# K081101: Spectra-System Abutments 2008

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Jan 14, 2009 after 272 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894595 (1990). 21 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061319: Spectra System, Implant Direct, LLC (2006)
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001)
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 1.

## Most influential descendants
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K191458: Legacy SMARTBase Abutments (2019), 1 descendant of its own

## Indications for use
Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.

Source page: https://510kreport.com/device/K081101
Methodology: https://510kreport.com/methodology