Medical device manufacturer
Ivoclar North America, Inc.
Ivoclar North America, Inc. holds 131 FDA 510(k) clearances across 25 product codes. Median elapsed review time is 52 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 131
- Product codes
- 25
- Median review
- 52 days
- Recall records
- 0
How does FDA spell Ivoclar North America, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Ivoclar North America, Inc. file in?
25 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 29 | 45 days | |
| EBF | Material, Tooth Shade, Resin | 28 | 57 days | |
| EJS | Alloy, Other Noble Metal | 12 | 49 days | |
| EIH | Powder, Porcelain | 10 | 49 days | |
| EMA | Cement, Dental | 9 | 50 days | |
| KLE | Agent, Tooth Bonding, Resin | 5 | 61 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 65 days | |
| EJH | Alloy, Metal, Base | 4 | 26 days | |
| EJJ | Alloy, Amalgam | 4 | 36 days | |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 35 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 78 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 93 days | |
| EFD | Amalgamator, Dental, Ac-Powered | 2 | 56 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 63 days | |
| ELL | Teeth, Porcelain | 2 | 83 days | |
| ELR | Post, Root Canal | 2 | 44 days | |
| LBH | Varnish, Cavity | 2 | 62 days | |
| DZA | Drill, Dental, Intraoral | 1 | 49 days | |
| DZN | Instruments, Dental Hand | 1 | 57 days | |
| EHY | Tray, Impression, Preformed | 1 | 88 days | |
| EJF | Bracket, Metal, Orthodontic | 1 | 50 days | |
| EJP | Articulators | 1 | 42 days | |
| EJW | Clasp, Wire | 1 | 41 days | |
| ELM | Denture, Plastic, Teeth | 1 | 42 days | |
| ELW | Material, Impression | 1 | 168 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 North America, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 North America, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | EIH | 46 | |
| K011491 | HELIOSEAL CLEAR CHROMA | EBC | 93 | |
| K011492 | IN TEN-S | EBF | 51 | |
| K011490 | MODIFICATION TO EXCITE | KLE | 43 | |
| K011023 | D.SIGN 96 | EJT | 28 | |
| K011022 | BIOUNIVERSAL PDF | EJT | 28 | |
| K010381 | D.SIGN 30 | EJH | 26 | |
| K010250 | TETRIC CERAM HB | EBF | 33 | |
| K003293 | EXCITE DSC | KLE | 109 | |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | EMA | 86 |
Source: openFDA device/510k · retrieved
Watch what Ivoclar North America, 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.