510(k) · Cleared

Cleared

Accufit Dental Implant Abutments & Screws

K101068510(k) TraditionalCleared Aug 23, 2010129-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

Radiant Express, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Aug 23, 2010 as substantially equivalent to K061410 (Zimmer Dental, Inc., 2006) and 8 other predicates after a 129-day review. Its family tree reaches back 7 generations to 1990.

Decided: Aug 23, 2010
Review: 129 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 10

Its longest line of descent runs back 7 generations to K894595 (1990). 37 ancestors in all. No later device cites it as a predicate yet.

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 backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
1 generation backK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
This deviceK101068 Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC · 2010

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	K050705	Tiunite Implants	Nobel Biocare AB	2005	1
−1	K061410	Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent…	Zimmer Dental, Inc.	2006	1
0 (this device)	K101068	Accufit Dental Implant Abutments & Screws	Radiant Express, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1994	4	0
1995	1	0
1996	3	0
1997	2	0
1998	1	0
2000	4	0
2001	4	0
2002	4	0
2003	1	0
2004	1	0
2006	1	0
2007	2	0

FIG. 1 — Lineage of K101068, 1990–2010Source: 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

Get a 510(k) Report

What was it cleared against? (10)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K061410	Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… Summary page 3 …e devices' K numbers. Table B: AccuFitTm Preformed Stock Abutments and Predicate Devices' K-numbers Zimmer Tapered Screw-vent Hex-lock K06 1410, abutments & screws KO 11028 Prefomedstock Nobel-Biocare NobelReplace S…	Zimmer Dental, Inc.	2006	1
*	K011028	Screw-Vent Dental Implant System	Sulzer Dental, Inc.	2001	2
*	K021584	Replace Scalloped Margin Implant System Summary page 3 …-vent Hex-lock K06 1410, abutments & screws KO 11028 Prefomedstock Nobel-Biocare NobelReplace Select K02 1584 Same as predicate devices: Preformed, ~Abutments and Screws Aumn-TiaumAl…	Nobel Biocare Uas, Inc.	2002	—
*	K072642	Biomet 3I Dental Abutments and Restorative Components Summary page 3 …ices: Preformed, ~Abutments and Screws Aumn-TiaumAlloy Titanium K072642, Ti6AI4V Abutments & Biomet 3i GingiHue Post & Screw K063403 Screws…	Biomet 3i, Inc.	2007	81
*	K063403	Conical Angled Abutment Summary page 3 …mn-TiaumAlloy Titanium K072642, Ti6AI4V Abutments & Biomet 3i GingiHue Post & Screw K063403 Screws K032774, *Screw - Titanium Alloy…	Implant Innovations, Inc.	2007	5
*	K032774	Renova Internal Hex Implant System Summary page 3 …K072642, Ti6AI4V Abutments & Biomet 3i GingiHue Post & Screw K063403 Screws K032774, *Screw - Titanium Alloy L~ifecor-e Renova & Restore Abutments K965 13 Ti6AI4V…	Lifecore Biomedical, Inc.	2003	—
Kept off the family tree	K096513	Lifecore Renova & Restore Abutments Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K034022	Ucla and Cement-on Abutments and Accessories Summary page 3 …anium Alloy L~ifecor-e Renova & Restore Abutments K965 13 Ti6AI4V K034022 Diamodent Compatible Abutments KO 10619,…	Diamodent	2004	—
*	K010619	Ucla and Universal Abutments	Diamodent	2001	—
*	K993129	Ucla/Universal Abutment Summary page 3 …K034022 Diamodent Compatible Abutments KO 10619, K993 129 _ _ _ _ _ _ _ _ _ _ _ _ _ Whiile some of the predicate devices use sterilized packaging and s…	Diamodent	2000	—

Also cleared against K061410: 12 other devices →

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 20 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
10 of the 37 ancestors have a recall of any class.
12 other devices also cite its predicate K061410.

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. 2010, this device’s year, is highlighted.

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?

AccuFitTM Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla. AccuFitTM Screws are intended for securing a abutment onto an endosseous dental implant. The AccuFitTM Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels…

Read the full statement (142 words)

AccuFitTM Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFitTM Screws are intended for securing a abutment onto an endosseous dental implant.

The AccuFitTM Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

Zimmer Dental — Tapered Screw-vent — 3.5, 4.5, 5.7 mm

Nobel-Biocare — NobelReplace Select — 3.5, 4.3, 5.0 mm

Biomet 3i — Osseotite Certain — 3.4, 4.1, 5.0 mm

Lifecore Biomedical — Renova (internal hex) — 3.5, 4.5 mm

Restore (external hex) — 3.3, 4.1, 5.0 mm

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101068 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101068: Accufit Dental Implant Abutments & Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101068

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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