510(k) · Cleared
ClearedNobelprocera Angulated Screw Channel Abutment Replace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 4, 2014 as substantially equivalent to K031719 (Nobel Biocare AB, 2003) after a 151-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Apr 4, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913255 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK913255 Ceramic (TM) AbutmentCeramic Core Corp. · 1994
- 1 generation backK031719 Esthetic Zirconia AbutmentNobel Biocare AB · 2003
- This deviceK133377 Nobelprocera Angulated Screw Channel Abutment ReplaceNobel Biocare AB · 2014
- Descendant · cites it directly · 0 of its ownK151439 Atlantis IsusDentsply International, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K151439Atlantis IsusDentsply International, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913255 | Ceramic (TM) Abutment | Ceramic Core Corp. | 1994 | — |
| −1 | K031719 | Esthetic Zirconia Abutment | Nobel Biocare AB | 2003 | — |
| 0 (this device) | K133377 | Nobelprocera Angulated Screw Channel Abutment Replace | Nobel Biocare AB | 2014 | — |
| +1 | K151439 | Atlantis Isus | Dentsply International, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K031719 | Esthetic Zirconia AbutmentSummary page 1…r Model Name: NobelProcera Angulated Screw Channel Abutment Replace Legally Marketed Devices: Nobel Biocare - Esthetic Zirconia Abutment (K031719) Device Description: Nobel Biocare's NobelProcera Angulated Screw Channel Abutment Replace is an endosseous dental implant abut… | 2003 |
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 |
|---|---|---|---|
| K151439 | Atlantis Isus | 2016 | 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 20 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151439 (Dentsply International, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K031719.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133377: Nobelprocera Angulated Screw Channel Abutment Replace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133377
Report an extraction error
Are you the manufacturer?
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