510(k) Report

510(k) · Cleared

Recalled · 2008

Solitaire

K972101510(k) TraditionalCleared Sep 29, 1997117-day reviewClass II21 CFR 872.3200Recalls 29

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heraeus Kulzer, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Sep 29, 1997 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 29 times.

Decided
Sep 29, 1997
Review
117 days
Class
Class II
Product code
KLE
Recalls
29
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K972101Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KLE device

  1. #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 4, 2008Not classifiedZ-2187-2009Nonconforming Material/ComponentThe 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 canal during use, necessitating…
Dec 4, 2008Not classifiedZ-2179-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2186-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2200-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2203-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2183-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2185-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2184-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2205-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2191-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2193-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2194-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2204-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2197-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2206-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2192-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2189-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2181-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2198-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2195-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2180-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2196-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2188-2009Nonconforming Material/ComponentThe 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 canal during use, necessitating…
Dec 4, 2008Not classifiedZ-2201-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2207-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2199-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2190-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2182-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…
Dec 4, 2008Not classifiedZ-2202-2009Nonconforming Material/ComponentSnare 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 the stomach or other internal canal…

The 5 latest of 29 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007: 142008: 32009: 72010: 82011: 102012: 52013: 112014: 62015: 102016: 32017: 42018: 82019: 62020: 62021: 42022: 82023: 62024: 72025: 32026 (partial year): 7
2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007: 71 days median2008: 66 days median2009: 79 days median2010: 93 days median2011: 100 days median2012: 66 days median2013: 115 days median2014: 120 days median2015: 118 days median2016: 148 days median2017: 171 days median2018: 124 days median2019: 143 days median2020: 195 days median2021: 163 days median2022: 98 days median2023: 75 days median2024: 61 days median2025: 149 days median2026 (partial year): 84 days median
2007high 195 (2020) · low 61 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KLE

1in 2024

2007: 22009: 12010: 12016: 12017: 12024: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLE

3in 2025

2007: 182008: 92009: 112010: 132011: 692012: 1762013: 2482014: 2602015: 1002016: 472017: 422018: 312019: 202020: 62021: 62022: 72023: 72024: 122025: 3
2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071471218
200836609
2009779111
2010893113
201110100069
20125660176
2013111150248
201461200260
2015101180100
20163148147
20174171142
20188124031
20196143020
2020619506
2021416306
202289807
202367507
2024761112
2025314903
20267840—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Heraeus Kulzer, Inc.

145 FDA decisions under this applicant name. See the company

  • K091494Flexitime FlowHeraeus Kulzer, Inc. · 2009
  • K063062Hkbond 2006Heraeus Kulzer, Inc. · 2006
  • K060994MondialHeraeus Kulzer, Inc. · 2006
  • K052543Heraceram ZirkoniaHeraeus Kulzer, Inc. · 2005
  • K043504PalaimpactHeraeus Kulzer, Inc. · 2005

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The KLE category page

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https://510kreport.com/device/K972101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972101: Solitaire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972101

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026