510(k) · Cleared
ClearedDiplomat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diplomat Dental S.R.O. · EIA Unit, Operative Dental
Cleared on Oct 30, 2013 as substantially equivalent to K032543 (Sirona Dental Systems GmbH, 2003) after a 243-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 30, 2013
- Review
- 243 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962071 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 2 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 1 generation backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- This deviceK130534 DiplomatDiplomat Dental S.R.O. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −2 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −1 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K130534 | Diplomat | Diplomat Dental S.R.O. | 2013 | — |
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? (1)
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 |
|---|---|---|---|
| * | K032543 | Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSummary page 3…DIPLOMAT DENTAL have been shown to be Substantially Equivalent to the C8+Dental Operative Units manufactured by Sirona Dental Systems previously cleared by the FDA under K032543. The applicant and predicate devices are very similar in overall design and technology; principle of operation, intended use, mat… | 2003 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K032543.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without…
Read the full statement (144 words)
Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are Intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist If permitted by applicable law.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130534: Diplomat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130534
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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