510(k) · Cleared
ClearedJet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, Metr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.B.C and Co. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Feb 24, 1998 after a 68-day review. The FDA summary names no predicate by number.
- Decided
- Feb 24, 1998
- Review
- 68 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances. 1. Orthodontic and Dental laboratories: a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances. b. trained in the proper use, precautions and hazards of dental resins c. the actual fabrication of these dental devices must first be preceded by…
Read the full statement (135 words)
Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances.
1. Orthodontic and Dental laboratories:
a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances.
b. trained in the proper use, precautions and hazards of dental resins
c. the actual fabrication of these dental devices must first be preceded by an authorized prescription for such a device, by a licensed dental practitioner.
2. Dental Offices/Clinics
a. to be used by qualified dentists/dental assistants trained in the fabrication of orthodontic, pedodontic fixed and removable appliances.
b. to be used by qualified dentists/dental assistants trained in the proper use, precautions and hazards of dental resins
c. to be used under the direct supervision of a licensed dental practitioner
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/K974727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974727: Jet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, Metr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974727
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026