# K070601: Mini Drive-Lock Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Intra-Lock International
- Decided: Oct 12, 2007 after 224 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: 1 generation back to K021045 (2002). 3 ancestors in all.
144 later devices descend from it; 7 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040143: Monorail, Nats Corp. (2004) Summary page 1.
- K021045: Era Implant, Sterngold (2002) Summary page 1.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.

## Most influential descendants
- K073343: Ace Surgical Secure-Mini Implant System, Model 09-270X-XX (2008), 135 descendants of its own
- K092594: Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OX (2009), 134 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

## Indications for use
Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

Source page: https://510kreport.com/device/K070601
Methodology: https://510kreport.com/methodology