510(k) · Cleared
ClearedIntra-Lock International Angled Prosthetic Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra-Lock International · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 22, 2004 as substantially equivalent to K994119 (Straumann USA, 2000) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Mar 22, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K905434 (1992). 9 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK905434 Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc. · 1992
- 2 generations backK962647 Angled AbutmentStraumann USA · 1996
- 1 generation backK994119 Synocta Angled AbutmentsStraumann USA · 2000
- This deviceK040205 Intra-Lock International Angled Prosthetic AbutmentsIntra-Lock International · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905434 | Angulated Abutment, Complete,Titanium Sdca 102 | Nobelpharma USA, Inc. | 1992 | — |
| −2 | K962647 | Angled Abutment | Straumann USA | 1996 | — |
| −1 | K994119 | Synocta Angled Abutments | Straumann USA | 2000 | — |
| 0 (this device) | K040205 | Intra-Lock International Angled Prosthetic Abutments | Intra-Lock International | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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 |
|---|---|---|---|
| * | K994119 | Synocta Angled AbutmentsSummary page 1…Cosmetic Act, the device classification is Class Ill. Predicate Devices: Straumann USA, Angled Abutments K994119 Opti-Max Angled Crown Post K972769 Implant Innovatio… | 2000 |
| * | K972769 | Opti-Max Angled Crown Post for Externally-Hexed Implants, in 15 Degree and 25 Degree…Summary page 1…ces: Straumann USA, Angled Abutments K994119 Opti-Max Angled Crown Post K972769 Implant Innovations, Pre-Angled Abutments K932123 Product Description: The Intra-Lock Int… | 1997 |
| * | K932123 | Implant Innovation Pre-Angled Abutment SystemSummary page 1…94119 Opti-Max Angled Crown Post K972769 Implant Innovations, Pre-Angled Abutments K932123 Product Description: The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous D… | 1994 |
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 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
- 4 other devices also cite its predicate K994119.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth bridge applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040205 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040205: Intra-Lock International Angled Prosthetic Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040205
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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