FDA.reportPublic FDA data

DENTCA Denture Teeth

Primary DI
00856551007322
Brand
DENTCA Denture Teeth
Company
DENTCA, INC.
Model
DENTCA Denture Teeth
Device description
DENTCA Denture Teeth - A3 - 1kg
Published
2017-07-07
Public version status
Update
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
00856551007322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856551007322008565510073228565510073220856551007322

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place. Do not expose to direct sunlight.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(424)558-8726info@dentca.com

Regulatory Flags#

DUNS number
022455143
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856551007520DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007537DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007544DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007551DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007568DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007575DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007582DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007599DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007605Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007612Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007629Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007636Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007704Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007711Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007728Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007735Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007742Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007759Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007766Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007001DENTCA Try-inDENTCA Denture Base II2019-03-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
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
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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