Vivadent (USA), Inc.
Mchenry, IL, US
Vivadent (Usa), Inc. appears in FDA device records in Mchenry, IL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Vivadent (USA), Inc. between 1978 and 1986. The busiest year on record is 1980, with 10. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 10 |
| 1981 | 1 |
| 1983 | 1 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K863831 | VIVADENT FILPIN | EBL | Substantially Equivalent | |
| K823409 | HELIOSIT-ORTHODONTIC | DYH | Substantially Equivalent | |
| K813015 | HELIOSEAL | EBC | Substantially Equivalent | |
| K802679 | SILANIT | EBG | Substantially Equivalent | |
| K802684 | HELIOMAT | EAY | Substantially Equivalent | |
| K802683 | HELIOSIT | EBF | Substantially Equivalent | |
| K802682 | CONTACT SEAL | EBC | Substantially Equivalent | |
| K802681 | HELIOBOND | KLE | Substantially Equivalent | |
| K802685 | REOLIT | EJK | Substantially Equivalent | |
| K802680 | ISOPAST-DS | EBF | Substantially Equivalent | |
| K801227 | SILICAP | EMA | Substantially Equivalent | |
| K801229 | BONDALCAP (CARBOXYLATE) | EMA | Substantially Equivalent | |
| K801228 | BONDALCAP (SILICO-PHOSPHATE) | EMA | Substantially Equivalent | |
| K790874 | AMALCAP-NON-GAMMA-2 | EJJ | Substantially Equivalent | |
| K790439 | CONTACT RESIN | EBF | Substantially Equivalent | |
| K790438 | COLORANT | EBD | Substantially Equivalent | |
| K781787 | ISOPLAST | EBF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- EJJAlloy, Amalgam
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- EAYLight, Fiber Optic, Dental
- EJKLiner, Cavity, Calcium Hydroxide
- EBFMaterial, Tooth Shade, Resin
- EBLPin, Retentive And Splinting, And Accessory Instruments
- EBCSealant, Pit And Fissure, And Conditioner
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain