Tatum Surgical/One Piece Small Ball Head Implant
One Piece Dental Implant 8.0mm diameter and 11mm in length small ball head
7manufacturers in China registered for this device type
32catalogue numbers in this listing
1510(k) clearance
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 | Suncoast Dental, Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K811923 |
| Record published | 2018-07-18 |
| Record revised | 2023-01-03 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 11 to 23 mm; outer diameter 3 to 8 mm |
| Distribution end date | 2023-01-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| One Piece/5.0 x 14SB | Length 14 mm | In distribution |
| One Piece/5.0 x 17SB | Outer Diameter 5 mm | In distribution |
| One Piece/3.5 x 17SB | Length 17 mm | In distribution |
| One Piece/3.0 x 11SB | Outer Diameter 3 mm | In distribution |
| One Piece/3.0 x 14SB | Outer Diameter 3 mm | In distribution |
| One Piece/3.5 x 11SB | Outer Diameter 3.5 mm | In distribution |
| One Piece/5.0 x 11SB | One Piece 5.0mm Diameter x 11mm Length SB | In distribution |
| One Piece/4.0 x 17SB | One Piece 4.0mm Diameter x 17mm Length SB | In distribution |
| One Piece/3.5 x 14SB | One Piece 3.5mm Diameter x 14mm Length SB | In distribution |
| One Piece/4.0 x 11SB | Outer Diameter 4 mm | In distribution |
| One Piece/3.0 x 17SB | Length 17 mm | In distribution |
| One Piece/4.0 x 14SB | Length 14 mm | In distribution |
| One Piece/8.0x11SB | Length 11 mm | Withdrawn |
| One Piece/3.5 x 20SB | Outer Diameter 3.5 mm | Withdrawn |
| One Piece/3.0 x 20SB | Outer Diameter 3 mm | Withdrawn |
| One Piece/3.0 x 23SB | One Piece 3.0mm Diameter x 23mm Length SB | Withdrawn |
| One Piece/8.0x14SB | One Piece 8.0mm Diameter x 14mm Length SB | Withdrawn |
| One Piece/3.5 x 23SB | Length 23 mm | Withdrawn |
| One Piece/7.0x14SB | Outer Diameter 7 mm | Withdrawn |
| One Piece/7.0x11SB | One Piece 7.0mm Diameter x 11mm Length SB | Withdrawn |
| One Piece/4.5x17SB | One Piece 4.5mm Diameter x 17mm Length SB | Withdrawn |
| One Piece/4.5x23SB | Length 23 mm | Withdrawn |
| One Piece/4.0x20SB | Outer Diameter 4 mm | Withdrawn |
| One Piece/4.5x14SB | One Piece 4.5mm Diameter x 14mm Length SB | Withdrawn |
| One Piece/4.5x11SB | Outer Diameter 4.5 mm | Withdrawn |
| One Piece/6.0x 14SB | Outer Diameter 6 mm | Withdrawn |
| One Piece/6.0 x 11SB | Outer Diameter 6 mm | Withdrawn |
| One Piece/6.0 x 17SB | One Piece 6.0mm Diameter x 17mm Length SB | Withdrawn |
| One Piece/4.0x23SB | Outer Diameter 4 mm | Withdrawn |
| One Piece/5.0x23SB | Outer Diameter 5 mm | Withdrawn |
| One Piece/4.5x20SB | One Piece 4.5mm Diameter x 20mm Length SB | Withdrawn |
| One Piece/5.0x20SB | One Piece 5.0mm Diameter x 20mm Length SB | 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 |
|---|---|
| K811923 | 1981-07-24 |
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.