Data / Medical devices / Seychelles / Prais Reliable Dental Supplies S.A
Prais Reliable Dental Supplies S.A: FDA-registered device maker in Victoria Grand Anse Mahe, Seychelles, 11 510(k) clearances
Prais Reliable Dental Supplies S.A is registered with the FDA (registration 3006316962) in Victoria Grand Anse Mahe, Seychelles. It lists 15 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 30, 2013. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006316962
- Address
- 310 Premier Building, Albert St, Victoria Grand Anse Mahe, Seychelles, -
- Owner or operator
- Prais Reliable Dental Supplies S.A (10044581)
- Roles
- Exporter to the US
- First device listed
- June 28, 2013
- Registered through
- 2027
- Brand names listed
- BEAUTISEALANT, Beautifil Flow Plus, Herculite Enamel, Herculite Syringe, Herculite Unidose, MAXCEM 2
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 30, 2013 | K130869 | TAKE 1 ADVANCE | ELW | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| September 16, 2011 | K111782 | BEAUTISEALANT | EBC | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| April 5, 2011 | K110378 | IMPRESSION COMPOUND | ELW | Substantially Equivalent | Spofadental | accessdata.fda.gov |
| August 23, 2010 | K101603 | BEAUTIFIL FLOW PLUS | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| December 11, 2008 | K082744 | BEAUTIBOND | KLE | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| January 29, 2008 | K073209 | MAXCEM 2 | MZW | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| August 15, 2007 | K071742 | BEAUTIFIL II | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| January 18, 2002 | K013510 | POINT 4 MODIFIED | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| July 9, 1999 | K991808 | OPTIBOND SOLO PLUS 2 | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| August 24, 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| December 30, 1980 | K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | EJL | Substantially Equivalent | Swiss American Metal Craft Corp. | accessdata.fda.gov |
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Updated May 30, 2013. 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.