Iphysio® Profile Designer
The iPhysio Profile Designer is a healing abutment that protects the dental implant’s internal connection and shapes the surrounding gum tissue during healing. It is screwed into a…
The iPhysio Profile Designer is a healing abutment that protects the dental implant’s internal connection and shapes the surrounding gum tissue during healing. It is screwed into a compatible implant and can remain in place during digital or conventional impressions to preserve the tissue profile.
The straight abutment is made from titanium alloy with a zirconium nitride coating. A compatible titanium screw secures it. Anatomical forms and gingival heights provide options for different tooth locations and tissue contours, including a molar form.
Listed Item
iphysio® Profile Designer Healing Abutment Size C1 and compatible screw
Use Period and Connection
The healing abutment is intended for use for up to six months and is not load bearing. It must match the specified implant connection; supported families include selected Nobel Biocare, Straumann Bone Level and Zimmer Biomet implants.
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 | Euroteknika, France |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K232383 |
| Record published | 2025-05-23 |
| Record revised | 2025-12-22 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature up to 30 °C |
| Sizes | Height 7.4 to 10.6 mm; length 5.2 to 7.65 mm; width 4.3 to 7.65 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NCCR_I.C1 | Height 7.7 mm | In distribution |
| SBLR_I.C2 | Height 9 mm | In distribution |
| ZSC35_I.A4 | Height 9.9 mm | In distribution |
| ZSC45_I.B1 | Height 7.4 mm | In distribution |
| ZSC35_I.D2 | Height 8.4 mm | In distribution |
| NCCR_I.B1 | Height 7.7 mm | In distribution |
| ZSC35_I.C2 | Height 8.4 mm | In distribution |
| ZSC35_I.A1 | Height 7.4 mm | In distribution |
| SBLR_I.D2 | Height 8.95 mm | In distribution |
| ZSC45_I.B3 | Height 9.4 mm | In distribution |
| NCCN_I.B1 | Height 7.8 mm | In distribution |
| SBLR_I.D1 | Height 8.15 mm | In distribution |
| NCCN_I.D4 | Height 10.38 mm | In distribution |
| ZSC35_I.D4 | Height 9.9 mm | In distribution |
| ZSC45_I.B2 | Height 8.4 mm | In distribution |
| SBLN_I.B1 | Height 8.2 mm | In distribution |
| NCCR_I.D2 | Height 8.67 mm | In distribution |
| ZSC35_I.A3 | Height 9.4 mm | In distribution |
| ZSC35_I.C3 | Height 9.4 mm | In distribution |
| NCCR_I.B4 | Height 10.3 mm | In distribution |
| ZSC45_I.D4 | Height 9.9 mm | In distribution |
| SBLR_I.C4 | Height 10.6 mm | In distribution |
| SBLR_I.D4 | Height 10.55 mm | In distribution |
| NCCR_I.C3 | Height 9.7 mm | In distribution |
| SBLN_I.D2 | Height 8.95 mm | In distribution |
| SBLN_I.A2 | Height 9 mm | In distribution |
| SBLN_I.B3 | Height 9.8 mm | In distribution |
| SBLR_I.D3 | Height 9.75 mm | In distribution |
| SBLR_I.B4 | Height 10.6 mm | In distribution |
| SBLR_I.B2 | Height 9 mm | In distribution |
| SBLR_I.C3 | Height 9.8 mm | In distribution |
| SBLR_I.C1 | Height 8.2 mm | In distribution |
| ZSC35_I.C1 | Height 7.4 mm | In distribution |
| NCCR_I.D1 | Height 7.67 mm | In distribution |
| ZSC45_I.D3 | Height 9.4 mm | In distribution |
| SBLN_I.A4 | Height 10.6 mm | In distribution |
| NCCN_I.A1 | Height 7.8 mm | In distribution |
| SBLN_I.B4 | Height 10.6 mm | In distribution |
| ZSC35_I.B4 | Height 9.9 mm | In distribution |
| ZSC45_I.C3 | Height 9.4 mm | In distribution |
| ZSC35_I.B2 | Height 8.4 mm | In distribution |
| ZSC35_I.B3 | Height 9.4 mm | In distribution |
| SBLN_I.D1 | Height 8.15 mm | In distribution |
| SBLR_I.B3 | Height 9.8 mm | In distribution |
| NCCN_I.D3 | Height 9.78 mm | In distribution |
| NCCN_I.D2 | Height 8.78 mm | In distribution |
| SBLR_I.B1 | Height 8.2 mm | In distribution |
| NCCN_I.A4 | Height 10.4 mm | In distribution |
| NCCR_I.C2 | Height 8.7 mm | In distribution |
| NCCN_I.A3 | Height 9.8 mm | In distribution |
| NCCR_I.D4 | Height 10.27 mm | In distribution |
| ZSC45_I.D2 | Height 8.4 mm | In distribution |
| ZSC45_I.B4 | Height 9.9 mm | In distribution |
| ZSC35_I.B1 | Height 7.4 mm | In distribution |
| ZSC45_I.C1 | Height 7.4 mm | In distribution |
| ZSC35_I.D3 | Height 9.4 mm | In distribution |
| ZSC45_I.C4 | Height 9.9 mm | In distribution |
| NCCN_I.B2 | Height 8.8 mm | In distribution |
| ZSC35_I.D1 | Height 7.4 mm | In distribution |
| NCCN_I.A2 | Height 8.8 mm | In distribution |
| NCCR_I.B3 | Height 9.7 mm | In distribution |
| SBLN_I.D4 | Height 10.55 mm | In distribution |
| SBLN_I.A3 | Height 9.8 mm | In distribution |
| ZSC35_I.A2 | Height 8.4 mm | In distribution |
| ZSC35_I.C4 | Height 9.9 mm | In distribution |
| ZSC45_I.C2 | Height 8.4 mm | In distribution |
| SBLN_I.B2 | Height 9 mm | In distribution |
| ZSC45_I.D1 | Height 7.4 mm | In distribution |
| NCCR_I.D3 | Height 9.67 mm | In distribution |
| NCCR_I.C4 | Height 10.3 mm | In distribution |
| SBLN_I.D3 | Height 9.75 mm | In distribution |
| SBLN_I.A1 | Height 8.2 mm | In distribution |
| NCCR_I.B2 | Height 8.7 mm | 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 |
|---|---|
| K232383 | 2025-03-04 |
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.