510(k) · Cleared

Cleared

Lava Frame, Lava Frame Shade

K072055510(k) TraditionalCleared Feb 26, 2008215-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

3M Espe AG Dental Products · NHA Abutment, Implant, Dental, Endosseous

Cleared on Feb 26, 2008 as substantially equivalent to K032448 (Altatec Biotechnologies, 2003) after a 215-day review. Its family tree reaches back 1 generation to 2003. 176 later devices descend from it.

Decided: Feb 26, 2008
Review: 215 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032448 (2003). 176 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032448 Altatec Ceramic AbutmentAltatec Biotechnologies · 2003
This deviceK072055 Lava Frame, Lava Frame Shade3M Espe AG Dental Products · 2008
Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018

Showing 5 of 176 descendants. See all descendants

Descendants cleared per year

2012high 25 (2023) · low 1 (2012)2026

Most influential descendants

Showing 5 of 176 · See all

K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032448	Altatec Ceramic Abutment	Altatec Biotechnologies	2003	—
0 (this device)	K072055	Lava Frame, Lava Frame Shade	3M Espe AG Dental Products	2008	—
+1	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+2	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—
+2	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+3	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—
+4	K173908	DESS Dental Smart Solutions	Terrats Medical SL	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	2	0
2015	7	0
2016	7	0
2017	9	0
2018	11	0
2019	7	0
2020	14	0
2021	17	0
2022	14	0
2023	25	0
2024	25	0
2025	25	0
2026	11	0

FIG. 1 — Lineage of K072055, 2003–2026Source: 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? (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
*	K032448	Altatec Ceramic Abutment Summary page 1 …............................................... Abutment Predicate Device ALTATEC Camlog Implant System and Abutments by Altatec Biotechnologies ..................... K032448 Traditional 510(k) Lava Frame, Lava Frame Shade 40f112 3M ESPE AG 4 510(k) Summary of Safety and Effectiveness…	Altatec Biotechnologies	2003	—

Also cleared against K032448: 1 other device →

What descends from it? (176)

See all 176

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

Number	Device	Applicant	Decided	Descendants
K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…	Institut Straumann AG	2012	165
K122988	Klockner Dental Implant Abutments	Soadco, S.L.	2013	9

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 no recall.
Of its descendants, K120822 (Institut Straumann AG, 2012) has gone furthest, with 165 descendants of its own.
1 other device also cites its predicate K032448.

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. 2008, 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 Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments. The titanium connection for the abutment must meet the following dimensions: - Overall cementation surface > 30 mm® - Height of the head of the titanium interface from the shoulder > 2.8 mm The…

Read the full statement (201 words)

The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations.

The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments. The titanium connection for the abutment must meet the following dimensions:

- Overall cementation surface > 30 mm®

- Height of the head of the titanium interface from the shoulder > 2.8 mm

The following systems fulfill the above described specifications:

- Co. Alltec Dental GmbH: Camiog Titanium-base for Ceramic-abutment — Abutment @ 2 4.3 mm

- Co. Dentsply Friadent GmbH: Friadent Cera Base

- Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Muiti Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex — Regular Mono Titan; Matrix Abutment Hex — Regular Multi Titan; Matrix Abutment Hex — Narrow Mono Titan; Matrix Abutment Hex — Narrow Multi Titan; Matrix Abutment C-Lect — Regular Mono Titan; Matrix Abutment, C-Lect — Regular Multi Titan; Matrix Abutment C-Lect — Narow Mono Titan; Matrix Abutment C-Lect — Narrow Mono Titan; Matrix Abutment ST — Mono Titan; Matrix Abutment ST ~ Mono Titan

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/K072055 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072055: Lava Frame, Lava Frame Shade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072055

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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