Medical device manufacturer
Institut Straumann AG
Institut Straumann AG holds 92 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 134 days. openFDA lists no recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 92
- Product codes
- 12
- Median review
- 134 days
- Recall records
- 0
How does FDA spell Institut Straumann AG?
FDA publishes this company under 3 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 |
|---|---|---|
| INSTITUT STRAUMANN AG | device/registrationlisting | normalised |
| Institut Straumann AG | device/510k | normalised |
| Institut Straumann SA | device/510k | normalised |
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 Institut Straumann AG file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 47 | 112 days | |
| DZE | Implant, Endosseous, Root-Form | 31 | 167 days | |
| EIH | Powder, Porcelain | 3 | 17 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 90 days | |
| JEY | Plate, Bone | 1 | 83 days | |
| KJJ | Cleanser, Root Canal | 1 | 201 days | |
| LYC | Bone Grafting Material, Synthetic | 1 | 156 days | |
| NPK | Barrier, Synthetic, Intraoral | 1 | 298 days | |
| NPL | Barrier, Animal Source, Intraoral | 1 | 234 days | |
| NPM | Bone Grafting Material, Animal Source | 1 | 332 days | |
| OAT | Implant, Endosseous, Orthodontic | 1 | 25 days | |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 | 455 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 Institut Straumann AG 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 Institut Straumann AG cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | KCT | 90 | |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | NHA | 85 | |
| K252168 | Straumann® BLC Implants - Indication Widening | DZE | 243 | |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA | 114 | |
| K250294 | Straumann® RidgeFit Implants | DZE | 193 | |
| K243278 | Custom Abutments | NHA | 128 | |
| K243478 | Straumann InLab Validated Workflow | NHA | 103 | |
| K233252 | Straumann CARES Visual and Nova Dental CAD | PNP | 455 | |
| K241391 | Straumann® PURE Ceramic Implants | DZE | 209 | |
| K234049 | Straumann® BLC and TLC Implants - Line extension | DZE | 90 |
Source: openFDA device/510k · retrieved
Where is Institut Straumann AG registered?
FDA lists 1 registered establishment 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 Institut Straumann AG 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.