DD Prefab
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Prefab blanks…
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology. The Dental Direkt Prefab blanks are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a retaining element for fastening in the milling machine and a groove for aligning the direction of rotation (axis of rotation).
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.
| 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
| Listed by | Dental Direkt GmbH, Germany |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K191111 |
| Record published | 2023-07-03 |
| Record revised | 2025-12-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DFX 34 Set | Interface: 3.4mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| NNA 43/50 Set | Interface: 4.3mm and 5.0mm; Compatible with Nobel Biocare™ Nobel Active® system | In distribution |
| DFX 45 Set | Interface: 4.5mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| ZTA 35 Set | Interface: 3.5mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| ZBC 34 Set | Interface: 3.4mm; Compatible with Zimmer Biomet 3i Certain® system | In distribution |
| NNA 35 Set | Interface: 3.5mm; Compatible with Nobel Biocare™ Nobel Active® system | In distribution |
| SSY 48 Set | Interface: 4.8mm; Compatible with Straumann® Tissue Level system | In distribution |
| ZBC 41/50 Set | Interface: 4.1mm and 5.0mm; Compatible with Zimmer Biomet 3i Certain® system | In distribution |
| CCA 50 Set | Interface: 5.0mm; Compatible with Altatec Camlog® system | In distribution |
| DFX 38 Set | Interface: 3.8mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| DEV 54 Set | Interface: 5.4mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| NRE 35 Set | Interface: 3.5mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
| CCA 43 Set | Interface: 4.3mm; Compatible with Altatec Camlog® system | In distribution |
| DEV 42 Set | Interface: 4.2mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| DFX 55 Set | Interface: 5.5mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| CCA 33 Set | Interface: 3.3mm; Compatible with Altatec Camlog® system | In distribution |
| CCA 38 Set | Interface: 3.8mm; Compatible with Altatec Camlog® system | In distribution |
| DEV 36 Set | Interface: 3.6mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| AAS 45/50 Set | Interface: 4.5mm and 5.0mm; Compatible with DENTSPLY Implants® Astra Tech® system | In distribution |
| ZTA 57 Set | Interface: 5.7mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| ZTA 45 Set | Interface: 4.5mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| DEV 48 Set | Interface: 4.8mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| AAS 35/40 Set | Interface: 3.5mm and 4.0mm; Compatible with DENTSPLY Implants® Astra Tech® system | In distribution |
| NRE 50 Set | Interface: 5.0mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
| SBO 41/48 Set | Interface: 4.1mm and 4.8mm; Compatible with Straumann® Bone Level® system | In distribution |
| SSY 65 Set | Interface: 6.5mm; Compatible with Straumann® Tissue Level system | In distribution |
| SBO 33 Set | Interface: 3.3mm; Compatible with Straumann® Bone Level® system | In distribution |
| NRE 43 Set | Interface: 4.3mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K230218 | 2023-04-25 |
| K191111 | 2023-01-11 |
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.