# K102836: Bonasil a+ Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Dmp, Ltd.
- Decided: Jan 13, 2011 after 106 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K152180: PEAK (2015), 1 descendant of its own
- K180565: Peak NS033CF, Peak NS017CF (2018), 0 descendants of its own
- K143382: DentiAnn Smart Sil (2015), 0 descendants of its own

## Indications for use
The Bonasil At Impression Materials are intended to: - be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patent's teeth and gums; - provide models for study and for production of restorative prosthetics devices; *BONASIL At Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab putty) is to be used as a preliminary material for: -Two step putty/wash technique -Single step putty/wash technique -Functional peripheries -Crown/bridge work -Inlays, onlays *BONASIL A Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for -Two step putty/wash technique -Single step putty/wash technique -Functional peripheries -Crown/bridge work -Inlays, onlays *BONASIL A* Monophase (monophase normal set, manophase fast set) is to be used as* a semi-heavy body material for: -Single step putty/wash technique -Functional peripheries -Crown/bridge work -Inlays, onlays *BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for: -Two step putty/wash technique -Single step putty/wash technique -Functional peripheries -Reline impressions -Crown/bridge work -Inlays, onlays *BONASIL Ai Light (light normal set, light fast set) is to be used as a light body material for -Two step putty/wash technique -Single step putty/wash technique -Functional peripheries -Reline impressions -Crown/bridge work -Inlays, onlays *BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for: -Making accurate occlusal registrations -Standards bite registrations in the end bite position -Key material for needle point registration -Production of small model segments -An optical registration of occlusal data for CAD/CAM/CIM systems *BONASIL A' Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for -Preliminary impressions -Anatomic models -Fabricating temporary crowns and bridges -Opposing dentition -Fabricating simple removable prosthetic restorations -Orthodontic work -Case study models

Source page: https://510kreport.com/device/K102836
Methodology: https://510kreport.com/methodology