# K063364: Alpha Bio Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Bio Tec, Ltd.
- Decided: Mar 14, 2007 after 127 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960026 (1996). 75 ancestors in all.
187 later devices descend from it; 13 cite it directly.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 2.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002) Summary page 2.
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 2.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 2.
- K003191: Mis Implant System Decive, Mis Implants Technologies, Ltd. (2001) Summary page 2.
- K041938: Maximus OS (Overdenture System), BioHorizons Implant Systems, Inc. (2004) Summary page 2.
- K032351: The Maestro System 3.0MM Diameter Implant, BioHorizons Implant Systems, Inc. (2003) Summary page 2.
- K041876: Nobeldirect OD Implant, Nobel Biocare Uas, Inc. (2004) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2.
- K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8, Imtec Corp. (2002) Summary page 2.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 2.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 2.
- K013798: Prosthetic Accessories to the Iti Dental Implant System, Institut Straumann AG (2001) Summary page 2.
- K002188: Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/Opar,Opb 8,10,12,14/OP2.3D/OP2.8D,, Core-Vent Corp. (2000) Summary page 2.

## Most influential descendants
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own

## Indications for use
The Alpha-Bio Dental implant System® isindicated for use in surgical and restorative applications for placement in the bone of the upper or lowerjaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function, Two stage: ATID, DI, SPI, 8FB, ATIE OF, ITO, SPR One stage: ITO, SPR One stage and One Piece: ARRP, ARPB, ARRC 3 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible they are also Indicated for denture stabilization using multiple implants One stage and One Piece for temporary or long-term use: ARR, ARB, ARS, ARBS are self tapping titanium threaded screws indicated for long term intr bony applications. They permit immedate splint stabilty and longterm fixation of new or existing crown, bridge and pro:heths, and protection o graft sites DFI, SPI, ARRP, ARPB and ARRC designs are Indicated for immediate loading when good primary stability is achieved and with appropriate occiusal loading. SPI and $FB designs are hidIlated for irhmediatt loading in single tooth restorations when good primary stabity is achieved and with appropriate cddiusai loading.

Source page: https://510kreport.com/device/K063364
Methodology: https://510kreport.com/methodology