Data / Medical devices / United States / Medental Intl.
Medental Intl.: FDA-registered device maker in Vista, CA, United States, 7 510(k) clearances
Medental Intl. is registered with the FDA (registration 1723973) in Vista, CA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 2, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1723973
- FEI number
- 3001236822
- Address
- 3008 Palm Hill DR., Vista, CA, United States, 92084
- Owner or operator
- MEDENTAL INTL. (9030403)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 20, 2008
- Registered through
- 2026
- Brand names listed
- Medental, Medental Pit and Fissure Sealant with Orhothophosphoric Acid (Conditioner), Medental Prophy Paste
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Specification developer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| October 22, 1998 | K983018 | ZINC PHOSPHATE CEMENT | EMA | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| September 30, 1998 | K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | EMA | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| September 14, 1998 | K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| July 31, 1998 | K980990 | POLYCARBOXYLATE CEMENT | EMA | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| December 16, 1997 | K973919 | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) | LBH | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| November 25, 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Dental
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Varnish, Cavity
- All makers of Material, Tooth Shade, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
Updated April 2, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.