# K972101: Solitaire

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Sep 29, 1997 after 117 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 4, 2008 · Not classified · Z-2187-2009: The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal
- Dec 4, 2008 · Not classified · Z-2179-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2186-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2200-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2203-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2183-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2185-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2184-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2205-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2191-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2193-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2194-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2204-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2197-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2206-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2192-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2189-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2181-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2198-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2195-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2180-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2196-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2188-2009: The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal
- Dec 4, 2008 · Not classified · Z-2201-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2207-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2199-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2190-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2182-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2202-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 

## Indications for use
Solitaire is a light-curing, fluoride releasing radiopaque polyglas composite. Together with the Solid bond adhesive bonding system, it is indicated for adhesive cavity filling therapy. Its applications include: Class I & II (Black) Cavities Class V Fillings (Black) Deciduous Tooth Reconstruction Stump Rebuilding

Source page: https://510kreport.com/device/K972101
Methodology: https://510kreport.com/methodology