510(k) · Cleared

Cleared

Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders

K034024510(k) TraditionalCleared Mar 19, 200481-day reviewClass II21 CFR 872.3760

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

Bisco, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Mar 19, 2004 as substantially equivalent to K013881 (Ribbond, Inc., 2002) after an 81-day review. Its family tree reaches back 2 generations to 1991.

Decided: Mar 19, 2004
Review: 81 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K913040 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK913040 Ribbond (TM)Ribbond, Inc. · 1991
1 generation backK013881 Ribbond - TriaxialRibbond, Inc. · 2002
This deviceK034024 Tescera Fiber Bundles, Fiber Mesh and Fiber CylindersBisco, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K913040	Ribbond (TM)	Ribbond, Inc.	1991	—
−1	K013881	Ribbond - Triaxial	Ribbond, Inc.	2002	—
0 (this device)	K034024	Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders	Bisco, Inc.	2004	—

FIG. 1 — Lineage of K034024, 1991–2004Source: 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 EBI? 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 EBI device

#1 K250617 Apex Flexscore 18.3 · 1 generation · 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
*	K013881	Ribbond - Triaxial Summary page 1 …Classification/Name: Class ii per 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin 3. Predicate Device: Ribbond-Triaxial from Ribbond, Inc, cleared under K013881 dated 01/25/2002 4. Description of Application Device: TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are glass fib…	Ribbond, Inc.	2002	—

Also cleared against K013881: 1 other device →

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 13 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K013881.

How does its category compare?

All EBI devices

EBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBI

11in 2025

2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007high 283 (2020) · low 53 (2007)2026

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

Recalls per year · EBI

2in 2022

2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · EBI

34in 2025

2007high 34 (2025) · low 1 (2024)2025

MAUDE reports naming product code EBI, 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	10	53	0	7
2008	6	124	0	2
2009	3	234	0	5
2010	4	95	0	4
2011	11	113	0	6
2012	3	85	0	9
2013	5	135	0	5
2014	5	102	0	9
2015	9	106	0	8
2016	7	147	0	9
2017	8	196	0	2
2018	5	158	2	2
2019	4	127	0	10
2020	6	283	0	8
2021	4	99	0	25
2022	11	154	2	2
2023	11	96	0	13
2024	9	90	0	1
2025	11	79	0	34
2026	7	87	0	—

What is it indicated for?

As reinforcement for:

1. Removable dentures

2. Crown and bridge (Composite)

a. single units

b. multiple unit bridges

c. inlay bridges

d. Maryland Bridges

3. Provisional Crown and Bridge

a. single units

b. inlay bridges

c. multiple unit bridges

d. Maryland Bridges

4. Splint device reinforcement (Bruxism Appliance)

5. Splinting of teeth

6. Orthodontic Appliances

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K034024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K034024: Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K034024

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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