510(k) · Cleared

Cleared

Ora 0.4MM [S], Ora 1.0MM [S], Ora 2.0MM [S], Ora 3.0MM [S], Ora 4.0MM [S]

K133791510(k) AbbreviatedCleared Apr 16, 2014124-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

Sterngold Dental, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Apr 16, 2014 as substantially equivalent to K900099 (Attachments Intl., Inc., 1991) and 2 other predicates after a 124-day review. Its family tree reaches back 4 generations to 2010.

Decided: Apr 16, 2014
Review: 124 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K083876 (2010). 5 ancestors in all, the oldest K900099 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK083876 Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA · 2010
3 generations backK102382 Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss…Cendres & Metaux SA · 2010
2 generations backK130183 Sfi Bar AbutmentsSterngold Dental, LLC · 2013
1 generation backK132814 Sfi-Bar Implant AbutmentsSterngold Dental, LLC · 2014
This deviceK133791 Ora 0.4MM [S], Ora 1.0MM [S], Ora 2.0MM [S], Ora 3.0MM [S], Ora…Sterngold Dental, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K083876	Sfi-Bar System Complete 2-Implant and 4-Implant	Cendres & Metaux SA	2010	—
−3	K102382	Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant	Cendres & Metaux SA	2010	—
−2	K130183	Sfi Bar Abutments	Sterngold Dental, LLC	2013	—
−1	K132814	Sfi-Bar Implant Abutments	Sterngold Dental, LLC	2014	—
0 (this device)	K133791	Ora 0.4MM [S], Ora 1.0MM [S], Ora 2.0MM [S], Ora 3.0MM [S], Ora 4.0MM [S]	Sterngold Dental, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K133791, 2010–2014Source: 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
*	K900099	The O-Ring System - Ors Summary page 1 …ication is Class 11 Product Code: NHA (21CFR 872.3630) Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K900099, K1301 83, K1 32814. K900099 The 0-Ring System - ORS K1301 83 SF1 Bar® Implant Abutments for 7 Platforms K1…	Attachments Intl., Inc.	1991	—
*	K130183	Sfi Bar Abutments Summary page 1 …s Class 11 Product Code: NHA (21CFR 872.3630) Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K900099, K1301 83, K1 32814. K900099 The 0-Ring System - ORS K1301 83 SF1 Bar® Implant Abutments for 7 Platforms K132814…	Sterngold Dental, LLC	2013	—
*	K132814	Sfi-Bar Implant Abutments Cleared while this submission was under review Summary page 1 …Product Code: NHA (21CFR 872.3630) Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K900099, K1301 83, K1 32814. K900099 The 0-Ring System - ORS K1301 83 SF1 Bar® Implant Abutments for 7 Platforms K132814 SF1…	Sterngold Dental, LLC	2014	—

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 4 years and passes through 2 companies; a new generation was cleared every 9 months on median.
None of the 5 ancestors has a recall.

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. 2014, 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?

The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SF1 Abutments which are screwed into endosseous implants.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133791 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133791: Ora 0.4MM [S], Ora 1.0MM [S], Ora 2.0MM [S], Ora 3.0MM [S], Ora 4.0MM [S].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133791

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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