Universal Base
Universal Base Conical Connection NP 1.5mm
15manufacturers in China registered for this device type
6catalogue numbers in this listing
43510(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 | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-09-17 |
| Record revised | 2025-07-08 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Sizes | Height 1.5 to 3 mm |
| Distribution end date | 2025-07-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 38213 | Height 1.500 mm | Withdrawn |
| 38217 | Height 3.000 mm | Withdrawn |
| 38214 | Height 1.500 mm | Withdrawn |
| 38216 | Height 3.000 mm | Withdrawn |
| 38215 | Height 1.500 mm | Withdrawn |
| 38218 | Height 3.000 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 |
|---|---|
| K253999 | 2026-08-06 |
| K240346 | 2025-01-03 |
| K233208 | 2024-01-24 |
| K223677 | 2023-04-28 |
| K202452 | 2020-12-03 |
| K200040 | 2020-03-30 |
| K181869 | 2018-12-12 |
| K180899 | 2018-10-31 |
| K172854 | 2017-12-14 |
| K171466 | 2017-11-29 |
| K171142 | 2017-10-26 |
| K161416 | 2017-03-16 |
| K161655 | 2017-02-28 |
| K161435 | 2016-11-22 |
| K160158 | 2016-07-25 |
| K153036 | 2016-06-02 |
| K133377 | 2014-04-04 |
| K120954 | 2013-06-05 |
| K122602 | 2013-03-13 |
| K112259 | 2011-10-28 |
| K111581 | 2011-06-23 |
| K101714 | 2010-08-31 |
| K093643 | 2010-06-24 |
| K091848 | 2009-10-16 |
| K091907 | 2009-10-06 |
| K091904 | 2009-09-25 |
| K091756 | 2009-09-22 |
| K090069 | 2009-05-07 |
| K072129 | 2008-02-22 |
| K072570 | 2007-12-28 |
| K063592 | 2007-02-27 |
| K062749 | 2006-11-29 |
| K061529 | 2006-08-23 |
| K061478 | 2006-08-21 |
| K061477 | 2006-08-11 |
| K053050 | 2006-02-22 |
| K053068 | 2006-02-22 |
| K053125 | 2006-02-22 |
| K053602 | 2006-02-10 |
| K053091 | 2006-01-27 |
| K043042 | 2004-11-18 |
| K041236 | 2004-05-26 |
| K031719 | 2003-07-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nobel Biocare USA, LLC | UDI-DI | 2019-08-09 | Class II | Process control | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw | 238 pieces | 2021-12-01 |
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.