter 4.0 mm | In distribution |
| Analog (CB) 4.0-4.5 | Outer Diameter 4.0 mm | In distribution |
| Analog ITI 8.0 | Outer Diameter 8.0 mm | In distribution |
| Analog (CB) 3.0 | Outer Diameter 3.0 mm | In distribution |
| Analog ITI UCLA 5.0 | Outer Diameter 5.0 mm | In distribution |
| Analog 8.0mm | Outer Diameter 8.0 mm | In distribution |
| Analog 5.0mm | Outer Diameter 5.0 mm | In distribution |
| Analog ITI UCLA 3.7-4.5 | Outer Diameter 3.7 mm | In distribution |
| Analog 4.0mm | Outer Diameter 4.0 mm | In distribution |
| Analog 7.0mm | Outer Diameter 7.0 mm | In distribution |
| Analog ITI UCLA 6.0-8.0 | Outer Diameter 6.0 mm | In distribution |
| Analog (CB) 5.0 | Outer Diameter 5.0 mm | In distribution |
| Analog Burn Out Large BPAL | In distribution | |
| Analog ITI OT 6.0-8.0 Xfer | Outer Diameter 6.0 mm | In distribution |
| Analog ITI 3.7-4.5 XFer | Outer Diameter 3.7 mm | In distribution |
| Analog Burn Out Small BPAS | In distribution | |
| Analog ITI 6.0-8.0 XFer | Outer Diameter 6.0 mm | In distribution |
| Analog ITI 7.0 | Outer Diameter 7.0 mm | In distribution |
| Analog (CB) 3.5 | Outer Diameter 3.5 mm | In distribution |
| Analog ITI 5.0 | Outer Diameter 5.0 mm | In distribution |
| Analog 4.0mm UCLA | Outer Diameter 4.0 mm | In distribution |
| Analog ITI 5.0 DIM | Width 5.0 mm | In distribution |
| Analog ITI 6.0 | Outer Diameter 6.0 mm | In distribution |
| Analog ITI OT 5.0 Xfer | Outer Diameter 5.0 mm | In distribution |
| Analog ITI 5.0 XFer | Outer Diameter 5.0 mm | In distribution |
| Analog ITI 4.0 | Outer Diameter 4.0 mm | In distribution |
| Analog 4.0 Shim | In distribution | |
| Analog 4.5mm | Outer Diameter 4.5 mm | In distribution |
| Analog ITI 3.7 | Outer Diameter 3.7 mm | In distribution |
| Analog ITI OT 3.7-4.5 Xfer | Outer Diameter 3.7 mm | In distribution |
| Analog (CB) 6.0 | Outer Diameter 6.0 mm | In distribution |
| Analog 3.5mm | Outer Diameter 3.5 mm | In distribution |
| Analog 6.0mm | Outer Diameter 6.0 mm | In distribution |
| Analog ITI 4.5 | Outer Diameter 4.5 mm | In distribution |
| Analog (SB) 5×14 | Outer Diameter 5.0 mm | Withdrawn |
| Analog (SB) 4.0×11 | Outer Diameter 4.0 mm | Withdrawn |
| Analog (SB) 4.0×17 | Outer Diameter 4.0 mm | Withdrawn |
| Analog (SB) 4.0×14 | Outer Diameter 4.0 mm | Withdrawn |
| Analog (SB) 5×17 | Outer Diameter 5.0 mm | Withdrawn |
| Analog (SB) 3.5×14 | Outer Diameter 3.5 mm | Withdrawn |
| Analog (SB) 4.5×14 | Outer Diameter 4.5 mm | 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
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.