510(k) · Cleared
ClearedReline-IT Model Reline-IT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Majestic Drug Co., Inc. · EBP Reliner, Denture, Over The Counter
Cleared on Sep 20, 2010 as substantially equivalent to K790589 (Den-Mat Corp., 1979) after an 88-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Sep 20, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- EBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790589 (1979). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K121318ProsoftPerma Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790589 | Denture-Tight | Den-Mat Corp. | 1979 | — |
| 0 (this device) | K101771 | Reline-IT Model Reline-IT | Majestic Drug Co., Inc. | 2010 | — |
| +1 | K121318 | Prosoft | Perma Laboratories | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBP? 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K790589 | Denture-TightSummary page 2…tions "Conformance to Voluntary Standards" and "Clinical and Scientific Studies" Predicate Devices [21 CFR 807.92(a)(3)(1)J * DEN -MAT CORP "DENTURE-TIGHT' K790589 * LEE PHARMACEUTICALS "ACRYLfNE 2"( 510(k) unknown) * PERMA LABORATORIES PERMA SOFT II. (510(k) unknown) The subje… | 1979 |
| * | — | Acryline 2 Named without a submission number | |
| * | — | Perma Soft II Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121318 | Prosoft | 2012 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K121318 (Perma Laboratories, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBP devicesEBP Reliner, Denture, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EBP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EBP
Too few EBP 510(k)s in any year since 2007 to give a median.
Recalls per year · EBP
No recall names EBP since 2007.
Adverse event reports per year · EBP
1in 2025
MAUDE reports naming product code EBP, 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An over the counter temporary Denture Reliner, intended to replace a worn denture lining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101771: Reline-IT Model Reline-IT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101771
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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