Medical device manufacturer
Pulpdent Corporation
Pulpdent Corporation holds 110 FDA 510(k) clearances across 21 product codes. Median elapsed review time is 77 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
- 110
- Product codes
- 21
- Median review
- 77 days
- Recall records
- 0
How does FDA spell Pulpdent 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 |
|---|---|---|
| PULPDENT CORPORATION | device/registrationlisting | normalised |
| Pulpdent Corp. | device/510k | normalised |
| Pulpdent 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 Pulpdent Corporation file in?
21 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 29 | 82 days | |
| EMA | Cement, Dental | 14 | 56 days | |
| KLE | Agent, Tooth Bonding, Resin | 11 | 79 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 10 | 77 days | |
| LBH | Varnish, Cavity | 10 | 81 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 9 | 79 days | |
| KIF | Resin, Root Canal Filling | 6 | 82 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 54 days | |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 3 | 82 days | |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 83 days | |
| EKJ | Burnisher, Operative | 2 | 57 days | |
| EBD | Coating, Filling Material, Resin | 1 | 45 days | |
| EIE | Dam, Rubber | 1 | 58 days | |
| EKL | Point, Silver, Endodontic | 1 | 35 days | |
| EKM | Gutta-Percha | 1 | 82 days | |
| ELL | Teeth, Porcelain | 1 | 92 days | |
| EME | Punch, Biopsy, Surgical | 1 | 204 days | |
| KJJ | Cleanser, Root Canal | 1 | 22 days | |
| LFC | Device, Caries Detection | 1 | 73 days | |
| LQY | Locator, Root Apex | 1 | 53 days | |
| ONK | Oral Lubricant | 1 | 87 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 Pulpdent 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 Pulpdent Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K210045 | ACTIVA PRESTO PACK | EBF | 257 | |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | DYH | 111 | |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | EBC | 171 | |
| K153249 | Pulpdent Solo Flowable Composite with MCP | EBF | 144 | |
| K130223 | RMGI FILL | EMA | 59 | |
| K123265 | RMGI LOW VISCOSITY | EMA | 49 | |
| K120784 | TUFF-TEMP 2.0 | EBG | 85 | |
| K120003 | NUCAL | EJK | 93 | |
| K120213 | ETCH-RITE SUPREME | KLE | 66 | |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | EBC | 85 |
Source: openFDA device/510k · retrieved
Where is Pulpdent 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 Pulpdent 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.