510(k) · Cleared

Cleared

Provisional Inlay/Onlay Kit

K052800510(k) AbbreviatedCleared Mar 7, 2006155-day reviewClass II21 CFR 872.3770

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

Dmg USA, Inc. · EBG Crown And Bridge, Temporary, Resin

Cleared on Mar 7, 2006 as substantially equivalent to K042820 (Ivoclar Vivadent, Inc., 2004) and 6 other predicates after a 155-day review. Its family tree reaches back 2 generations to 1999.

Decided: Mar 7, 2006
Review: 155 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K992097 (1999). 8 ancestors in all, the oldest K926418 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK992097 EndorezUltradent Products, Inc. · 1999
1 generation backK011748 First Fill R.C.S.Jeneric/Pentron, Inc. · 2001
This deviceK052800 Provisional Inlay/Onlay KitDmg USA, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K992097	Endorez	Ultradent Products, Inc.	1999	—
−1	K011748	First Fill R.C.S.	Jeneric/Pentron, Inc.	2001	—
0 (this device)	K052800	Provisional Inlay/Onlay Kit	Dmg USA, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	3	0
2002	1	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K052800, 1999–2006Source: 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 EBG? 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 EBG device

#1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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? (7)

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
*	K042820	Systemp.C&B Plus Summary page 1 …llowing: Table J.1: Substantial E ulvalence- Provisional Inlay/Onlay Product Name 510(k # Manufacturer Systemp.C&B Plus K042820 Ivoclar Vivadent, Inc. Termhase K020092 Kerr Dental Fermit N Lightcuring K934978…	Ivoclar Vivadent, Inc.	2004	—
*	K020092	Temphase Summary page 1 …ay/Onlay Product Name 510(k # Manufacturer Systemp.C&B Plus K042820 Ivoclar Vivadent, Inc. Termhase K020092 Kerr Dental Fermit N Lightcuring K934978 Ivoclar North America, Temporary Filling…	Kerr Dental Materials Center	2002	—
*	K934978	Fermit N Light-Curing Temporary Filling Material Summary page 1 …ufacturer Systemp.C&B Plus K042820 Ivoclar Vivadent, Inc. Termhase K020092 Kerr Dental Fermit N Lightcuring K934978 Ivoclar North America, Temporary Filling Inc. Material Clip…	Ivoclar North America, Inc.	1993	—
*	K926418	CLIP Summary page 1 …Fermit N Lightcuring K934978 Ivoclar North America, Temporary Filling Inc. Material Clip K926418 Voco GmbH Tempit K931084 Centrix, Inc. First Fill R.C.S. K011748 Jeneric/…	Voco GmbH	1993	—
*	K931084	Tempit Summary page 1 …th America, Temporary Filling Inc. Material Clip K926418 Voco GmbH Tempit K931084 Centrix, Inc. First Fill R.C.S. K011748 Jeneric/ Pentron, Inc. The FitInspector material is substantial…	Centrix, Inc.	1993	—
*	K011748	First Fill R.C.S. Summary page 1 …c. Material Clip K926418 Voco GmbH Tempit K931084 Centrix, Inc. First Fill R.C.S. K011748 Jeneric/ Pentron, Inc. The FitInspector material is substantially equivalent to the following impression material:…	Jeneric/Pentron, Inc.	2001	—
*	K032289	Fit Checker II Summary page 1 …ssion material: Table J. 2: Substantial Equivalence - FitInspector Product Name 510(k # Manufacturer Fit Checker II K032289 GC America, Inc. Product Descriptionlindications for Use: The Provisional Inlay and Onlay materials are light-curing compo…	GC America, Inc.	2003	—

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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
None of the 8 ancestors has a recall.

How does its category compare?

All EBG devices

EBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBG

4in 2025

2007high 14 (2020) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBG

106in 2025

2007high 265 (2021) · low 64 (2007)2026

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

Recalls per year · EBG

1in 2020

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EBG

1in 2025

2007high 26 (2015) · low 0 (2018)2025

MAUDE reports naming product code EBG, 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	3	64	0	4
2008	9	83	0	4
2009	2	—	1	1
2010	5	103	0	1
2011	10	96	0	1
2012	5	90	0	5
2013	2	—	0	11
2014	3	114	0	23
2015	6	209	0	26
2016	4	163	0	8
2017	2	—	0	4
2018	4	202	0	0
2019	6	98	0	6
2020	14	194	1	2
2021	3	265	0	4
2022	3	73	0	2
2023	2	—	0	0
2024	5	144	0	0
2025	4	106	0	1
2026	2	—	0	—

What is it indicated for?

The provisional inlay and onlay materials are light-curing composites for:

* temporary care of inlay and onlay preparations

* temporary obturation of implant screw access canals

* relining material for prefabricated crowns

* temporary (light cured) cement

* individualization of splints

* forming aids for matrices

* bite registration

FitInspector is an addition-curing silicone for:

* control of precision of fit, marginal adaption and marginal gaps of:

- inlays / onlays;

- crowns and bridges;

- cast metal cores, crowns;

- metal denture bases; and

* provisional cement for inlays, onlays, crowns and bridges

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052800 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052800: Provisional Inlay/Onlay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052800

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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