FDA.reportPublic FDA data

Vintage MP Press Over

Primary DI
E23596460
Brand
Vintage MP Press Over
Company
SHOFU DENTAL CORPORATION
Model
9646
Catalog number
9646
Device description
VINTAGE MP PRESS OVER A3
Published
2016-09-23
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122614000VINTAGE MP PRESS OVERShofu Dental Corporation2013-05-16EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23596460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-566-3528ckaemmerlen@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
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