510(k) · Cleared

Cleared

SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model 33701, CFB 15 Esthetic Abutment 2MM

K062749510(k) TraditionalCleared Nov 29, 200676-day reviewClass II21 CFR 872.3630

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

Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous

Cleared on Nov 29, 2006 as substantially equivalent to K061003 (Nobel Biocare AB, 2006) after a 76-day review. Its family tree reaches back 7 generations to 1990. 327 later devices descend from it.

Decided: Nov 29, 2006
Review: 76 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K894595 (1990). 21 ancestors in all. 327 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
4 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
3 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
2 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
1 generation backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
This deviceK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
Descendant · cites it directly · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
Descendant · 2 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Descendant · cites it directly · 181 of its ownK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
Descendant · 3 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 4 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015

Showing 5 of 327 descendants. See all descendants

Descendants cleared per year

2007high 41 (2024) · low 2 (2007)2026

Most influential descendants

Showing 5 of 327 · See all

K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · cites it directly278descendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 2 generations on240descendants
K072570Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · cites it directly181descendants
K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 3 generations on165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 4 generations on129descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−6	K984104	Iti Dental Implant System	Straumann USA	1999	1
−5	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−4	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
−3	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
−2	K050258	Groovy Implants	Nobel Biocare AB	2005	28
−1	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
0 (this device)	K062749	SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP…	Nobel Biocare AB	2006	—
+1	K091756	Nobelprocera TI Abutment	Nobel Biocare AB	2009	—
+2	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—
+1	K072570	Nobelactive Multi Unit Abutment	Nobel Biocare AB	2007	1
+3	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+4	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1994	2	0
1996	3	0
1997	2	0
1998	1	0
2002	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	3	0
2009	2	0
2010	4	0
2011	4	0
2012	5	0
2013	6	0
2014	12	0
2015	16	0
2016	17	0
2017	18	0
2018	14	0
2019	17	0
2020	25	0
2021	31	0
2022	25	0
2023	35	0
2024	41	0
2025	32	0
2026	18	0

FIG. 1 — Lineage of K062749, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 30.6 · 19 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K061003	SFB & CFB Implants Summary page 1 …(21 CFR 872.3630) Trade or Proprietary or Model Name: SFB & CFB Angled Abutments Legally Marketed Device(s): SFB & CFB Implants (K061003) Device Description: Nobel Biocare's SFB and CFB angled abutments are artificial tooth abutments designed to fit and function o…	Nobel Biocare AB	2006	—

Also cleared against K061003: 6 other devices →

What descends from it? (327)

See all 327

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091756	Nobelprocera TI Abutment	Nobel Biocare AB	2009	278
K072570	Nobelactive Multi Unit Abutment	Nobel Biocare AB	2007	181
K072129	Nobelactive Zirconia Abutment	Nobel Biocare AB	2008	71
K070533	Bti Endosseous Dental Implant Angled Abutments	B.T.I. Biotechnology Institute, Sl.	2007	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 16 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
4 of the 21 ancestors have a recall of any class.
Of its descendants, K091756 (Nobel Biocare AB, 2009) has gone furthest, with 278 descendants of its own.
6 other devices also cite its predicate K061003.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

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

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)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?

Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB 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/K062749 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062749: SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model 33701, CFB 15 Esthetic Abutment 2MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062749

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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