FDA.reportPublic FDA data

Digital Denture

Primary DI
00810002220128
Brand
Digital Denture
Company
JOHN'S DENTAL LABORATORY INC
Model
3014680794
Device description
Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin.
Published
2020-11-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162044000Dentca Denture Base IIDentca, Inc.2017-03-03EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810002220128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810002220128008100022201288100022201280810002220128

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016649253
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810002220104Abutment/Implant30146807942020-11-18
00810002220272Herbst30146807942023-04-05
00810002220258The Silencer30146807942023-04-03
00810002220265NAPA (Nocturnal Airway Patency Appliance)30146807942023-04-03
00810002220241The Luco Hybrid OSA Appliance30146807942023-03-28
00810002220234Vivos mRNA30146807942023-03-28
00810002220166Vivos Dorsal mRNA 30146807942023-02-14
00810002220159Vivos DNA-Lower30146807942022-06-13
00810002220111mmRNA appliance30146807942022-02-04
00810002220012Vivos DNA30146807942020-09-08
00810002220173KeyPrint KeySplint Soft30146807942023-04-04
00810002220098Herbst30146807942020-09-23
00810002220142Vivos mmRNA appliance30146807942023-03-28
00810002220210OASYS (Oral/Nasal Airway System)30146807942023-03-28
00810002220203EMA (Elastic Mandibular Advancement appliance)30146807942023-03-27
00810002220043Silencer30146807942020-09-23
00810002220081NAPA (Nocturnal Airway Patency Appliance)30146807942020-09-23
00810002220050TAP (Thornton Adjustable Positioner)30146807942020-09-23
00810002220067TAP (Thornton Adjustable Positioner) 330146807942020-09-23
00810002220074OASYS (Oral/Nasal Airway System)30146807942020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585827IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29