510(k) · Cleared
ClearedInfibra, Model 1200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Dental Products, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Sep 8, 2006 as substantially equivalent to K913040 (Ribbond, Inc., 1991) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 8, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913040 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913040 Ribbond (TM)Ribbond, Inc. · 1991
- This deviceK061735 Infibra, Model 1200Global Dental Products, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913040 | Ribbond (TM) | Ribbond, Inc. | 1991 | — |
| 0 (this device) | K061735 | Infibra, Model 1200 | Global Dental Products, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K913040 | Ribbond (TM)Summary page 1…cal tests were conducted to characterize the material. Predicate device - Substantial Equivalency The modified is substantially equivalent to the previously Ribbond TM (K 913040 date 7 October 1991) and EZ Connect (K 000346) The modified device is substantially equivalent in quality of mechanical character… | 1991 |
| * | K000346 | EZ ConnectSummary page 1…aterial. Predicate device - Substantial Equivalency The modified is substantially equivalent to the previously Ribbond TM (K 913040 date 7 October 1991) and EZ Connect (K 000346) The modified device is substantially equivalent in quality of mechanical characteristics, of mechanical safety, of materials, of… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K913040.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 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?
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications:
As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures. night-guards and orthodontic appliances.
To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges-
To reinforce splints used to immobilize teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061735: Infibra, Model 1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061735
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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