FDA.reportPublic FDA data

Dentaprint

Primary DI
E235DPTIS0
Brand
Dentaprint
Company
SHOFU DENTAL CORPORATION
Model
DPTI-S
Catalog number
DPTI-S
Device description
DENTAPRINT TRY-IN BW 500g
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235DPTIS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Contacts#

Phone, Email table
PhoneEmail
+1(760) 736-3277customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548162373847AccuMix Ampule MixerE0006E00062026-07-17
E235P08380VINTAGE PRIME PRESSP0838P08382026-07-17
E235P08390VINTAGE PRIME PRESSP0839P08392026-07-17
E235P08580VINTAGE PRIME PRESSP0858P08582026-07-17
E235P08590VINTAGE PRIME PRESSP0859P08592026-07-17
E235P08610VINTAGE PRIME PRESSP0861P08612026-07-17
E235P08620VINTAGE PRIME PRESSP0862P08622026-07-17
E235P08630VINTAGE PRIME PRESSP0863P08632026-07-17
E235P08640VINTAGE PRIME PRESSP0864P08642026-07-17
E235P08650VINTAGE PRIME PRESSP0865P08652026-07-17
E235P08660VINTAGE PRIME PRESSP0866P08662026-07-17
E235P08670VINTAGE PRIME PRESSP0867P08672026-07-17
E235P08680VINTAGE PRIME PRESSP0868P08682026-07-17
E235P08690VINTAGE PRIME PRESSP0869P08692026-07-17
E235P08710VINTAGE PRIME PRESSP0871P08712026-07-17
E235P08720VINTAGE PRIME PRESSP0872P08722026-07-17
E235P08730VINTAGE PRIME PRESSP0873P08732026-07-17
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D0804SCENZ100ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ103ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULW050CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19