FDA product code · Dental
EBFMaterial, Tooth Shade, Resin
Product code EBF covers Material, Tooth Shade, Resin, a Class II device regulated under 21 CFR 872.3690. FDA has cleared 934 devices in this code, 19 of them in the last 12 months. Median review time across the 934 most recent decisions is 69 days. openFDA lists 69 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3690
- Review panel
- Dental
- Clearances
- 934
What is happening in EBF right now?
EBF (Material, Tooth Shade, Resin) has three findings, most consequential first. 3 first-time filers in the last 12 months, including Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. and New Stetic, SA (K260152, K254245, K253053). Clearances are running 30% faster — a median 48 days over the last 12 months against 69 days all-time (elapsed calendar days, not FDA review days) (EBF:review_time:12m). The code is crowded, scoring 94 of 100 — 219 companies hold a clearance here and 19 arrived in the last 12 months (EBF:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260152, K254245, K253053 |
| Review time | Context | EBF:review_time:12m |
| Crowding | Context | EBF:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in EBF?
FDA has cleared 934 devices under product code EBF since the 510(k) programme began in 1976, 19 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | |
| K261246 | SRGC-06 | GC America, Inc. | |
| K261093 | DIAFIL | DiaDent Group International | |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | |
| K260805 | Dual Core | Vericom Co., Ltd. | |
| K261357 | Grandio disc multicolor | Voco GmbH | |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | |
| K260661 | Midas Restore | Sprintray, Inc. |
How long does FDA review take for EBF?
The median FDA review time for EBF is 69 days, measured across the 934 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EBF?
openFDA lists 69 recall records against product code EBF. A recall record covers one firm's corrective action and may span many device lots.
Z-3066-2024Open, ClassifiedUltradent Products, Inc.
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3067-2024Open, ClassifiedUltradent Products, Inc.
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3068-2024Open, ClassifiedUltradent Products, Inc.
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-0053-2021TerminatedUltradent Products, Inc.
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Z-0028-2020TerminatedVoco GmbH
The metal cannula are potentially too loose and may become loose when applying the filing material.
Showing the 5 most recently initiated of 69. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EBF?
MAUDE holds 11 adverse-event reports naming product code EBF.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EBF unusual?
EBF does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
8 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered EBF in the last year?
3 companies filed in EBF for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | K260152 | |
| New Stetic, SA | K254245 | |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | K253053 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in EBF?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EBF?
Across the 934 most recent decisions, these applicants filed most often in EBF.
| Applicant | Recent clearances |
|---|---|
| Voco GmbH | 45 |
| Bisco, Inc. | 30 |
| Scientific Pharmaceuticals, Inc. | 29 |
| Dentsply Intl. | 28 |
| Ivoclar North America, Inc. | 28 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in EBF files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Pulpdent Corporation | 29 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch EBF
Get an email the morning anything changes in EBF — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.