Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006316962

FEI Number

3006316962

Entity Name

PRAIS RELIABLE DENTAL SUPPLIES S.A

City/State/Country

Victoria Grand Anse Mahe, SC

Establishment Address

310 Premier Building, Albert St, Victoria Grand Anse Mahe -, SC

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Prais Reliable Dental Supplies S.A (Owner Number: 10044581)

Owner / Operator Contact Address

310 Premier Building, Albert St, Victoria, SC-NOTA -, SC

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082744

PMA Number

N/A

All Registered Proprietary Names

BEAUTISEALANT Beautifil Flow Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2018-08-09
EJL	Bur, Dental	Dental	Class 1	872.3240	2026-02-25
EHL	Point, Abrasive	Dental	Class 1	872.6010	2019-10-23
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-08-09
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2025-06-26
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-06-27
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2025-06-26
EJY	Pliers, Operative	Dental	Class 1	872.4565	2025-06-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-08-09
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2022-10-24
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-04-20
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-06-27
ELW	Material, Impression	Dental	Class 2	872.3660	2019-06-27
EFH	Paper, Articulation	Dental	Class 1	872.6140	2022-10-24
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-04-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Prais Reliable Dental Supplies S.A

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006316962. Last updated year: 2026. Please use registration number 3006316962 when referencing this establishment in official correspondence.