Brånemark System®
Brånemark System® Mk III Groovy RP 3.75x11.5mm
7manufacturers in China registered for this device type
157catalogue numbers in this listing
31510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2019-07-16 |
| Record revised | 2024-06-05 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Sizes | Length 7 to 52.5 mm; outer diameter 3.3 to 5 mm; angle 45 ° |
| Distribution end date | 2024-05-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28868 | Length 50.000 mm | In distribution |
| 28909 | Length 15.000 mm | In distribution |
| 32424 | In distribution | |
| 28929 | Length 13.000 mm | In distribution |
| 28913 | Outer Diameter 3.750 mm | In distribution |
| 28911 | Length 7.000 mm | In distribution |
| 28986 | In distribution | |
| 28925 | Outer Diameter 5.000 mm | In distribution |
| 28914 | Length 11.500 mm | In distribution |
| 28907 | Outer Diameter 3.300 mm | In distribution |
| 28865 | Length 42.500 mm | In distribution |
| 28986 | In distribution | |
| 28989 | In distribution | |
| 28906 | Outer Diameter 3.300 mm | In distribution |
| 28862 | Length 30.000 mm | In distribution |
| 28928 | Outer Diameter 5.000 mm | In distribution |
| 28920 | Outer Diameter 4.000 mm | In distribution |
| 28921 | Length 11.500 mm | In distribution |
| 28912 | Outer Diameter 3.750 mm | In distribution |
| 28926 | Outer Diameter 5.000 mm | In distribution |
| 28987 | In distribution | |
| 28916 | Length 15.000 mm | In distribution |
| 28988 | In distribution | |
| 28927 | Outer Diameter 5.000 mm | In distribution |
| 28863 | Length 35.000 mm | In distribution |
| 28867 | Length 47.500 mm | In distribution |
| 28915 | Outer Diameter 3.750 mm | In distribution |
| 28930 | Outer Diameter 5.000 mm | In distribution |
| 28917 | Outer Diameter 3.750 mm | In distribution |
| 28924 | Length 18.000 mm | In distribution |
| 28919 | Outer Diameter 4.000 mm | In distribution |
| 28864 | Angle 45.000 ° | In distribution |
| 28918 | Length 7.000 mm | In distribution |
| 28922 | Length 13.000 mm | In distribution |
| 28908 | Outer Diameter 3.300 mm | In distribution |
| 28869 | Angle 45.000 ° | In distribution |
| 32424 | In distribution | |
| 28987 | In distribution | |
| 28988 | In distribution | |
| 28923 | Length 15.000 mm | In distribution |
| 28866 | Length 45.000 mm | In distribution |
| 28897 | Withdrawn | |
| 32122 | Withdrawn | |
| 28915 | Outer Diameter 3.750 mm | Withdrawn |
| 28887 | Length 13.000 mm | Withdrawn |
| 32120 | Withdrawn | |
| 28928 | Outer Diameter 5.000 mm | Withdrawn |
| 28940 | Withdrawn | |
| 28885 | Length 10.000 mm | Withdrawn |
| 28916 | Length 15.000 mm | Withdrawn |
| 32126 | Withdrawn | |
| 32135 | Withdrawn | |
| 32129 | Withdrawn | |
| 28918 | Outer Diameter 4.000 mm | Withdrawn |
| 28884 | Withdrawn | |
| 34740 | Length 52.500 mm | Withdrawn |
| 28900 | Withdrawn | |
| 28899 | Withdrawn | |
| 30728 | Withdrawn | |
| 28938 | Withdrawn | |
| 34739 | Angle 45.000 ° | Withdrawn |
| 28887 | Length 13.000 mm | Withdrawn |
| 28879 | Withdrawn | |
| 34740 | Angle 45.000 ° | Withdrawn |
| 28923 | Length 15.000 mm | Withdrawn |
| 32118 | Withdrawn | |
| 32133 | Withdrawn | |
| 28927 | Outer Diameter 5.000 mm | Withdrawn |
| 32136 | Withdrawn | |
| 28911 | Outer Diameter 3.750 mm | Withdrawn |
| 28944 | Withdrawn | |
| 34724 | Angle 45.000 ° | Withdrawn |
| 28912 | Outer Diameter 3.750 mm | Withdrawn |
| 32130 | Withdrawn | |
| 28913 | Outer Diameter 3.750 mm | Withdrawn |
| 28894 | Withdrawn | |
| 32903 | Withdrawn | |
| 28867 | Length 47.500 mm | Withdrawn |
| 32907 | Withdrawn | |
| 28883 | Withdrawn | |
| 28889 | Withdrawn | |
| 28868 | Angle 45.000 ° | Withdrawn |
| 28930 | Outer Diameter 5.000 mm | Withdrawn |
| 28936 | Withdrawn | |
| 28929 | Length 13.000 mm | Withdrawn |
| 32137 | Withdrawn | |
| 28939 | Withdrawn | |
| 28902 | Withdrawn | |
| 28898 | Withdrawn | |
| 28888 | Outer Diameter 3.750 mm | Withdrawn |
| 32119 | Withdrawn | |
| 28922 | Length 13.000 mm | Withdrawn |
| 28907 | Length 11.500 mm | Withdrawn |
| 28908 | Outer Diameter 3.300 mm | Withdrawn |
| 32127 | Withdrawn | |
| 34738 | Angle 45.000 ° | Withdrawn |
| 32116 | Withdrawn | |
| 28862 | Withdrawn | |
| 32134 | Withdrawn | |
| 28942 | Withdrawn | |
| 28863 | Length 35.000 mm | Withdrawn |
| 28891 | Withdrawn | |
| 28919 | Outer Diameter 4.000 mm | Withdrawn |
| 28924 | Outer Diameter 4.000 mm | Withdrawn |
| 32132 | Withdrawn | |
| 28914 | Length 11.500 mm | Withdrawn |
| 28901 | Withdrawn | |
| 32131 | Withdrawn | |
| 28937 | Withdrawn | |
| 34738 | Length 47.500 mm | Withdrawn |
| 28933 | Withdrawn | |
| 28906 | Length 10.000 mm | Withdrawn |
| 34739 | Angle 45.000 ° | Withdrawn |
| 28893 | Withdrawn | |
| 28895 | Withdrawn | |
| 34723 | Length 30.000 mm | Withdrawn |
| 28890 | Withdrawn | |
| 28892 | Withdrawn | |
| 34737 | Length 45.000 mm | Withdrawn |
| 32128 | Withdrawn | |
| 32124 | Withdrawn | |
| 28934 | Withdrawn | |
| 28881 | Withdrawn | |
| 28943 | Withdrawn | |
| 28885 | Outer Diameter 3.750 mm | Withdrawn |
| 34736 | Length 42.500 mm | Withdrawn |
| 28921 | Outer Diameter 4.000 mm | Withdrawn |
| 28935 | Withdrawn | |
| 32138 | Withdrawn | |
| 28932 | Withdrawn | |
| 28941 | Withdrawn | |
| 34736 | Angle 45.000 ° | Withdrawn |
| 28866 | Angle 45.000 ° | Withdrawn |
| 28917 | Outer Diameter 3.750 mm | Withdrawn |
| 28869 | Angle 45.000 ° | Withdrawn |
| 28920 | Outer Diameter 4.000 mm | Withdrawn |
| 28926 | Length 8.500 mm | Withdrawn |
| 28886 | Withdrawn | |
| 32115 | Withdrawn | |
| 28925 | Length 7.000 mm | Withdrawn |
| 34735 | Length 40.000 mm | Withdrawn |
| 28880 | Withdrawn | |
| 34723 | Angle 45.000 ° | Withdrawn |
| 28878 | Withdrawn | |
| 28865 | Angle 45.000 ° | Withdrawn |
| 32121 | Withdrawn | |
| 28888 | Outer Diameter 3.750 mm | Withdrawn |
| 28896 | Withdrawn | |
| 34735 | Angle 45.000 ° | Withdrawn |
| 32114 | Withdrawn | |
| 28909 | Length 15.000 mm | Withdrawn |
| 28864 | Length 40.000 mm | Withdrawn |
| 32117 | Withdrawn | |
| 34724 | Angle 45.000 ° | Withdrawn |
| 32125 | Withdrawn | |
| 32123 | Withdrawn | |
| 34737 | Length 45.000 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252197 | 2026-02-18 |
| K243834 | 2025-08-25 |
| K212125 | 2021-09-24 |
| K202344 | 2020-11-16 |
| K173418 | 2019-02-21 |
| K183069 | 2018-12-04 |
| K172352 | 2017-10-20 |
| K170135 | 2017-05-11 |
| K161598 | 2017-03-14 |
| K160119 | 2016-06-02 |
| K152836 | 2016-04-11 |
| K152093 | 2016-03-16 |
| K142260 | 2015-05-11 |
| K133731 | 2014-05-08 |
| K102436 | 2010-12-09 |
| K083205 | 2009-02-13 |
| K081128 | 2008-11-07 |
| K070857 | 2007-12-28 |
| K072980 | 2007-12-20 |
| K071370 | 2007-08-03 |
| K070182 | 2007-04-04 |
| K061971 | 2007-03-06 |
| K063718 | 2007-01-05 |
| K062936 | 2006-12-19 |
| K061003 | 2006-06-30 |
| K050406 | 2005-06-08 |
| K050705 | 2005-05-19 |
| K050393 | 2005-05-04 |
| K050258 | 2005-04-19 |
| K030685 | 2004-02-06 |
| K022562 | 2002-10-11 |
Recalls
2 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 |
|---|---|---|---|---|
| 2025-01-10 | Class II | Process control | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product. | 1,558 units (90 units – U.S.) |
| 2022-07-25 | Class II | Process change control | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. | 347 devices |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.