# K223535: SMARTbase Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jun 20, 2023 after 209 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191458: Legacy SMARTBase Abutments, Implant Direct Sybron Manufacturing, LLC (2019) Summary page 4.

## Recalls of this device
- May 2, 2023 · Class II · Z-2037-2023: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

## Indications for use
The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations. The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment. • SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. • SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. • SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Source page: https://510kreport.com/device/K223535
Methodology: https://510kreport.com/methodology