# K021045: Era Implant

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold
- Decided: Jun 26, 2002 after 86 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
No predicates in its family tree.
145 later devices descend from it; 1 cites it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070601: Mini Drive-Lock Dental Implant System (2007), 144 descendants of its own
- 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

## Indications for use
The ERA Implant is intended for surgical placement in edentulous anterior regions of the maxillary andlor rnandibulaq arch to provide temporary support and permit immediate stability and ongoing fixation of new or existing crown and bridge applications, for full or partial dentures, with minimal invasive surgical intervention. Sterngoid's ERA Implant is indicated for use as a temporary, when placed between traditional implants to stabifize a denture during healing period.

Source page: https://510kreport.com/device/K021045
Methodology: https://510kreport.com/methodology