DIO SM-Extra Wide(RBM) Implant Systems
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in…
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
15manufacturers in China registered for this device type
157catalogue numbers in this listing
5510(k) clearances naming this product code
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 | DIO Corporation, South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-01-21 |
| Record revised | 2022-02-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2022-02-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAC 7865T(II) | Ø7.8X5.5(6.0)mm | Withdrawn |
| SAS 6825(II) | Ø6.8X5.5(2.0)mm | Withdrawn |
| SAS 5844(II) | Ø5.8X4.0(4.5)mm | Withdrawn |
| SASP 5810S | Ø5.8X10.0mm | Withdrawn |
| SIT 5203T | Ø5.2X10.85mm TORX | Withdrawn |
| SAS 6847(II) | Ø6.8X7.0(4.5)mm | Withdrawn |
| SAC 4834N(II) | Ø4.8X4.0(3.0)mm | Withdrawn |
| SAS 5834(II) | Ø5.8X4.0(3.0)mm | Withdrawn |
| SAC 5824T(II) | Ø5.8X4.0(2.0)mm | Withdrawn |
| SAS 5824(II) | Ø5.8X4.0(2.0)mm | Withdrawn |
| SAC 6825T(II) | Ø6.8X5.5(2.0)mm | Withdrawn |
| SAC 4825T(II) | Ø4.8X5.5(2.0)mm | Withdrawn |
| SAS 6814(II) | Ø6.8X4.0(1.0)mm | Withdrawn |
| SAC 4825N(II) | Ø4.8X5.5(2.0)mm | Withdrawn |
| SAC 4824N(II) | Ø4.8X4.0(2.0)mm | Withdrawn |
| SAH 6235 | Ø6.2X5.0(3.0)mm | Withdrawn |
| SAC 7835T(II) | Ø7.8X5.5(3.0)mm | Withdrawn |
| SAC 5834T(II) | Ø5.8X4.0(3.0)mm | Withdrawn |
| SAC 6814N(II) | Ø6.8X4.0(1.0)mm | Withdrawn |
| SAH 6224 | Ø6.2X4.0(2.0)mm | Withdrawn |
| SAS 4864(II) | Ø4.8X4.0(6.0)mm | Withdrawn |
| SAC 7844N(II) | Ø7.8X4.0(4.5)mm | Withdrawn |
| SAS 6817(II) | Ø6.8X7.0(1.0)mm | Withdrawn |
| SAC 7825T(II) | Ø7.8X5.5(2.0)mm | Withdrawn |
| SAC 6814T(II) | Ø6.8X4.0(1.0)mm | Withdrawn |
| SAC 7864T(II) | Ø7.8X4.0(6.0)mm | Withdrawn |
| SAC 4845N(II) | Ø4.8X5.5(4.5)mm | Withdrawn |
| SAC 6815N(II) | Ø6.8X5.5(1.0)mm | Withdrawn |
| SIT 5202T | Ø5.2X9.85mm TORX | Withdrawn |
| SAC 5814N(II) | Ø5.8X4.0(1.0)mm | Withdrawn |
| SAC 4814T(II) | Ø4.8X4.0(1.0)mm | Withdrawn |
| SAH 6238 | Ø6.2X8.0(3.0)mm | Withdrawn |
| SAS 4865(II) | Ø4.8X5.5(6.0)mm | Withdrawn |
| SAC 5845T(II) | Ø5.8X5.5(4.5)mm | Withdrawn |
| SAC 5835N(II) | Ø5.8X5.5(3.0)mm | Withdrawn |
| SAC 7845T(II) | Ø7.8X5.5(4.5)mm | Withdrawn |
| SAS 5825(II) | Ø5.8X5.5(2.0)mm | Withdrawn |
| SAH 5238 | Ø5.2X8.0(3.0)mm | Withdrawn |
| SAH 5235 | Ø5.2X5.0(3.0)mm | Withdrawn |
| SAS 4844(II) | Ø4.8X4.0(4.5)mm | Withdrawn |
| SAS 4834(II) | Ø4.8X4.0(3.0)mm | Withdrawn |
| SAC 6864T(II) | Ø6.8X4.0(4.5)mm | Withdrawn |
| SAC 6864N(II) | Ø6.8X4.0(6.0)mm | Withdrawn |
| SAC 6844T(II) | Ø6.8X4.0(4.5)mm | Withdrawn |
| SAC 4834T(II) | Ø4.8X4.0(3.0)mm | Withdrawn |
| SAS 4825(II) | Ø4.8X5.5(2.0)mm | Withdrawn |
