Neodent
Easy Pack Helix GM Acqua 5.0X11.5 / Smart Abutment 5.5X1.5
7manufacturers in China registered for this device type
920catalogue numbers in this listing
4510(k) clearances naming this product 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 | Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K203382 |
| Record published | 2017-08-18 |
| Record revised | 2023-12-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Room temperature |
| Sizes | Outer diameter 2.9 to 7 mm; length 4 to 55 mm; height 1 to 6 mm; lumen/inner diameter 3.75 to 7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 109.985 | Outer Diameter 4 mm | In distribution |
| 140.923 | Outer Diameter 5 mm | In distribution |
| 180006 | Outer Diameter 4.3 mm | In distribution |
| 116.022 | Height 3 mm | In distribution |
| 138.078 | Outer Diameter 4.3 mm | In distribution |
| 109.666 | Outer Diameter 3.75 mm | In distribution |
| 140.1059 | Outer Diameter 7 mm | In distribution |
| 140.792 | Outer Diameter 4.3 mm | In distribution |
| 138.122 | Outer Diameter 3.75 mm | In distribution |
| 109.304 | Length 13 mm | In distribution |
| 140.1075 | Length 5.5 mm | In distribution |
| 109.921 | Length 8 mm | In distribution |
| 109.982 | Outer Diameter 4 mm | In distribution |
| 115.192 | Height 2.5 mm | In distribution |
| 109.153 | Outer Diameter 4.1 mm | In distribution |
| 140.957 | Length 16 mm | In distribution |
| 109.1094 | Outer Diameter 3.5 mm | In distribution |
| 138.030 | Outer Diameter 3.75 mm | In distribution |
| 140.669 | Length 15 mm | In distribution |
| 140.961 | Outer Diameter 3.5 mm | In distribution |
| 118.106 | Outer Diameter 4.1 mm | In distribution |
| 114.180 | Height 4 mm | In distribution |
| 109.648 | Outer Diameter 4.3 mm | In distribution |
| 140.1068 | Lumen/Inner Diameter 4.0 mm | In distribution |
| 109.612 | Outer Diameter 3.75 mm | In distribution |
| 109.303 | Outer Diameter 4 mm | In distribution |
| 140.737 | Length 10 mm | In distribution |
| 138.175 | Outer Diameter 5 mm | In distribution |
| 138.158 | Outer Diameter 4.3 mm | In distribution |
| 140.959 | Length 10 mm | In distribution |
| 140.924 | Length 13 mm | In distribution |
| 115.194 | Height 1.5 mm | In distribution |
| 116.021 | Height 2 mm | In distribution |
| 138.118 | Outer Diameter 3.75 mm | In distribution |
| 109.973 | Outer Diameter 5 mm | In distribution |
| 138.023 | Outer Diameter 3.5 mm | In distribution |
| 109.1089 | Outer Diameter 3.5 mm | In distribution |
| 114.029 | Outer Diameter 5 mm | In distribution |
| 109.584 | Outer Diameter 4.1 mm | In distribution |
| 109.583 | Outer Diameter 4.1 mm | In distribution |
| 109.922 | Outer Diameter 5 mm | In distribution |
| 140.947 | Outer Diameter 3.5 mm | In distribution |
| 109.952 | Outer Diameter 4.3 mm | In distribution |
| 109.1005 | Outer Diameter 3.5 mm | In distribution |
| 138.045 | Outer Diameter 3.75 mm | In distribution |
| 109.1078 | Length 4.0 mm | In distribution |
| 109.1003 | Length 11.5 mm | In distribution |
| 109.1056 | Length 50 mm | In distribution |
| 140.690 | Length 8 mm | In distribution |
| 140.948 | Outer Diameter 4.3 mm | In distribution |
| 109.1069 | Length 8.5 mm | In distribution |
| 109.688 | Length 10 mm | In distribution |
| 138.035 | Outer Diameter 3.75 mm | In distribution |
| 109.641 | Length 19 mm | In distribution |
| 140.651 | Length 16 mm | In distribution |
| 140.1067 | Length 5.5 mm | In distribution |
