510(k) Report

510(k) · Cleared

Cleared

Angled Abutment

K962647510(k) TraditionalCleared Oct 7, 199691-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Straumann USA · DZE Implant, Endosseous, Root-Form

Cleared on Oct 7, 1996 as substantially equivalent to K941393 (The Straumann Co., 1995) and 1 other predicate after a 91-day review. Its family tree reaches back 1 generation to 1992. 176 later devices descend from it.

Decided
Oct 7, 1996
Review
91 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K905434 (1992). 2 ancestors in all. 176 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2000: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2008: 2 descendants cleared2018: 9 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2015: 8 descendants cleared2014: 7 descendants cleared2012: 1 descendant cleared2019: 8 descendants cleared2013: 1 descendant cleared2016: 7 descendants cleared2020: 10 descendants cleared2017: 9 descendants cleared2023: 20 descendants cleared2024: 19 descendants cleared2021: 17 descendants cleared2025: 24 descendants cleared2026: 13 descendants cleared2022: 16 descendants clearedK905434 · Angulated Abutment, Complete,Titanium Sdca 102 · Nobelpharma USA, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 18 descendants5 generations forward: 16 descendants6 generations forward: 33 descendants7 generations forward: 37 descendants8 generations forward: 26 descendants9 generations forward: 12 descendants10 generations forward: 10 descendants11 generations forward: 8 descendants12 generations forward: 2 descendants13 generations forward: 1 descendant K905434 · Angulated Abutment, Complete,Titanium Sdca 102 · Nobelpharma USA, Inc. · 19920+5+10
  1. Root · 1 generation backK905434 Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc. · 1992
  2. This deviceK962647 Angled AbutmentStraumann USA · 1996
  3. Descendant · cites it directly · 175 of its ownK994119 Synocta Angled AbutmentsStraumann USA · 2000
  4. Descendant · 2 generations on · 164 of its ownK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
  5. Descendant · 3 generations on · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
  6. Descendant · 4 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
  7. Descendant · 5 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017

Showing 5 of 176 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12004: 12006: 12007: 12008: 22012: 12013: 12014: 72015: 82016: 72017: 92018: 92019: 82020: 102021: 172022: 162023: 202024: 192025: 242026: 13
2000high 24 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 176 · See all
  • K994119Synocta Angled AbutmentsStraumann USA · 2000 · cites it directly175descendants
  • K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsStraumann Manufacturing, Inc. · 2008 · 2 generations on164descendants
  • K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · 3 generations on115descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 4 generations on89descendants
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 5 generations on86descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905434Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc.1992—
0 (this device)K962647Angled AbutmentStraumann USA1996—
+1K994119Synocta Angled AbutmentsStraumann USA2000—
+2K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004…Straumann Manufacturing, Inc.2008—
+3K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold…Straumann USA, LLC2014—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200410
200610
200710
200820
201210
201310
201470
201580
201670
201790
201890
201980
2020100
2021170
2022160
2023200
2024190
2025240
2026130
FIG. 1 — Lineage of K962647, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DZE? 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 DZE device

  1. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K941393Iti Angled Abutment
Summary page 1
…Name: ITl Angled Abutment Common Name: Abutment for endosseous dental implant Classification Name: Accessory to a dental implant (21 CFR 872.3640) 1. M Angled Abutment (K941393) 2. Branemark Abutment (K905434 3. Calcitek Angled Abutment (K number unknown) 4 3i Angled Abutment (K number unknown) The ITl…
The Straumann Co.1995—
*K905434Angulated Abutment, Complete,Titanium Sdca 102
Summary page 1
…Name: Abutment for endosseous dental implant Classification Name: Accessory to a dental implant (21 CFR 872.3640) 1. M Angled Abutment (K941393) 2. Branemark Abutment (K905434 3. Calcitek Angled Abutment (K number unknown) 4 3i Angled Abutment (K number unknown) The ITl angled abutment is placed into t…
Nobelpharma USA, Inc.1992—
*—Calcitek Angled Abutment
Named without a submission number
—
*—3i Angled Abutment
Named without a submission number
—

What descends from it? (176)

See all 176

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K994119Synocta Angled AbutmentsStraumann USA2000175

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, K994119 (Straumann USA, 2000) has gone furthest, with 175 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result.

The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Straumann USA

41 FDA decisions under this applicant name. See the company

  • K151328PURE Ceramic ImplantsStraumann USA · 2016
  • K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
  • K130724Codiagnostix Implant Planning SoftwareStraumann USA · 2013
  • K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA · 2012
  • K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 20121 recall

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K962647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962647: Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962647

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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