Infinity External Hex System
Prepable Abutment HX 3.5HD 2CH 4.5CW W/Screw #19502101 (TI6AL4VELI)
7manufacturers in China registered for this device type
33catalogue numbers in this listing
11510(k) clearances naming this product code
1recall
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 | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K954513 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 2 to 7.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01409413 | Width 7 mm | In distribution |
| 01402211 | Width 5.5 mm | In distribution |
| 08306004 | Width 7.5 mm | In distribution |
| 01409513 | Width 5.5 mm | In distribution |
| 03603012 | Width 3.5 mm | In distribution |
| 01409013 | Width 4.5 mm | In distribution |
| 19500501 | Width 3.5 mm | In distribution |
| 01409212 | Width 5.5 mm | In distribution |
| 01402112 | Width 4.5 mm | In distribution |
| 08429502 | Width 5.5 mm | In distribution |
| 08429001 | Width 4.5 mm | In distribution |
| 01402012 | Width 4.5 mm | In distribution |
| 01401501 | Width 5.5 mm | In distribution |
| 19501701 | Width 6 mm | In distribution |
| 19501501 | Width 5.75 mm | In distribution |
| 01402511 | Width 5.5 mm | In distribution |
| 01402011 | Width 4.5 mm | In distribution |
| 03603011 | Width 4.5 mm | In distribution |
| 01402911 | Width 6.5 mm | In distribution |
| 01402411 | Width 7 mm | In distribution |
| 01402811 | Width 7.5 mm | In distribution |
| 01409014 | Width 4.5 mm | In distribution |
| 01402111 | Width 4.5 mm | In distribution |
| 08429002 | Width 5.5 mm | In distribution |
| 01401001 | Width 2 mm | In distribution |
| 08429501 | Width 4.5 mm | In distribution |
| 08305004 | Width 6.5 mm | In distribution |
| 19501001 | Width 4 mm | In distribution |
| 01402611 | Width 6.5 mm | In distribution |
| 01409514 | Width 5.5 mm | In distribution |
| 01409213 | Width 5.5 mm | In distribution |
| 01402912 | Width 6.5 mm | In distribution |
| 01409412 | Width 7 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 |
|---|---|
| K103790 | 2011-08-18 |
| K102981 | 2010-12-20 |
| K093518 | 2010-01-14 |
| K092594 | 2009-09-16 |
| K073343 | 2008-03-13 |
| K080074 | 2008-02-14 |
| K041759 | 2004-07-22 |
| K021244 | 2002-05-03 |
| K002075 | 2001-02-02 |
| K954605 | 1996-06-05 |
| K954513 | 1996-06-05 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2017-02-22 | Class II | Labeling mix-ups | Incorrect device was packaged. | 87 | 2017-08-07 |
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.