Medical device manufacturer
Sybron Dental Specialties
Sybron Dental Specialties holds 121 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 65 days. openFDA lists 21 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 121
- Product codes
- 28
- Median review
- 65 days
- Recall records
- 21
How does FDA spell Sybron Dental Specialties?
FDA publishes this company under 4 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 |
|---|---|---|
| Sybron Dental Specialties | device/recall | normalised |
| Sybron Dental Specialties | device/510k | normalised |
| Sybron Dental Specialties | device/enforcement | normalised |
| Sybron Dental Specialties, 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 Sybron Dental Specialties file in?
28 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 28 | 65 days | |
| EMA | Cement, Dental | 14 | 49 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 12 | 62 days | |
| ELW | Material, Impression | 10 | 58 days | |
| KLE | Agent, Tooth Bonding, Resin | 9 | 38 days | |
| EBG | Crown And Bridge, Temporary, Resin | 6 | 60 days | |
| KIF | Resin, Root Canal Filling | 6 | 83 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 | 78 days | |
| EAT | Tester, Pulp | 4 | 39 days | |
| DYW | Bracket, Plastic, Orthodontic | 3 | 72 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 55 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 54 days | |
| EFB | Handpiece, Air-Powered, Dental | 2 | 164 days | |
| EIA | Unit, Operative Dental | 2 | 87 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 76 days | |
| EEF | Clamp, Rubber Dam | 1 | 100 days | |
| EJJ | Alloy, Amalgam | 1 | 72 days | |
| EKS | File, Pulp Canal, Endodontic | 1 | 57 days | |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 82 days | |
| ELB | Scaler, Rotary | 1 | 87 days | |
| ELC | Scaler, Ultrasonic | 1 | 234 days | |
| JEX | Plier, Orthodontic | 1 | 16 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 269 days | |
| KJJ | Cleanser, Root Canal | 1 | 75 days | |
| LQY | Locator, Root Apex | 1 | 82 days |
Showing the 25 they file in most, of 28.
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 Sybron Dental Specialties had a recall?
openFDA lists 21 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1291-2015Class IITerminatedMMP
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
Z-2195-2013Class IITerminatedDYJ
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
Z-0989-2012TerminatedEBF
The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude.
Z-0990-2012TerminatedEBF
The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude.
Z-1146-2012TerminatedELW
Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
Showing the 5 most recently initiated of 21.
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 Sybron Dental Specialties cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K182826 | Ormco Spark Aligner System | NXC | 6 | |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | KCT | 269 | |
| K160097 | Image Fast Set, Image Regular Set | ELW | 199 | |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | 279 | |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | 212 | |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | 190 | |
| K151526 | Zone, ZoneFree, Zone A1 | EMA | 94 | |
| K151332 | Nexus Universal, Nexus Universal Chroma | EMA | 90 | |
| K150559 | Life Fast Set, Life Regular Set | EJK | 105 | |
| K143209 | SonicFill 2 | EBF | 87 |
Source: openFDA device/510k · retrieved
Watch what Sybron Dental Specialties 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.