Intra-Lock
Intra-Lock is a dental implant family for supporting fixed or removable tooth replacements in the upper or lower jaw. The implants are threaded, root-form devices with an internal…
Intra-Lock is a dental implant family for supporting fixed or removable tooth replacements in the upper or lower jaw. The implants are threaded, root-form devices with an internal connection for a prosthetic abutment.
The range includes straight and tapered implant bodies and different collar configurations. A listed Blossom Intrahex short-collar implant is one example within the implant-and-restoration family.
Listed Item
Blossom™ Intrahex, Ø3.4mm x 11.5mm Implant, Short Collar + Cover Screw
Collar and Material Options
Short bone-level and longer tissue-level collars use horizontal microthreads. Materials across the described implant range include titanium alloy and commercially pure titanium. The abutment mates with the implant’s internal connection, linking the bone-anchored fixture to the prosthetic restoration.
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 | Intra-Lock International, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K133613 |
| Record published | 2017-02-07 |
| Record revised | 2025-06-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-05-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IC5015TI | In distribution | |
| FTCRS | In distribution | |
| IS3711TI | In distribution | |
| IH3710 | In distribution | |
| IC5013TI | In distribution | |
| FATIBASE | In distribution | |
| IC4310STI | In distribution | |
| IHCT4011 | In distribution | |
| IH4011 | In distribution | |
| IC4313TI | In distribution | |
| IHCT4011 | In distribution | |
| I4711TI | In distribution | |
| IH3708 | In distribution | |
| FTARS | In distribution | |
| IH3408 | In distribution | |
| IH4013 | In distribution | |
| IH3413 | In distribution | |
| IC4313TI | In distribution | |
| I4708TI | In distribution | |
| IHCT4010 | In distribution | |
| IHCT4010 | In distribution | |
| FANTIBASE | In distribution | |
| FASCBA | In distribution | |
| IHCT4015 | In distribution | |
| I4713TI | In distribution | |
| H4010TI | In distribution | |
| IH6008 | In distribution | |
| H3715TI | In distribution | |
| IHCT4711 | In distribution | |
| IC4315STI | In distribution | |
| IC5011STI | In distribution | |
| H4008TI | In distribution | |
| IH4010 | In distribution | |
| IC5013STI | In distribution | |
| IHCT4713 | In distribution | |
| IH3715 | In distribution | |
| IC5011TI | In distribution | |
| H4013TI | In distribution | |
| IH3715 | In distribution | |
| I4711TI | In distribution | |
| H4011TI | In distribution | |
| I4710TI | In distribution | |
| IH6006 | In distribution | |
| IC4310TI | In distribution | |
| IH3708 | In distribution | |
| FANSCBA | In distribution | |
| H3713TI | In distribution | |
| FTRS | In distribution | |
| IH3410 | In distribution | |
| IH3713 | In distribution | |
| IC4315TI | In distribution | |
| I4708TI | In distribution | |
| I4713TI | In distribution | |
| IHCT4711 | In distribution | |
| H3713TI | In distribution | |
| IHCT4713 | In distribution | |
| IC5011TI | In distribution | |
| IH4008 | In distribution | |
| IH3411 | In distribution | |
| IH3710 | In distribution | |
| IH3711 | In distribution | |
| FASTC | In distribution | |
| IH4708 | In distribution | |
| IHCT4710 | In distribution | |
| IC5015TI | In distribution | |
| H4015TI | In distribution | |
| IC4311TI | In distribution | |
| I4011STI | In distribution | |
| IH3711 | In distribution | |
| H4008TI | In distribution | |
| H4015TI | In distribution | |
| I4710TI | In distribution | |
| IHCT4013 | In distribution | |
| H4013TI | In distribution | |
| IH4008 | In distribution | |
| IS3715TI | In distribution | |
| IH6011 | In distribution | |
| IS3711L | In distribution | |
| IH3415 | In distribution | |
| IC4311STI | In distribution | |
| H4010TI | In distribution | |
| IC5010STI | In distribution | |
| H3715TI | In distribution | |
| IC5015STI | In distribution | |
| IH4706 | In distribution | |
| IH6010 | In distribution | |
| I4011STI | In distribution | |
| IH3713 | In distribution | |
| IC5013TI | In distribution | |
| IC4315TI | In distribution | |
| IC4313STI | In distribution | |
| IHCT4013 | In distribution | |
| IC4311TI | In distribution | |
| FANSTC | In distribution | |
| IHCT4710 | In distribution | |
| IS3713L | In distribution | |
| IS3713L | In distribution | |
| IHCT4015 | In distribution | |
| IS3713TI | In distribution | |
| H4011TI | In distribution | |
| IC5015STI | Withdrawn | |
| IC4315STI | Withdrawn | |
| IC5010STI | Withdrawn | |
| IC5011STI | Withdrawn | |
| IC4310STI | Withdrawn | |
| IS3713TI | Withdrawn | |
| IS3711TI | Withdrawn | |
| IC4313STI | Withdrawn | |
| IC5013STI | Withdrawn | |
| IS3715TI | Withdrawn | |
| IC4311STI | 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 |
|---|---|
| K133613 | 2014-03-20 |
| K130140 | 2013-08-01 |
| K103194 | 2011-04-21 |
| K070601 | 2007-10-12 |
| K050970 | 2005-10-14 |
| K031322 | 2003-12-23 |
| K021915 | 2002-12-19 |
| K021322 | 2002-07-24 |
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.