BruxZir®
BruxZir® is the listed name; the FDA filing identifies the subject device as BruxZir® NOW SRC. It describes a pre-manufactured prosthetic component that connects directly to an endosseous…
BruxZir® is the listed name; the FDA filing identifies the subject device as BruxZir® NOW SRC. It describes a pre-manufactured prosthetic component that connects directly to an endosseous implant for prosthetic rehabilitation.
The filing describes a two-piece abutment made of a pre -cemented titanium abutment and zirconia superstructure. Its customizations are designed and manufactured through a digital dentistry workflow.
Listed Item
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 3.7/4.2 mm, Bleach1
Device Function and Details
The filing describes the two-piece abutment as mounted on the implant and fixed with a screw. The workflow includes intra-oral scanner files, CAD and CAM software, a milling machine, and associated tooling and accessories.
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 | Prismatik Dentalcraft, Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K231940 |
| Record published | 2024-11-08 |
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 |
|---|---|---|
| 70-1185-NOW0101 | In distribution | |
| 70-1185-NOW0023 | In distribution | |
| 70-1185-NOW0108 | In distribution | |
| 70-1185-NOW0036 | In distribution | |
| 70-1185-NOW0022 | In distribution | |
| 70-1185-NOW0112 | In distribution | |
| 70-1185-NOW0064 | In distribution | |
| 70-1185-NOW0085 | In distribution | |
| 70-1185-NOW0094 | In distribution | |
| 70-1185-NOW0061 | In distribution | |
| 70-1185-NOW0026 | In distribution | |
| 70-1185-NOW0059 | In distribution | |
| 70-1185-NOW0131 | In distribution | |
| 70-1185-NOW0039 | In distribution | |
| 70-1185-NOW0082 | In distribution | |
| 70-1185-NOW0067 | In distribution | |
| 70-1185-NOW0070 | In distribution | |
| 70-1185-NOW0083 | In distribution | |
| 70-1185-NOW0055 | In distribution | |
| 70-1185-NOW0027 | In distribution | |
| 70-1185-NOW0056 | In distribution | |
| 70-1185-NOW0078 | In distribution | |
| 70-1185-NOW0075 | In distribution | |
| 70-1185-NOW0058 | In distribution | |
| 70-1185-NOW0045 | In distribution | |
| 70-1185-NOW0130 | In distribution | |
| 70-1185-NOW0087 | In distribution | |
| 70-1185-NOW0091 | In distribution | |
| 70-1185-NOW0054 | In distribution | |
| 70-1185-NOW0116 | In distribution | |
| 70-1185-NOW0034 | In distribution | |
| 70-1185-NOW0024 | In distribution | |
| 70-1185-NOW0042 | In distribution | |
| 70-1185-NOW0121 | In distribution | |
| 70-1185-NOW0025 | In distribution | |
| 70-1185-NOW0051 | In distribution | |
| 70-1185-NOW0088 | In distribution | |
| 70-1185-NOW0072 | In distribution | |
| 70-1185-NOW0111 | In distribution | |
| 70-1185-NOW0099 | In distribution | |
| 70-1185-NOW0096 | In distribution | |
| 70-1185-NOW0046 | In distribution | |
| 70-1185-NOW0052 | In distribution | |
| 70-1185-NOW0047 | In distribution | |
| 70-1185-NOW0128 | In distribution | |
| 70-1185-NOW0122 | In distribution | |
| 70-1185-NOW0089 | In distribution | |
| 70-1185-NOW0021 | In distribution | |
| 70-1185-NOW0084 | In distribution | |
| 70-1185-NOW0093 | In distribution | |
| 70-1185-NOW0118 | In distribution | |
| 70-1185-NOW0103 | 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 |
|---|---|
| K252582 | 2025-11-18 |
| K240240 | 2024-07-12 |
| K231940 | 2024-05-15 |
| K231097 | 2023-11-14 |
| K223496 | 2023-09-26 |
| K191222 | 2019-08-05 |
| K170044 | 2017-06-06 |
| K160979 | 2016-11-04 |
| K151798 | 2015-11-16 |
| K151375 | 2015-10-07 |
| K143515 | 2015-10-01 |
| K141923 | 2015-01-06 |
| K142118 | 2014-11-25 |
| K142115 | 2014-11-13 |
| K141211 | 2014-10-22 |
| K121391 | 2012-12-10 |
| K120858 | 2012-12-06 |
| K121688 | 2012-10-12 |
| K100993 | 2010-12-28 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2025-09-30 | Class II | Employee error | Incorrect titanium screw, packaged with dental implant. | 208 units |
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.