Medental Intl.
Vista, CA, US
MEDENTAL INTL. appears in FDA device records in Vista, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Medental Intl. between 1997 and 1999. The busiest year on record is 1998, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990314 | MULTI-CURE COMPOSITE CEMENT | EBF | Substantially Equivalent | |
| K983018 | ZINC PHOSPHATE CEMENT | EMA | Substantially Equivalent | |
| K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | EMA | Substantially Equivalent | |
| K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF | Substantially Equivalent | |
| K980990 | POLYCARBOXYLATE CEMENT | EMA | Substantially Equivalent | |
| K973919 | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) | LBH | Substantially Equivalent | |
| K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1723973 | 3001236822 | MEDENTAL INTL. | 3008 PALM HILL DR., VISTA, CA 92084 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain