SimplyIconic™InterActive™ SMARTbase, Wide
2 catalogue numbers from 6534-82W, listed by Implant Direct Sybron Manufacturing LLC, 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
2catalogue numbers in this listing
6510(k) clearances naming this product code
6recalls 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 | Implant Direct Sybron Manufacturing LLC, United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K181359 |
| Record published | 2023-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6534-82W | Length: 2mm Platform: 3.4mm Width: 6.3mm | In distribution |
| 6534-82WT | “Platform 3.4mmD (RP) Conical Collar 2.0, Width 6.3, Post 6.6” | 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 |
|---|---|
| K223535 | 2023-06-20 |
| K192218 | 2020-05-08 |
| K191458 | 2019-10-10 |
| K181359 | 2018-08-15 |
| K162633 | 2017-07-24 |
| K153509 | 2016-08-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2023-05-02 | Class II | No Marketing Application | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. | 29 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2019-01-09 | Class II | Process control | Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, howe | 11 units | 2021-04-27 |
| 2018-01-23 | Class II | Process control | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. | 55 units | 2018-08-09 |
| 2018-01-19 | Class II | Process control | The extender that is packaged with the SwishTapered” and SwishPlus” Implant may have been packaged in the incorrect position (upside down in the plastic retainer). | 1,117 units total | 2023-07-26 |
| 2017-07-21 | Class II | Employee error | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. | 50 units | 2021-04-01 |
| 2015-10-28 | Class II | Unknown/Undetermined by firm | Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. | 478 | 2016-04-08 |
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.