510(k) · Cleared
ClearedDimension Bite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · ELW Material, Impression
Cleared on Jun 18, 1999 as substantially equivalent to K954281 (Roydent Dental Products, Inc., 1996) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Jun 18, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K812116 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
- 1 generation backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- This deviceK991008 Dimension BiteEspe Dental AG · 1999
- Descendant · cites it directly · 0 of its ownK133400 Flash Bite3M Espe AG · 2014
Most influential descendants
Showing 1 of 1 · See all- K133400Flash Bite3M Espe AG · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| −1 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| 0 (this device) | K991008 | Dimension Bite | Espe Dental AG | 1999 | — |
| +1 | K133400 | Flash Bite | 3M Espe AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K954281 | Panasil Impression MaterialSummary page 1…ccccceveeeeenn. Impression material Common Name:.....ccccoeeveirimneinrecenen. Bite registration material Predicate Devices PANASIL® by Roydent..........cccccveennnee. K 954281 DIMENSION® PENTA by ESPE ............... K 960547 PERMADYNE® GARANT® by ESPE......... K 953374 Description for the Premarket Not… | 1996 |
| * | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveSummary page 1…...ccccoeeveirimneinrecenen. Bite registration material Predicate Devices PANASIL® by Roydent..........cccccveennnee. K 954281 DIMENSION® PENTA by ESPE ............... K 960547 PERMADYNE® GARANT® by ESPE......... K 953374 Description for the Premarket Notification DIMENSION® BITE is classified as an imp… | 1996 |
| * | K953374 | Permadyne Garant 2:1Summary page 1…n material Predicate Devices PANASIL® by Roydent..........cccccveennnee. K 954281 DIMENSION® PENTA by ESPE ............... K 960547 PERMADYNE® GARANT® by ESPE......... K 953374 Description for the Premarket Notification DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) beca… | 1995 |
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 |
|---|---|---|---|
| K133400 | Flash Bite | 2014 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133400 (3M Espe AG, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K954281.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
Bite registration
Intraoral guide pin excursion tracing
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/K991008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991008: Dimension Bite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991008
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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