| 109.1006 | Outer Diameter 3.5 mm | In distribution |
| 140.592 | Outer Diameter 4 mm | In distribution |
| 140.990 | Outer Diameter 5 mm | In distribution |
| 138.125 | Outer Diameter 3.75 mm | In distribution |
| 109.896 | Length 18 mm | In distribution |
| 109.524 | Length 40 mm | In distribution |
| 140.640 | Length 17 mm | In distribution |
| 109.808 | Length 17 mm | In distribution |
| 109.306 | Outer Diameter 4 mm | In distribution |
| 140.752 | Length 8 mm | In distribution |
| 138.179 | Outer Diameter 5 mm | In distribution |
| 140.1073 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 138.011 | Outer Diameter 3.5 mm | In distribution |
| 109.991 | Length 11.5 mm | In distribution |
| 109.998 | Length 13 mm | In distribution |
| 109.642 | Outer Diameter 5 mm | In distribution |
| 109.454 | Length 52.5 mm | In distribution |
| 140.588 | Outer Diameter 4.1 mm | In distribution |
| 138.182 | Outer Diameter 5 mm | In distribution |
| 106.095 | Outer Diameter 4.1 mm | In distribution |
| 115.197 | Height 1 mm | In distribution |
| 138.143 | Outer Diameter 4 mm | In distribution |
| 138.079 | Outer Diameter 4.3 mm | In distribution |
| 109.101 | Length 13 mm | In distribution |
| 109.659 | Length 11.5 mm | In distribution |
| 109.450 | Length 35 mm | In distribution |
| 109.613 | Outer Diameter 3.5 mm | In distribution |
| 138.110 | Outer Diameter 3.75 mm | In distribution |
| 118.008 | Outer Diameter 3.3 mm | In distribution |
| 135.001 | Outer Diameter 3.3 mm | In distribution |
| 109.990 | Outer Diameter 5 mm | In distribution |
| 138.180 | Outer Diameter 5 mm | In distribution |
| 109.1057 | Outer Diameter 4.0 mm | In distribution |
| 109.1103 | Length 50 mm | In distribution |
| 109.948 | Outer Diameter 4.3 mm | In distribution |
| 138.013 | Outer Diameter 3.5 mm | In distribution |
| 109.1098 | Length 37.5 mm | In distribution |
| 109.619 | Length 17 mm | In distribution |
| 109.652 | Length 8 mm | In distribution |
| 140.973 | Length 13 mm | In distribution |
| 109.947 | Outer Diameter 3.5 mm | In distribution |
| 102.094 | Outer Diameter 4.3 mm | In distribution |
| 118.152 | Outer Diameter 4.3 mm | In distribution |
| 109.1100 | Outer Diameter 3.75 mm | In distribution |
| 109.1009 | Outer Diameter 6 mm | In distribution |
| 109.646 | Outer Diameter 5 mm | In distribution |
| 138.120 | Outer Diameter 3.75 mm | In distribution |
| 109.1058 | Length 55 mm | In distribution |
| 140.775 | Outer Diameter 4.1 mm | In distribution |
| 109.909 | Length 11 mm | In distribution |
| 109.1059 | Outer Diameter 7 mm | In distribution |
| 138.066 | Outer Diameter 4 mm | In distribution |
| 109.658 | Length 10 mm | In distribution |
| 109.953 | Outer Diameter 5 mm | In distribution |
| 118.041 | Height 2 mm | In distribution |
| 109.218 | Length 13 mm | In distribution |
| 109.592 | Outer Diameter 4.1 mm | In distribution |
| 138.160 | Outer Diameter 4.3 mm | In distribution |
| 109.924 | Outer Diameter 5 mm | In distribution |
| 109.919 | Length 17 mm | In distribution |
| 138.051 | Outer Diameter 4 mm | In distribution |
| 140.1066 | Lumen/Inner Diameter 4.0 mm | In distribution |
| 140.908 | Length 9 mm | In distribution |
| 109.686 | Length 13 mm | In distribution |
| 109.140 | Outer Diameter 3.3 mm | In distribution |
| 109.946 | Outer Diameter 3.5 mm | In distribution |
| 109.1067 | Lumen/Inner Diameter 4.0 mm | In distribution |
| 140.1071 | Length 5.5 mm | In distribution |
| 138.046 | Outer Diameter 3.75 mm | In distribution |
| 138.105 | Outer Diameter 3.5 mm | In distribution |
| 109.951 | Length 13 mm | In distribution |
| 118.007 | Outer Diameter 5 mm | In distribution |
| 109.944 | Length 10 mm | In distribution |
| 109.1012 | Length 13 mm | In distribution |
| 109.631 | Length 8 mm | In distribution |
| 109.1096 | Outer Diameter 3.75 mm | In distribution |
| 106.140 | Height 2 mm | In distribution |
| 109.900 | Length 8 mm | In distribution |
| 109.788 | Outer Diameter 3.3 mm | In distribution |
| 118.037 | Outer Diameter 4.1 mm | In distribution |
| 109.904 | Length 15 mm | In distribution |
| 109.1085 | Lumen/Inner Diameter 3.75 mm | In distribution |
| 138.137 | Outer Diameter 4 mm | In distribution |
| 140.922 | Length 9 mm | In distribution |
| 109.607 | Outer Diameter 3.75 mm | In distribution |
| 109.799 | Outer Diameter 5 mm | In distribution |
| 138.054 | Outer Diameter 4 mm | In distribution |
| 106.142 | Outer Diameter 4.3 mm | In distribution |
| 109.742 | Length 8 mm | In distribution |
| 118.217 | Outer Diameter 4.1 mm | In distribution |
| 109.324 | Outer Diameter 5 mm | In distribution |
| 118.219 | Outer Diameter 5 mm | In distribution |
| 109.779 | Length 19 mm | In distribution |
| 109.693 | Length 11.5 mm | In distribution |
| 138.130 | Outer Diameter 3.75 mm | In distribution |
| 109.798 | Outer Diameter 5 mm | In distribution |
| 140.911 | Length 15 mm | In distribution |
| 140.1009 | Outer Diameter 6 mm | In distribution |
| 109.528 | Length 52.5 mm | In distribution |
| 109.780 | Length 9 mm | In distribution |
| 102.061 | Height 3 mm | In distribution |
| 138.017 | Outer Diameter 3.5 mm | In distribution |
| 109.586 | Outer Diameter 3.75 mm | In distribution |
| 140.686 | Length 13 mm | In distribution |
| 138.060 | Outer Diameter 4 mm | In distribution |
| 102.095 | Outer Diameter 5 mm | In distribution |
| 109.918 | Outer Diameter 4 mm | In distribution |
| 115.053 | Height 3 mm | In distribution |
| 118.002 | Outer Diameter 3.3 mm | In distribution |
| 109.287 | Outer Diameter 4.1 mm | In distribution |
| 109.100 | Outer Diameter 5 mm | In distribution |
| 109.989 | Outer Diameter 4.3 mm | In distribution |
| 109.636 | Length 9 mm | In distribution |
| 140.798 | Outer Diameter 5 mm | In distribution |
| 138.113 | Outer Diameter 3.75 mm | In distribution |
| 109.916 | Outer Diameter 4 mm | In distribution |
| 109.685 | Outer Diameter 5 mm | In distribution |
| 180.013 | Length 5 mm | In distribution |
| 109.1102 | Length 47.5 mm | In distribution |
| 140.637 | Length 11 mm | In distribution |
| 109.987 | Length 18 mm | In distribution |
| 138.141 | Outer Diameter 4 mm | In distribution |
| 138.116 | Outer Diameter 3.75 mm | In distribution |
| 109.099 | Length 9 mm | In distribution |
| 140.783 | Length 15 mm | In distribution |
| 109.975 | Outer Diameter 5 mm | In distribution |
| 140.1012 | Outer Diameter 6 mm | In distribution |
| 109.151 | Outer Diameter 3.75 mm | In distribution |
| 140.910 | Length 13 mm | In distribution |
| 118.119 | Outer Diameter 4.3 mm | In distribution |
| 102.064 | Height 3 mm | In distribution |
| 109.1002 | Length 8 mm | In distribution |
| 109.784 | Length 17 mm | In distribution |
| 140.657 | Length 8 mm | In distribution |
| 138.090 | Outer Diameter 3.5 mm | In distribution |
| 109.1070 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 140.583 | Outer Diameter 4.1 mm | In distribution |
| 109.786 | Outer Diameter 3.3 mm | In distribution |
