Medical device manufacturer
Voco GmbH
Voco GmbH holds 119 FDA 510(k) clearances across 18 product codes. Median elapsed review time is 71 days. openFDA lists 4 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
- 119
- Product codes
- 18
- Median review
- 71 days
- Recall records
- 4
How does FDA spell Voco GmbH?
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 |
|---|---|---|
| VOCO GMBH | device/registrationlisting | normalised |
| Voco GmbH | device/enforcement | normalised |
| Voco GmbH | device/recall | normalised |
| Voco GmbH | 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 Voco GmbH file in?
18 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 45 | 64 days | |
| EMA | Cement, Dental | 26 | 71 days | |
| KLE | Agent, Tooth Bonding, Resin | 10 | 46 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 8 | 71 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 5 | 52 days | |
| EBG | Crown And Bridge, Temporary, Resin | 5 | 35 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 58 days | |
| ELW | Material, Impression | 3 | 50 days | |
| LBH | Varnish, Cavity | 3 | 122 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 108 days | |
| EBD | Coating, Filling Material, Resin | 1 | 74 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 252 days | |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 184 days | |
| EMB | Zinc Oxide Eugenol | 1 | 94 days | |
| KIF | Resin, Root Canal Filling | 1 | 59 days | |
| MQC | Mouthguard, Prescription | 1 | 197 days | |
| MVL | Cord, Retraction | 1 | 73 days | |
| POW | Crown And Bridge, Long-Term Temporary, Resin | 1 | 60 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 Voco GmbH had a recall?
openFDA lists 4 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-1142-2024Class IIOpen, ClassifiedEMA
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-1143-2024Class IIOpen, ClassifiedEMA
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-0028-2020Class IITerminatedEBF
The metal cannula are potentially too loose and may become loose when applying the filing material.
Z-0955-2017Class IITerminatedKLE
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
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 Voco GmbH cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | LBH | 303 | |
| K261357 | Grandio disc multicolor | EBF | 3 | |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | EMA | 214 | |
| K251390 | MTA vpt | KIF | 59 | |
| K251239 | GrandioSO Unlimited | EBF | 29 | |
| K231817 | AlignerFlow LC | DYH | 163 | |
| K231591 | V-Print c&b temp | POW | 60 | |
| K230877 | Admira Fusion 5 | EBF | 105 | |
| K220236 | V-Print dentbase | EBI | 237 | |
| K220640 | Bifix Hybrid Abutment Cement | EMA | 172 |
Source: openFDA device/510k · retrieved
Where is Voco GmbH 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 Voco GmbH files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.