Renova
35 catalogue numbers from 43109K, listed by Keystone Dental Inc., United States, under Abutment, Implant, Dental, Endosseous. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
35catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this 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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-05-30 |
| Record revised | 2021-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-04-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43109K | Withdrawn | |
| 43096K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 10038K | Outer Diameter 4.7 – 5.7mm | Withdrawn |
| 10035K | Outer Diameter 4.7 – 5.7mm | Withdrawn |
| 43104K | Withdrawn | |
| 43103K | Withdrawn | |
| 43111K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43089K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43106K | Withdrawn | |
| 43110K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 10032K | Outer Diameter 3.5 – 4.5mm | Withdrawn |
| 43107K | Withdrawn | |
| 43114K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43119K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 10037K | Outer Diameter 4.7 – 5.7mm | Withdrawn |
| 43102K | Withdrawn | |
| 43113K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43116K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43092K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 10040K | Outer Diameter 4.7 – 5.7mm | Withdrawn |
| 10033K | Outer Diameter 3.5 – 4.5mm | Withdrawn |
| 43105K | Withdrawn | |
| 43090K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43108K | Withdrawn | |
| 43120K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43010K | Outer Diameter 4.5 – 5.0mm | Withdrawn |
| 43007K | Outer Diameter 4.5 – 5.0mm | Withdrawn |
| 43121K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 10036K | Outer Diameter 4.7 – 5.7mm | Withdrawn |
| 43118K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43100K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43094K | Outer Diameter 4.5 – 5.5mm | Withdrawn |
| 43006K | Outer Diameter 4.5 – 5.0mm | Withdrawn |
| 43009K | Outer Diameter 4.5 – 5.0mm | Withdrawn |
| 10039K | Outer Diameter 4.7 – 5.7mm | 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 |
|---|---|
| K221381 | 2022-08-10 |
| K090397 | 2009-06-05 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-06-20 | Class II | Other | Abutments are unable to accept the final abutment screw | 20 units | 2018-04-09 |
| 2011-07-05 | Class II | Mixed-up of materials/components | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, | 35 units | 2013-03-11 |
| 2011-07-05 | Class II | Mixed-up of materials/components | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment | 22 units | 2013-03-11 |
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.