Registered with FDA
Prais Reliable Dental Supplies S.A
Victoria, Seychelles. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Seychelles
Devices listed with FDA
What Prais Reliable Dental Supplies S.A currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Beautifil Flow PlusHerculite EnamelHerculite SyringeHerculite Unidose | 2013 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2019 |
| Dental CementEMA · Class 2 | Dental cements | Lister | MAXCEM 2 | 2013 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2019 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | BEAUTISEALANT | 2018 |
| Articulation PaperEFH · Class 1 | — | Lister | — | 2022 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | — | 2020 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | — | 2019 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | — | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | — | 2026 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Preformed CrownELZ · Class 1 | — | Lister | — | 2025 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2 | — | Lister | MAXCEM 2 | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Prais Reliable Dental Supplies S.A lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sybron Dental Specialties (5), Shofu Inc (5), Swiss American Metal Craft Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 May 2013 | K130869 | TAKE 1 ADVANCE | Sybron Dental Specialties | ELW Impression Material |
| 16 Sep 2011 | K111782 | BEAUTISEALANT | Shofu Inc | EBC Pit and Fissure Sealant and Conditioner |
| 5 Apr 2011 | K110378 | IMPRESSION COMPOUND | Sybron Dental Specialties | ELW Impression Material |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 11 Dec 2008 | K082744 | BEAUTIBOND | Shofu Inc | KLE Resin Tooth Bonding Agent |
| 29 Jan 2008 | K073209 | MAXCEM 2 | Sybron Dental Specialties | MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 18 Jan 2002 | K013510 | POINT 4 MODIFIED | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 9 Jul 1999 | K991808 | OPTIBOND SOLO PLUS 2 | Sybron Dental Specialties | KLE Resin Tooth Bonding Agent |
| 24 Aug 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | Shofu Inc | EMA Dental Cement |
| 30 Dec 1980 | K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | EJL Dental Bur |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRAIS RELIABLE DENTAL SUPPLIES S.AFDA reg. 3006316962 | Victoria Grand Anse Mahe, Seychelles | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044581). 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.