510(k) · Cleared
ClearedOpaldam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · EIG Retractor, All Types
Cleared on Jun 3, 1997 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 3, 1997
- Review
- 57 days
- Class
- Class I
- Product code
- EIG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK971284 OpaldamUltradent Products, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK151945 Triumph Resin DamDenali Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK182118 armor LCMavrik Dental Systems, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK021613 Niveous Liquid DamShofu Dental Corp. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971284 | Opaldam | Ultradent Products, Inc. | 1997 | — |
| +1 | K151945 | Triumph Resin Dam | Denali Corporation | 2016 | — |
| +2 | K182118 | armor LC | Mavrik Dental Systems, Ltd. | 2019 | — |
| +1 | K021613 | Niveous Liquid Dam | Shofu Dental Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
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 EIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151945 (Denali Corporation, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EIG devicesEIG Retractor, All Types: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIG
FDA has decided no EIG device since 2007.
Median 510(k) review, days · EIG
Too few EIG 510(k)s in any year since 2007 to give a median.
Recalls per year · EIG
No recall names EIG since 2007.
Adverse event reports per year · EIG
2in 2025
MAUDE reports naming product code EIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) “power” bleaching agent.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971284: Opaldam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971284
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026