FDA.reportPublic FDA data

Dima

Primary DI
J01466081678
Brand
Dima
Company
Kulzer GmbH
Model
66081678
Catalog number
66081678
Device description
dima Print Denture Teeth - B1
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZYAdditively manufactured, preformed, resin denture tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172398000DENTCA DENTURE TeethDentca, Inc.2017-11-22PZY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J01466081678PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)431-1785xx@xx.xx

Regulatory Flags#

DUNS number
315666321
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J014660872140Retraxil blue66087214660872142026-04-21
J014660872150Retraxil blue66087215660872152026-04-21
J014661012760Retraxil blue66101276661012762026-04-21
J014661012770Retraxil blue66101277661012772026-04-21
J014661012780Retraxil blue66101278661012782026-04-21
J014660164550Starlight pro66016455660164552026-01-28
J014660573650Starlight pro66057365660573652026-01-28
J014660968300Starlight pro66096830660968302026-01-28
J014660969290Starlight pro66096929660969292026-01-28
J014660971690Starlight pro66097169660971692026-01-28
J014660971700Starlight pro66097170660971702026-01-28
J014661002680VENUS Diamond FLOW66100268661002682024-10-24
J014661002690VENUS Diamond FLOW66100269661002692024-10-24
J014661002700VENUS Diamond FLOW66100270661002702024-10-24
J014661002710VENUS Diamond FLOW66100271661002712024-10-24
J014661002720VENUS Diamond FLOW66100272661002722024-10-24
J014661002730VENUS Diamond FLOW66100273661002732024-10-24
J014661002740VENUS Diamond FLOW66100274661002742024-10-24
J014661002750VENUS Diamond FLOW66100275661002752024-10-24
J014661003060VENUS Diamond FLOW66100306661003062024-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08