FDA.reportPublic FDA data

510(k) K011820

Device
DENTORIUM CONVERTIBLE ACRYLIC
Applicant
NATS CORP.
510(k) number
K011820
Product code
EBI  
Decision
Substantially Equivalent (SESE)
Decision date
2001-09-05
Date received
2001-06-11
Regulation
872.3760
Classification name
Resin, Denture, Relining, Repairing, Rebasing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD C LANZILLOTTO
Address
30 Northport Rd. Sound Beach NY US 11789 11789

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.2026-07-31
K262300Denture Base Resin V2Formlabs Ohio, Inc.2026-07-08
K261474DENTCA Tru FlexibleDentca, Inc.2026-07-01
K260569DB 4000 High Impact Denture BaseCarbon, Inc.2026-06-02
K260376Denture BaseShandong Huge Dental Material Corporation2026-05-06
K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.2025-11-25
K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)Graphy, Inc.2025-11-21
K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc.2025-11-20
K252430Freeprint® denture flexDetax GmbH2025-10-30
K252035DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)Kamemizu Chemical Industry Co., Ltd.2025-09-17
K250302Flexible Partial ResinPrismatik Dentalcraft, Inc.2025-06-25
K242897Partial FlexClemde SA DE CV2025-06-03
K250489FP3DKeystone Industries2025-05-20
K250617Apex FlexSprintray, Inc.2025-04-29
K243356Asiga DentaBASEAsiga Pty, Ltd.2025-04-11

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases