NobelParallel™ S TiUnite®
The FDA filing specifically identifies NobelParallel™ S TiUnite® in the Nobel Biocare S Series implant family. The implant is intended for placement in the upper or lower jaw to anchor or…
The FDA filing specifically identifies NobelParallel™ S TiUnite® in the Nobel Biocare S Series implant family.
The implant is intended for placement in the upper or lower jaw to anchor or support tooth replacements.
Listed Item
NobelParallel™ S TiUnite® NP 3.75×11.5mm
Restoration Configurations
The filing states that this implant line can support single or multiple-unit restorations in splinted or non-splinted applications. It describes use with two-stage or one-stage surgical techniques and immediate, early or delayed loading protocols when primary stability requirements are met.
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 |
| 510(k) | K252197 |
| Record published | 2026-02-26 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Sizes | Length 7 to 18 mm; outer diameter 3.75 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302370 | Length 13.000 mm | In distribution |
| 302368 | Length 10.000 mm | In distribution |
| 302390 | Length 7.000 mm | In distribution |
| 302371 | Outer Diameter 3.750 mm | In distribution |
| 302379 | Length 18.000 mm | In distribution |
| 302369 | Length 11.500 mm | In distribution |
| 302372 | Outer Diameter 3.750 mm | In distribution |
| 302391 | Outer Diameter 5.500 mm | In distribution |
| 302374 | Outer Diameter 4.300 mm | In distribution |
| 302392 | Outer Diameter 5.500 mm | In distribution |
| 302373 | Outer Diameter 4.300 mm | In distribution |
| 302387 | Outer Diameter 5.000 mm | In distribution |
| 302385 | Outer Diameter 5.000 mm | In distribution |
| 302394 | Length 13.000 mm | In distribution |
| 302386 | Outer Diameter 5.000 mm | In distribution |
| 302375 | Length 10.000 mm | In distribution |
| 302367 | Length 8.500 mm | In distribution |
| 302393 | Length 11.500 mm | In distribution |
| 302384 | Length 8.500 mm | In distribution |
| 302378 | Length 15.000 mm | In distribution |
| 302388 | Outer Diameter 5.000 mm | In distribution |
| 302366 | Outer Diameter 3.750 mm | In distribution |
| 302383 | Outer Diameter 5.000 mm | In distribution |
| 302389 | Outer Diameter 5.000 mm | In distribution |
| 302376 | Outer Diameter 4.300 mm | In distribution |
| 302395 | Length 15.000 mm | In distribution |
| 302377 | Outer Diameter 4.300 mm | In distribution |
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.