510(k) · Cleared

Cleared

Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476

K982576510(k) TraditionalCleared Oct 22, 199890-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

Friatec AG · DZE Implant, Endosseous, Root-Form

Cleared on Oct 22, 1998 as substantially equivalent to K874400 (Implant Innovations International, Inc., 1988) after a 90-day review. Its family tree reaches back 1 generation to 1988.

Decided: Oct 22, 1998
Review: 90 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K874400 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK874400 Non-Rotating Gold Cylinder and ScrewImplant Innovations International, Inc. · 1988 · Recalled
This deviceK982576 Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476Friatec AG · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K874400	Non-Rotating Gold Cylinder and Screw	Implant Innovations International, Inc.	1988	1
0 (this device)	K982576	Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476	Friatec AG	1998	—

FIG. 1 — Lineage of K982576, 1988–1998Source: 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 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 K211090 ZENEX Implant Systemscore 25.4 · 15 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
*	K874400	Non-Rotating Gold Cylinder and Screw Summary page 1 …implants Classification Name: Endosseous Implant VIIL.3. Predicate Device Information Name: UCLA abutment Submitter: 3i Implant Innovations Incorporated 510(k) Number: K874400 VIiL.4. Description of the Device The FRIALIT-2® AuroBase abutment is a one part abutment with two working areas, a gold cylind…	Implant Innovations International, Inc.	1988	1

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?

Its one ancestor has a recall.

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

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH RESTORATIONS, CUSTOM ABUTMENTS AND LABORATORY-CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.

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

https://510kreport.com/device/K982576 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982576: Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982576

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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