FDA.reportPublic FDA data

Dentorium

Primary DI
05056079041456
Brand
Dentorium
Company
WRIGHT HEALTH GROUP LIMITED
Model
Convertible CC 1kg Veined
Catalog number
2S05003
Device description
Cold Cure Denture Base Powder
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011820000DENTORIUM CONVERTIBLE ACRYLICNats Corp.2001-09-05EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056079041456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056079041456050560790414565056079041456

GMDN Terms#

Term, Definition table
TermDefinition
Denture base resin kitA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)847-4209mail@dentorium.com

Regulatory Flags#

DUNS number
214045304
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056079069658Dentoluxx VAnterior 133 Upper A2DXV133UA22026-02-18
05056079070036Dentoluxx VAnterior 1H Upper A2DXV1HUA22026-02-18
05056079070043Dentoluxx VAnterior 3M Upper A2DXV3MUA22026-02-18
05056079070050Dentoluxx VAnterior 156 Upper A2DXV156UA22026-02-18
05056079070067Dentoluxx VAnterior 274 Upper A2DXV274UA22026-02-18
05056079070074Dentoluxx VAnterior 23 Lower A2DXV23LA22026-02-18
05056079070081Dentoluxx VAnterior 32 Lower A2DXV32LA22026-02-18
05056079070098Dentoluxx VAnterior PE Upper B1DXVPEUB12026-02-18
05056079070449Dentoluxx VPosterior PE Upper A1DXVPEUA12026-02-18
05056079070456Dentoluxx VPosterior PE Upper A3DXVPEUA32026-02-18
05056079070463Dentoluxx VPosterior PE Upper A3.5DXVPEUA3.52026-02-18
05056079070470Dentoluxx VPosterior PE Upper A4DXVPEUA42026-02-18
05056079070487Dentoluxx VPosterior PE Upper B2DXVPEUB22026-02-18
05056079070494Dentoluxx VPosterior PE Upper B3DXVPEUB32026-02-18
05056079070500Dentoluxx VPosterior PE Upper B4DXVPEUB42026-02-18
05056079070517Dentoluxx VPosterior PE Upper C1DXVPEUC12026-02-18
05056079070524Dentoluxx VPosterior PE Upper C2DXVPEUC22026-02-18
05056079070531Dentoluxx VPosterior PE Upper C3DXVPEUC32026-02-18
05056079070548Dentoluxx VPosterior PE Upper C4DXVPEUC42026-02-18
05056079070555Dentoluxx VPosterior PE Upper D2DXVPEUD22026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
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00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
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