| SAC 4814N(II) | Ø4.8X4.0(1.0)mm | Withdrawn |
| SAS 7867(II) | Ø7.8X7.0(6.0)mm | Withdrawn |
| SAC 7814T(II) | Ø7.8X4.0(1.0)mm | Withdrawn |
| SAC 7834N(II) | Ø7.8X4.0(3.0)mm | Withdrawn |
| SAS 5814(II) | Ø5.8X4.0(1.0)mm | Withdrawn |
| SAC 6824T(II) | Ø6.8X4.0(2.0)mm | Withdrawn |
| SAS 7817(II) | Ø7.8X7.0(1.0)mm | Withdrawn |
| SAS 7835(II) | Ø7.8X5.5(3.0)mm | Withdrawn |
| SAC 5834N(II) | Ø5.8X4.0(3.0)mm | Withdrawn |
| SAC 7824T(II) | Ø7.8X4.0(2.0)mm | Withdrawn |
| SAC 4865N(II) | Ø4.8X5.5(6.0)mm | Withdrawn |
| SAH 6213 | Ø6.2X3.0(1.0)mm | Withdrawn |
| SAC 7865N(II) | Ø7.8X5.5(6.0)mm | Withdrawn |
| SAS 5865(II) | Ø5.8X5.5(6.0)mm | Withdrawn |
| SSC 3520 | Ø3.5X2.0(Cuff)mm | Withdrawn |
| SAC 5845N(II) | Ø5.8X5.5(4.5)mm | Withdrawn |
| SAC 7845N(II) | Ø7.8X5.5(4.5)mm | Withdrawn |
| SAS 6835(II) | Ø6.8X5.5(3.0)mm | Withdrawn |
| SAC 6835N(II) | Ø6.8X5.5(3.0)mm | Withdrawn |
| SAC 7815N(II) | Ø7.8X5.5(1.0)mm | Withdrawn |
| SAC 6865N(II) | Ø6.8X5.5(6.0)mm | Withdrawn |
| SAS 6864(II) | Ø6.8X4.0(6.0)mm | Withdrawn |
| SAS 6865(II) | Ø6.8X5.5(6.0)mm | Withdrawn |
| SAS 6867(II) | Ø6.8X7.0(6.0)mm | Withdrawn |
| SAC 5844N(II) | Ø5.8X4.0(4.5)mm | Withdrawn |
| SAS 6815(II) | Ø6.8X5.5(1.0)mm | Withdrawn |
| SAC 5814T(II) | Ø5.8X4.0(1.0)mm | Withdrawn |
| SAH 5213 | Ø5.2X3.0(1.0)mm | Withdrawn |
| SAC 7835N(II) | Ø7.8X5.5(3.0)mm | Withdrawn |
| SAS 4837(II) | Ø4.8X7.0(3.0)mm | Withdrawn |
| SAH 5224 | Ø5.2X4.0(2.0)mm | Withdrawn |
| SAC 4844T(II) | Ø4.8X4.0(4.5)mm | Withdrawn |
| SAS 5864(II) | Ø5.8X4.0(6.0)mm | Withdrawn |
| SAC 7844T(II) | Ø7.8X4.0(4.5)mm | Withdrawn |
| SSC 3506 | Ø3.5X6.0mm | Withdrawn |
| SAS 6845(II) | Ø6.8X5.5(4.5)mm | Withdrawn |
| SAC 5844T(II) | Ø5.8X4.0(4.5)mm | Withdrawn |
| SAC 5825T(II) | Ø5.8X5.5(2.0)mm | Withdrawn |
| SAC 6834N(II) | Ø6.8X4.0(3.0)mm | Withdrawn |
| SAC 6865T(II) | Ø6.8X5.5(6.0)mm | Withdrawn |
| SAS 7865(II) | Ø7.8X5.5(6.0)mm | Withdrawn |
| SSC 3510 | Ø3.5X1.0(Cuff)mm | Withdrawn |
| SAC 6835T(II) | Ø6.8X5.5(3.0)mm | Withdrawn |
| SAS 4827(II) | Ø4.8X7.0(2.0)mm | Withdrawn |
| SAC 7834T(II) | Ø7.8X4.0(3.0)mm | Withdrawn |
| SAS 6837(II) | Ø6.8X7.0(3.0)mm | Withdrawn |
| SAC 5865N(II) | Ø5.8X5.5(6.0)mm | Withdrawn |
| SAC 7864N(II) | Ø7.8X4.0(6.0)mm | Withdrawn |
| SAC 6845N(II) | Ø6.8X5.5(4.5)mm | Withdrawn |
| SAS 7845(II) | Ø7.8X5.5(4.5)mm | Withdrawn |
| SAC 7815T(II) | Ø7.8X5.5(1.0)mm | Withdrawn |
| SAC 5825N(II) | Ø5.8X5.5(2.0)mm | Withdrawn |
| SAC 6825N(II) | Ø6.8X5.5(2.0)mm | Withdrawn |
| SAS 7844(II) | Ø7.8X4.0(4.5)mm | Withdrawn |
| SAS 7847(II) | Ø7.8X7.0(4.5)mm | Withdrawn |
| SAS 7825(II) | Ø7.8X5.5(2.0)mm | Withdrawn |
| SAC 5815T(II) | Ø5.8X5.5(1.0)mm | Withdrawn |
| SAC 5864T(II) | Ø5.8X4.0(6.0)mm | Withdrawn |
