510(k) · Cleared

Cleared

Friadent Estheticap

K050208510(k) TraditionalCleared Jun 14, 2005137-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

Dentsply International · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jun 14, 2005 as substantially equivalent to K974628 (Friatec AG, 1998) and 2 other predicates after a 137-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.

Decided: Jun 14, 2005
Review: 137 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K894595 (1990). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
2 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
1 generation backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
This deviceK050208 Friadent EstheticapDentsply International · 2005
Descendant · cites it directly · 1 of its ownK053099 Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK122559 Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013
Descendant · cites it directly · 0 of its ownK073073 Ankylos Temporary Abutment BalanceDentsply International, Inc. · 2008

Most influential descendants

Showing 3 of 3 · See all

K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc. · 2006 · cites it directly1descendant
K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013 · 2 generations on0descendants
K073073Ankylos Temporary Abutment BalanceDentsply International, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−3	K984104	Iti Dental Implant System	Straumann USA	1999	1
−2	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−1	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
0 (this device)	K050208	Friadent Estheticap	Dentsply International	2005	—
+1	K053099	Biohorizons Plastic Temporary Abutments	BioHorizons Implant Systems, Inc.	2006	—
+2	K122559	Biodenta Dental Implant System - Abutments	Biodenta Swiss AG	2013	—
+1	K073073	Ankylos Temporary Abutment Balance	Dentsply International, Inc.	2008	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2013	1	0

FIG. 1 — Lineage of K050208, 1990–2013Source: 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? (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	Applicant	Decided	Recalls
*	K974628	Frialit-2 Protect Abutment Summary page 1 …Endosseous dental implant abutment (872.3630) PREDICATE DEVICES: ERIADENT® ProTect Abutment cleared under 5 10(k) premarket notification K974628 on March I11, 1998 and K0 13 867 on March 15, 2002 as well as to the Nobel Biocare Temnp Abut Plastic Engaging Select NP cleared…	Friatec AG	1998	—
*	K013867	Xive Dental Implant System Summary page 1 …implant abutment (872.3630) PREDICATE DEVICES: ERIADENT® ProTect Abutment cleared under 5 10(k) premarket notification K974628 on March I11, 1998 and K0 13 867 on March 15, 2002 as well as to the Nobel Biocare Temnp Abut Plastic Engaging Select NP cleared under 5 10(k) premarket notificat…	Friadent GmbH	2002	—
*	K023113	Replace Tiunite Endosseous Implant Summary page 1 …628 on March I11, 1998 and K0 13 867 on March 15, 2002 as well as to the Nobel Biocare Temnp Abut Plastic Engaging Select NP cleared under 5 10(k) premarket notification K023 113 on September 26, 2002 DEVICE DESCRIPTION: The FRIADENT® EsthetiCap abutments create anatomic, esthetic peri-implanit gingival c…	Nobel Biocare Uas, Inc.	2002	27

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K053099	Biohorizons Plastic Temporary Abutments	BioHorizons Implant Systems, Inc.	2006	1
K073073	Ankylos Temporary Abutment Balance	Dentsply International, Inc.	2008	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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
2 of the 13 ancestors have a recall of any class.
Of its descendants, K053099 (BioHorizons Implant Systems, Inc., 2006) has gone furthest, with 1 descendant of its own.

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?

FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges. The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050208 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050208: Friadent Estheticap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050208

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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