Medical device manufacturer
Ivoclar Vivadent, Inc.
Ivoclar Vivadent, Inc. holds 97 FDA 510(k) clearances across 19 product codes. Median elapsed review time is 87 days. openFDA lists 44 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 97
- Product codes
- 19
- Median review
- 87 days
- Recall records
- 44
How does FDA spell Ivoclar Vivadent, Inc.?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| IVOCLAR VIVADENT AG | device/recall | normalised |
| IVOCLAR VIVADENT AG | device/enforcement | normalised |
| IVOCLAR VIVADENT AG | device/registrationlisting | normalised |
| IVOCLAR VIVADENT, INC. | device/registrationlisting | normalised |
| Ivoclar Vivadent AG | device/enforcement | normalised |
| Ivoclar Vivadent AG | device/recall | normalised |
| Ivoclar Vivadent GmbH | device/registrationlisting | normalised |
| Ivoclar Vivadent, AG | device/510k | normalised |
Showing 8 of 11.
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Ivoclar Vivadent, Inc. file in?
19 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 17 | 87 days | |
| KLE | Agent, Tooth Bonding, Resin | 10 | 90 days | |
| EIH | Powder, Porcelain | 9 | 111 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 8 | 64 days | |
| EJT | Alloy, Gold-Based Noble Metal | 7 | 47 days | |
| EMA | Cement, Dental | 7 | 71 days | |
| EBG | Crown And Bridge, Temporary, Resin | 6 | 89 days | |
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 107 days | |
| ELM | Denture, Plastic, Teeth | 5 | 81 days | |
| EJS | Alloy, Other Noble Metal | 4 | 77 days | |
| LBH | Varnish, Cavity | 4 | 207 days | |
| EJH | Alloy, Metal, Base | 3 | 64 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 67 days | |
| ELR | Post, Root Canal | 2 | 38 days | |
| ELW | Material, Impression | 2 | 107 days | |
| GEX | Powered Laser Surgical Instrument | 2 | 94 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 165 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 63 days | |
| PEM | Dental Barriers And Sleeves | 1 | 130 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Ivoclar Vivadent, Inc. had a recall?
openFDA lists 44 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1703-2024Class IIOpen, ClassifiedEIH
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1704-2024Class IIOpen, ClassifiedEIH
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1705-2024Class IIOpen, ClassifiedEIH
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1706-2024Class IIOpen, ClassifiedEIH
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1707-2024Class IIOpen, ClassifiedEIH
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Showing the 5 most recently initiated of 44.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Ivoclar Vivadent, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | EBF | 57 | |
| K253953 | IPS e.max Zirconia | EIH | 90 | |
| K252450 | Adhese 2 | KLE | 213 | |
| K233995 | Ivotion Base Print | EBI | 67 | |
| K210804 | Adhese Universal DC, Cention Primer | KLE | 447 | |
| K211916 | IPS e.max One | EIH | 60 | |
| K193193 | Telio CAD Abutment Solutions- extra systems | NHA | 363 | |
| K191453 | Cervitec F | LBH | 256 | |
| K191448 | Barrier Sleeves | PEM | 130 | |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | NHA | 95 |
Source: openFDA device/510k · retrieved
Where is Ivoclar Vivadent, Inc. registered?
FDA lists 5 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Ivoclar Vivadent, Inc. files next
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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.