Manufacturer registered with FDA
Medental Intl.
Vista, CA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 6
- 510(k) clearances
- 71997–1999
- Markets registered in
- 311 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Medental Intl. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Medental Intl. | 7 clearances | 1997–1999 | Below |
| Colombia | INVIMA | Manufacturer | MEDENTAL INTL.MEDENTAL INTL | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDENTAL INTL. | 1 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Medental Intl. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Lister | Medental | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Medental | 2008 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | MedentalMedental Pit and Fissure Sealant with Orhothophosphoric Acid (Conditioner) | 2008 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Medental Prophy Paste | 2022 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | Medental | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Medental Intl. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Apr 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | EBF Resin Tooth Shade Material |
| 22 Oct 1998 | K983018 | ZINC PHOSPHATE CEMENT | EMA Dental Cement |
| 30 Sep 1998 | K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | EMA Dental Cement |
| 14 Sep 1998 | K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF Resin Tooth Shade Material |
| 31 Jul 1998 | K980990 | POLYCARBOXYLATE CEMENT | EMA Dental Cement |
| 16 Dec 1997 | K973919 | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) | LBH Cavity Varnish |
| 25 Nov 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC Pit and Fissure Sealant and Conditioner |
Some of these clearances are listed with FDA today by another company: Conamco (7), HEXA Dental (3).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDENTAL INTL.FDA reg. 1723973 | VISTA, CA, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9030403). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.