510(k) · Cleared
ClearedMultilink Hybrid Abutment Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EMA Cement, Dental
Cleared on Aug 20, 2013 as substantially equivalent to K090704 (Ivoclar Vivadent, Inc., 2009) after a 180-day review. Its family tree reaches back 1 generation to 2009. 5 later devices descend from it.
- Decided
- Aug 20, 2013
- Review
- 180 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090704 (2009). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK090704 Multilink ImplantIvoclar Vivadent, Inc. · 2009
- This deviceK130436 Multilink Hybrid Abutment CementIvoclar Vivadent, AG · 2013
- Descendant · cites it directly · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK240888 Calibra Abutment Resin CementDentsply Sirona · 2024
- Descendant · 2 generations on · 0 of its ownK230873 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222469 TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · cites it directly3descendants
- K240888Calibra Abutment Resin CementDentsply Sirona · 2024 · cites it directly0descendants
- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K222469TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K222457Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090704 | Multilink Implant | Ivoclar Vivadent, Inc. | 2009 | — |
| 0 (this device) | K130436 | Multilink Hybrid Abutment Cement | Ivoclar Vivadent, AG | 2013 | — |
| +1 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024 | — |
| +2 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +2 | K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +2 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K090704 | Multilink ImplantSummary page 1…202~ Classification Name: Dental Cement (872.3275) (Classification Code EMA) Predicate Devices: Multilink Implant (K090704) Device Description: Multilink® Hybrid Abutment is a self-curing luting composite for the extraoral, permanent cement… | 2009 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K193084 (Southern Implants (Pty), Ltd., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
Extraoral, permanent cementation of ceramic structures made of lithium dislicate glass ceramic (L52) or zirconium oxide on titaniumltitanium alloy or zirconium oxide bases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130436: Multilink Hybrid Abutment Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130436
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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