OTC DENTAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3013425656	3013425656	OTC DENTAL	1	N	2026-01-01	3825 W Cheyenne Ave Ste 606 N Las Vegas NV US 89032

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
203171	1855771814	K974865	CSR	EBI	1998-03-16
203171	1543411983

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBI	1	1998-03-16

GUDID#

DenSureFit - DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 4 stick applicators and 1 IFU.The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.

OTC DENTAL CORPORATION

2026-02-26

DenSureFit - DenSureFit (Lower) is an over-the-counter soft reline kit. It consists of 1 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU.The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.

OTC DENTAL CORPORATION

2017-01-23

DenSureFit Pro - DenSureFit Pro is for professional use only. DSF Pro is a chairside denture reline kit utilizing Vinyl Polysiloxane as the reline material. The contents of the kit contains (1) IFU,(1) 50cc cartridge of VPS, (10) mixing tips compatible with 50cc cartridge, (10) medical swabs, (1)15mL vial of Primer, (5) Snug Up At-Home Care kits for home use. The contents of each Snug Up At-Home Care Kit contains (1) 5mL cartridge of VPS, (3) mixing tips compatible with 5mL cartridge, & (1) At-Home IFU.

OTC DENTAL CORPORATION

2025-09-02