510(k) · Cleared
ClearedProcera Allceram Fusing Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · EIH Powder, Porcelain
Cleared on Nov 18, 1998 as substantially equivalent to K913644 (Vident, 1992) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Nov 18, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920887 (1992). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920887 GDC-3338, Dental Solder AlloyDeringer-Ney, Inc. · 1992
- This deviceK983453 Procera Allceram Fusing MaterialNobel Biocare Uas, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK253191 DCMhotbond zirconDental Creativ Management GmbH · 2026
- Descendant · cites it directly · 0 of its ownK020269 Procera Allceram Bridge MaterialProcera Sandvik AB · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920887 | GDC-3338, Dental Solder Alloy | Deringer-Ney, Inc. | 1992 | — |
| 0 (this device) | K983453 | Procera Allceram Fusing Material | Nobel Biocare Uas, Inc. | 1998 | — |
| +1 | K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026 | — |
| +1 | K020269 | Procera Allceram Bridge Material | Procera Sandvik AB | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K913644 | Vita in-CeramSummary page 1…pontic, which Porcelain All Ceram is applied to the surface. C. The Predicate Product The predicate products used in this Pre-market Notification are Vita In- Ceram (K#913644) Manufactured by Vident and Gdc-3338, Dental Solder Alloy (K#920887) manufactured by J.M. Ney. D. Description of Device The Nob… | 1992 |
| * | K920887 | GDC-3338, Dental Solder AlloySummary page 1…Predicate Product The predicate products used in this Pre-market Notification are Vita In- Ceram (K#913644) Manufactured by Vident and Gdc-3338, Dental Solder Alloy (K#920887) manufactured by J.M. Ney. D. Description of Device The Nobel Biocare Procera® All Ceram Fusing Material is a glass powder, whi… | 1992 |
What descends from it? (2)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K253191 (Dental Creativ Management GmbH, 2026) 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.
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?
Nobel Biocare’s Procera® AllCeram Fusing Material is a glass based powder which is mixed with distilled water. It is intended to be used to fuse together the sections of an aluminum oxide dental bridge.
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/K983453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983453: Procera Allceram Fusing Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983453
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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