510(k) · Cleared
ClearedIps Inline Pom System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EIH Powder, Porcelain
Cleared on Aug 30, 2007 as substantially equivalent to K041335 (Dentsply International, 2004) after a 56-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 30, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940252 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK940252 Finesse Porcelain SystemDentsply Intl. · 1994
- 1 generation backK041335 PTM SystemDentsply International · 2004
- This deviceK071848 Ips Inline Pom SystemIvoclar Vivadent, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK152103 IPS Style Ceram, IPS Style Ceram One, IPS Style PressIvoclar Vivadent, AG · 2016
- Descendant · cites it directly · 0 of its ownK123613 Synspar AdvancedArdent, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK090434 Bece PressBego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · 2009
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 |
|---|---|---|---|---|---|
| −2 | K940252 | Finesse Porcelain System | Dentsply Intl. | 1994 | — |
| −1 | K041335 | PTM System | Dentsply International | 2004 | — |
| 0 (this device) | K071848 | Ips Inline Pom System | Ivoclar Vivadent, Inc. | 2007 | — |
| +1 | K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | Ivoclar Vivadent, AG | 2016 | — |
| +1 | K123613 | Synspar Advanced | Ardent, Inc. | 2013 | — |
| +1 | K090434 | Bece Press | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 EIH? 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 EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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 |
|---|---|---|---|
| * | K041335 | PTM SystemSummary page 1…IPS InLine PoM System Classification Name: Porcelain Powder for Clinical Use (872.6660) Predicate Devices: PTM System by Dentsply (K041335) Device Description: IPS InLine PoM is a dental porcelain system composed of a leucite-ceramic which utilizes a press-on… | 2004 |
What descends from it? (3)
3 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152103 (Ivoclar Vivadent, AG, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, 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 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer, mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10-6 K-' 25-500 °C The material is contraindicated for: * Pressing over metal frameworks beyond the CTE range * Very deep sub-gingival preparations * Patients with substantially reduced residual dentition * Patients with bruxism and * Use…
Read the full statement (142 words)
IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer, mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10-6 K-' 25-500 °C
The material is contraindicated for:
* Pressing over metal frameworks beyond the CTE range
* Very deep sub-gingival preparations
* Patients with substantially reduced residual dentition
* Patients with bruxism and
* Use with alloys with a silver content of more than 10%
Other limitations of use:
· Combination with any other ceramic materials
* Pressing IPS InLine PoM ingots thinner than 0.8mm
· Pressing of IPS InLine PoM ingots without a metal framework
Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials
Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071848: Ips Inline Pom System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071848
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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