# K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment

- Pathway: 510(k) (Abbreviated)
- Applicant: A-Dec, Inc.
- Decided: Jan 7, 2009 after 104 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092446: Intra Lux Head 3 Ldsy (2009), 1 descendant of its own
- K242179: Synea Fusion Handpieces (Intensiv & Profin) (2025), 0 descendants of its own
- K221814: OK Handpiece (2022), 0 descendants of its own
- K101172: RDT3 Handpiece Head Model RDT3 (2010), 0 descendants of its own
- K090548: Contra-Angle Handpiece Komet OS30 (2009), 0 descendants of its own

## Indications for use
The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.

Source page: https://510kreport.com/device/K082827
Methodology: https://510kreport.com/methodology