510(k) · Cleared
ClearedEradic-All
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratechnologies, Inc. · EIA Unit, Operative Dental
Cleared on Dec 2, 1998 as substantially equivalent to K971278 (Pure Co., 1997) and 3 other predicates after a 245-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 2, 1998
- Review
- 245 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930144 (1994). 4 ancestors in all, the oldest K882491 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930144 | The Scitech One-Day Filter | Scitech Solutions, Inc. | 1994 | — |
| −1 | K963548 | Dentapure Dental Unit Water Line Filter-Iodinated | Mrlb Intl., Inc. | 1997 | — |
| 0 (this device) | K981171 | Eradic-All | Theratechnologies, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K971278 | Pure Company Fluid Delivery SystemSummary page 1…R 872.6640. VII. Substantial Equivalence: Eradic-All™ is substantially equivalent to the classified device and those cleared for marketing by the S10(k) process under K-971278 (Pure Company, K-963548 (MRLB Int’l.) and K-930144 (SciTech Dental) and K-882491 (Micryllum Labs.) The “S10(k) Substantial Equiv… | 1997 |
| * | K963548 | Dentapure Dental Unit Water Line Filter-IodinatedSummary page 1…ntial Equivalence: Eradic-All™ is substantially equivalent to the classified device and those cleared for marketing by the S10(k) process under K-971278 (Pure Company, K-963548 (MRLB Int’l.) and K-930144 (SciTech Dental) and K-882491 (Micryllum Labs.) The “S10(k) Substantial Equivalence” Decision Making… | 1997 |
| * | K930144 | The Scitech One-Day FilterSummary page 1…ll™ is substantially equivalent to the classified device and those cleared for marketing by the S10(k) process under K-971278 (Pure Company, K-963548 (MRLB Int’l.) and K-930144 (SciTech Dental) and K-882491 (Micryllum Labs.) The “S10(k) Substantial Equivalence” Decision Making Process (Detailed) from ODE… | 1994 |
| * | K882491 | Cutting Fluid System for Dental High Speed DrillsSummary page 1…t to the classified device and those cleared for marketing by the S10(k) process under K-971278 (Pure Company, K-963548 (MRLB Int’l.) and K-930144 (SciTech Dental) and K-882491 (Micryllum Labs.) The “S10(k) Substantial Equivalence” Decision Making Process (Detailed) from ODE Guidance Memorandum # 36-3 wa… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K971278.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to
improve the quality of water supplied to dental handpieces.and other dental mstrumcnts
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981171: Eradic-All.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981171
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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