| SAS 6844(II) | Ø6.8X4.0(4.5)mm | Withdrawn |
| SASP 5810B | Ø5.8X10.0mm | Withdrawn |
| SAC 5815N(II) | Ø5.8X5.5(1.0)mm | Withdrawn |
| SAS 4867(II) | Ø4.8X7.0(6.0)mm | Withdrawn |
| SAC 6824N(II) | Ø6.8X4.0(2.0)mm | Withdrawn |
| SAS 5837(II) | Ø5.8X7.0(3.0)mm | Withdrawn |
| SAS 5845(II) | Ø5.8X5.5(4.5)mm | Withdrawn |
| SAS 7837(II) | Ø7.8X7.0(3.0)mm | Withdrawn |
| SAC 6815T(II) | Ø6.8X5.5(1.0)mm | Withdrawn |
| SAC 4844N(II) | Ø4.8X4.0(4.5)mm | Withdrawn |
| SAS 4835(II) | Ø4.8X5.5(3.0)mm | Withdrawn |
| SAC 4835N(II) | Ø4.8X5.5(3.0)mm | Withdrawn |
| SAC 5824N(II) | Ø5.8X4.0(2.0)mm | Withdrawn |
| SAC 7825N(II) | Ø7.8X5.5(2.0)mm | Withdrawn |
| SAC 4845T(II) | Ø4.8X5.5(4.5)mm | Withdrawn |
| SAH 6236 | Ø6.2X6.5(3.0)mm | Withdrawn |
| SAS 6834(II) | Ø6.8X4.0(3.0)mm | Withdrawn |
| SAC 7814N(II) | Ø7.8X4.0(1.0)mm | Withdrawn |
| SAS 4815(II) | Ø4.8X5.5(1.0)mm | Withdrawn |
| SAC 4824T(II) | Ø4.8X4.0(2.0)mm | Withdrawn |
| SAC 4865T(II) | Ø4.8X5.5(6.0)mm | Withdrawn |
| SAS 4817(II) | Ø4.8X7.0(1.0)mm | Withdrawn |
| SAS 5847(II) | Ø5.8X7.0(4.5)mm | Withdrawn |
| SAH 5236 | Ø5.2X6.5(3.0)mm | Withdrawn |
| SAS 7814(II) | Ø7.8X4.0(1.0)mm | Withdrawn |
| SAS 4814(II) | Ø4.8X4.0(1.0)mm | Withdrawn |
| SAC 5835T(II) | Ø5.8X5.5(3.0)mm | Withdrawn |
| SAS 4847(II) | Ø4.8X7.0(4.5)mm | Withdrawn |
| SAS 6824(II) | Ø6.8X4.0(2.0)mm | Withdrawn |
| SAS 5835(II) | Ø5.8X5.5(3.0)mm | Withdrawn |
| SAC 5865T(II) | Ø5.8X5.5(6.0)mm | Withdrawn |
| SAC 6834T(II) | Ø6.8X4.0(3.0)mm | Withdrawn |
| SAS 7824(II) | Ø7.8X4.0(2.0)mm | Withdrawn |
| SAC 6845T(II) | Ø6.8X5.5(4.5)mm | Withdrawn |
| SAS 4824(II) | Ø4.8X4.0(2.0)mm | Withdrawn |
| SAS 5817(II) | Ø5.8X7.0(1.0)mm | Withdrawn |
| SAS 5815(II) | Ø5.8X5.5(1.0)mm | Withdrawn |
| SAC 4835T(II) | Ø4.8X5.5(3.0)mm | Withdrawn |
| SAS 7815(II) | Ø7.8X5.5(1.0)mm | Withdrawn |
| SAS 7864(II) | Ø7.8X4.0(6.0)mm | Withdrawn |
| SAC 4815T(II) | Ø4.8X5.5(1.0)mm | Withdrawn |
| SAC 5864N(II) | Ø5.8X4.0(6.0)mm | Withdrawn |
| SAS 4845(II) | Ø4.8X5.5(4.5)mm | Withdrawn |
| SAC 4815N(II) | Ø4.8X5.5(1.0)mm | Withdrawn |
| SAC 4864T(II) | Ø4.8X4.0(6.0)mm | Withdrawn |
| SAS 6827(II) | Ø6.8X7.0(2.0)mm | Withdrawn |
| SAC 4864N(II) | Ø4.8X4.0(6.0)mm | Withdrawn |
| SAC 6844N(II) | Ø6.8X4.0(4.5)mm | Withdrawn |
| SAS 5867(II) | Ø5.8X7.0(6.0)mm | Withdrawn |
| SAS 5827(II) | Ø5.8X7.0(2.0)mm | Withdrawn |
| SAC 7824N(II) | Ø7.8X4.0(2.0)mm | Withdrawn |
| SAS 7827(II) | Ø7.8X7.0(2.0)mm | Withdrawn |
| SAS 7834(II) | Ø7.8X4.0(2.0)mm | Withdrawn |
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 |
|---|---|
| K220253 | 2023-08-18 |
| K193404 | 2020-05-18 |
| K192263 | 2020-02-21 |
| K190048 | 2019-09-30 |
| K181037 | 2018-12-21 |
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.