16 results
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115ms
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Sources: EU EUDAMED, US FDA
Dental Studio Venken
Manufacturer
🇧🇪 Belgium
Mayclin Dental Studio
Manufacturer
🇺🇸 United States
Hall Dental Studio Limited
ManufacturerDENTAL STUDIO
FDA registration
DENTAL STUDIO·27 products·🇰🇷 South Korea
MASTER DENTAL STUDIO
FDA registration
MASTER DENTAL STUDIO·10 products·🇺🇸 United States
JAMESB DENTAL STUDIO
FDA registration
JAMESB DENTAL STUDIO·3 products·🇺🇸 United States
PARKSIDE DENTAL STUDIO
FDA registration
PARKSIDE DENTAL STUDIO·2 products·🇺🇸 United States
FIRE DENTAL STUDIO, LLC
FDA registration
FIRE DENTAL STUDIO, LLC·9 products·🇺🇸 United States
RELIABLE DENTAL STUDIO, INC.
FDA registration
RELIABLE DENTAL STUDIO, INC.·9 products·🇺🇸 United States
RELIABLE DENTAL STUDIO, INC.
FDA registration
RELIABLE DENTAL STUDIO, INC.·9 products·🇺🇸 United States
Bayshore Dental Studio LLC
FDA registration
Bayshore Dental Studio LLC·4 products·🇺🇸 United States
GREGORY WEIL DENTAL CERAMIC STUDIO, INC.
FDA registration
GREGORY WEIL DENTAL CERAMIC STUDIO, INC.·3 products·🇺🇸 United States
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 20, 2026
International Associates Auditing & Certification Limited
Authorized representative
🇮🇪 Ireland·46 Manufacturers·161 Devices
Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such.
FDA Recall
Terminated
·Rite-Dent Manufacturing Corp.·Product code EHY·September 21, 2005
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices