Medical device manufacturer
Dentsply Intl., Inc.
Dentsply Intl., Inc. holds 291 FDA 510(k) clearances across 69 product codes. Median elapsed review time is 55 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 291
- Product codes
- 69
- Median review
- 55 days
- Recall records
- 0
How does FDA spell Dentsply Intl., Inc.?
FDA publishes this company under 2 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 |
|---|---|---|
| Dentsply Intl. | device/510k | normalised |
| Dentsply Intl., Inc. | 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 Dentsply Intl., Inc. file in?
69 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 28 | 41 days | |
| EIH | Powder, Porcelain | 23 | 39 days | |
| KLE | Agent, Tooth Bonding, Resin | 20 | 44 days | |
| EMA | Cement, Dental | 19 | 79 days | |
| ELW | Material, Impression | 18 | 52 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 16 | 49 days | |
| ELC | Scaler, Ultrasonic | 13 | 84 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 11 | 64 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 8 | 45 days | |
| EFB | Handpiece, Air-Powered, Dental | 8 | 83 days | |
| LBH | Varnish, Cavity | 6 | 84 days | |
| EBH | Material, Impression Tray, Resin | 5 | 65 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 5 | 47 days | |
| EJH | Alloy, Metal, Base | 5 | 41 days | |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 5 | 73 days | |
| ELL | Teeth, Porcelain | 5 | 35 days | |
| KIF | Resin, Root Canal Filling | 5 | 55 days | |
| EHD | Unit, X-Ray, Extraoral With Timer | 4 | 34 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 56 days | |
| EJT | Alloy, Gold-Based Noble Metal | 4 | 64 days | |
| ELM | Denture, Plastic, Teeth | 4 | 33 days | |
| KJJ | Cleanser, Root Canal | 4 | 35 days | |
| DZE | Implant, Endosseous, Root-Form | 3 | 151 days | |
| EFS | Unit, Oral Irrigation | 3 | 70 days | |
| EIA | Unit, Operative Dental | 3 | 38 days |
Showing the 25 they file in most, of 69.
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 Dentsply Intl., 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 Dentsply Intl., Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K140347 | ANKYLOS C/X IMPLANT SYSTEM | DZE | 190 | |
| K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | ELC | 117 | |
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | EIH | 91 | |
| K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | KJJ | 104 | |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | DYH | 17 | |
| K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | DZE | 151 | |
| K082198 | DURASHIELD PLUS | LBH | 86 | |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | NHA | 183 | |
| K072989 | AXIS SYSTEM | EFB | 97 | |
| K073117 | DENTIN DESENSITIZER AGENT | LBH | 44 |
Source: openFDA device/510k · retrieved
Watch what Dentsply Intl., 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.