| 109.328 | Length 11 mm | In distribution |
| 109.691 | Length 11.5 mm | In distribution |
| 138.019 | Outer Diameter 3.5 mm | In distribution |
| 138.191 | Outer Diameter 5 mm | In distribution |
| 109.920 | Length 7 mm | In distribution |
| 109.787 | Length 10 mm | In distribution |
| 138.097 | Outer Diameter 3.5 mm | In distribution |
| 118.006 | Outer Diameter 5 mm | In distribution |
| 140.763 | Outer Diameter 5 mm | In distribution |
| 138.095 | Outer Diameter 3.5 mm | In distribution |
| 138.162 | Outer Diameter 4.3 mm | In distribution |
| 138.003 | Outer Diameter 3.5 mm | In distribution |
| 109.967 | Outer Diameter 4.3 mm | In distribution |
| 140.621 | Outer Diameter 3.5 mm | In distribution |
| 109.981 | Length 18 mm | In distribution |
| 138.031 | Outer Diameter 3.75 mm | In distribution |
| 109.801 | Outer Diameter 4.5 mm | In distribution |
| 115.134 | Height 1 mm | In distribution |
| 138.026 | Outer Diameter 3.75 mm | In distribution |
| 109.628 | Length 13 mm | In distribution |
| 138.155 | Outer Diameter 4 mm | In distribution |
| 109.914 | Length 8 mm | In distribution |
| 106.099 | Outer Diameter 5 mm | In distribution |
| 109.647 | Outer Diameter 4.3 mm | In distribution |
| 109.1011 | Outer Diameter 6 mm | In distribution |
| 140.755 | Length 13 mm | In distribution |
| 109.979 | Outer Diameter 3.75 mm | In distribution |
| 106.051 | Outer Diameter 4.1 mm | In distribution |
| 140.920 | Outer Diameter 5 mm | In distribution |
| 117.018 | Outer Diameter 4.1 mm | In distribution |
| 109.593 | Outer Diameter 4 mm | In distribution |
| 109.687 | Length 16 mm | In distribution |
| 140.778 | Outer Diameter 4.1 mm | In distribution |
| 138.028 | Outer Diameter 3.75 mm | In distribution |
| 113.047 | Outer Diameter 5 mm | In distribution |
| 180.015 | Outer Diameter 5 mm | In distribution |
| 109.1093 | Outer Diameter 3.5 mm | In distribution |
| 115.199 | Height 3 mm | In distribution |
| 109.630 | Outer Diameter 4 mm | In distribution |
| 118.204 | Outer Diameter 4.1 mm | In distribution |
| 116.017 | Height 1 mm | In distribution |
| 106.068 | Height 5 mm | In distribution |
| 138.081 | Outer Diameter 4.3 mm | In distribution |
| 109.782 | Length 13 mm | In distribution |
| 140.949 | Outer Diameter 4.3 mm | In distribution |
| 109.614 | Outer Diameter 3.5 mm | In distribution |
| 138.043 | Outer Diameter 3.75 mm | In distribution |
| 138.183 | Outer Diameter 5 mm | In distribution |
| 140.1061 | Outer Diameter 7 mm | In distribution |
| 140.795 | Outer Diameter 4.3 mm | In distribution |
| 138.124 | Outer Diameter 3.75 mm | In distribution |
| 106.092 | Height 2 mm | In distribution |
| 109.219 | Outer Diameter 3.3 mm | In distribution |
| 140.659 | Outer Diameter 3.5 mm | In distribution |
| 138.192 | Outer Diameter 5 mm | In distribution |
| 140.754 | Outer Diameter 3.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252090 | 2025-12-12 |
| K250271 | 2025-08-18 |
| K232099 | 2023-10-31 |
| K203309 | 2021-07-06 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Straumann USA, LLC | 510(k) number | 2021-11-30 | Class II | Packaging change control | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant | 7 pieces | 2025-02-05 |
| Straumann USA, LLC | 510(k) number | 2021-11-30 | Class II | Packaging change control | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant | 1 unit | 2025-02-05 |
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.