Medical device manufacturer
Shofu Dental Corporation
Shofu Dental Corporation holds 97 FDA 510(k) clearances across 16 product codes. Median elapsed review time is 78 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
- 97
- Product codes
- 16
- Median review
- 78 days
- Recall records
- 0
How does FDA spell Shofu Dental Corporation?
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 |
|---|---|---|
| SHOFU DENTAL CORP. | device/registrationlisting | normalised |
| Shofu Dental Corp. | device/510k | normalised |
| Shofu Dental Corporation | 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 Shofu Dental Corporation file in?
16 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 27 | 89 days | |
| EMA | Cement, Dental | 24 | 59 days | |
| EIH | Powder, Porcelain | 15 | 105 days | |
| KLE | Agent, Tooth Bonding, Resin | 13 | 88 days | |
| DZP | Instrument, Diamond, Dental | 4 | 37 days | |
| EJH | Alloy, Metal, Base | 2 | 18 days | |
| ELL | Teeth, Porcelain | 2 | 63 days | |
| ELM | Denture, Plastic, Teeth | 2 | 82 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 84 days | |
| EBD | Coating, Filling Material, Resin | 1 | 240 days | |
| EIE | Dam, Rubber | 1 | 35 days | |
| EJP | Articulators | 1 | 28 days | |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 299 days | |
| EKG | Condenser, Amalgam And Foil, Operative | 1 | 61 days | |
| FHJ | Shield, Circumcision | 1 | 24 days | |
| LBH | Varnish, Cavity | 1 | 217 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 Shofu Dental Corporation 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 Shofu Dental Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252808 | GlasIonomer FX-LC | EMA | 97 | |
| K252165 | ZIRCONOMER P | EMA | 110 | |
| K251470 | ResiCem EX | EMA | 59 | |
| K251578 | BEAUTIFIL II | EBF | 5 | |
| K233161 | BeautiLink SA | EMA | 1 | |
| K222253 | GlasIonomer FX ULTRA | EMA | 57 | |
| K213965 | BeautiBond Xtreme | KLE | 88 | |
| K212939 | Vintage Prime Press | EIH | 184 | |
| K200470 | Shofu Block HC Hard | EBF | 345 | |
| K191794 | Vintage Art Universal | EIH | 92 |
Source: openFDA device/510k · retrieved
Where is Shofu Dental Corporation 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 Shofu Dental Corporation 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.