DD Ti-Base 2CUT Nolock
The FDA identifies DD Ti-Base 2CUT noLock as one of the three parts in the DD Solid Connect CAD/CAM Abutment family. The Ti-Base is used as part of a two-piece abutment, with a…
The FDA identifies DD Ti-Base 2CUT noLock as one of the three parts in the DD Solid Connect CAD/CAM Abutment family.
The Ti-Base is used as part of a two-piece abutment, with a premanufactured base and a CAD/CAM zirconia upper structure.
Listed Item
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 Ti-Base 2CUT noLock serves as a titanium bonding base for individualized bridge and bar restorations. The titanium bonding bases are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a circumferential platform for designing the emergence profile and a shortenable cylinder for individualized patient care.
Component Construction and Role
The filing identifies the lower part of the DD Ti-Base 2CUT noLock as titanium Grade 5 alloy and the upper part as zirconia. The abutment family is used to support prosthetic restorations.
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 | 2023-07-04 |
| 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 |
|---|---|---|
| CCA 50 Set | Interface: 5.0mm; Compatible with Altatec Camlog® system | In distribution |
| DEV 48 Set | Interface: 4.8mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| ZBC 41/50 Set | Interface: 4.1mm and 5.0mm; Compatible with Zimmer Biomet 3i Certain® system | In distribution |
| NRE 50 Set | Interface: 5.0mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
| ZTA 45 Set | Interface: 4.5mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| CCA 43 Set | Interface: 4.3mm; Compatible with Altatec Camlog® system | In distribution |
| SSY 48 Set | Interface: 4.8mm; Compatible with Straumann® Tissue Level system | In distribution |
| ZBC 34 Set | Interface: 3.4mm; Compatible with Zimmer Biomet 3i Certain® system | In distribution |
| NRE 43 Set | Interface: 4.3mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
| AAS 45/50 Set | Interface: 4.5mm and 5.0mm; Compatible with DENTSPLY Implants® Astra Tech® system | In distribution |
| DFX 34 Set | Interface: 3.4mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| DEV 54 Set | Interface: 5.4mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| DFX 38 Set | Interface: 3.8mm; Compatible with DENTSPLY Implants® Frialit®/Xive® system | In distribution |
| SSY 65 Set | Interface: 6.5mm; Compatible with Straumann® Tissue Level system | In distribution |
| NNA 35 Set | Interface: 3.5mm; Compatible with Nobel Biocare™ Nobel Active® 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 |
| NRE 35 Set | Interface: 3.5mm; Compatible with Nobel Biocare™ Replace Select® system | In distribution |
| AAS 35/40 Set | Interface: 3.5mm and 4.0mm; Compatible with DENTSPLY Implants® Astra Tech® system | In distribution |
| ZTA 35 Set | Interface: 3.5mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| DEV 42 Set | Interface: 4.2mm; Compatible with DENTSPLY Implants® Astra EV system | In distribution |
| ZTA 57 Set | Interface: 5.7mm; Compatible with Zimmer Dental Tapered Screw-Vent® system | In distribution |
| DEV 36 Set | Interface: 3.6mm; Compatible with DENTSPLY Implants® Astra EV 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 |
| SBO 33 Set | Interface: 3.3mm; Compatible with Straumann® Bone Level® system | In distribution |
| SBO 41/48 Set | Interface: 4.1mm and 4.8mm; Compatible with Straumann® Bone Level® system | In distribution |
| DFX 55 Set | Interface: 5.5mm; Compatible with DENTSPLY Implants® Frialit®/Xive® 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.