FDA.reportPublic FDA data

Prodent

Primary DI
06970553800003
Brand
Prodent
Company
Prodent Dental Technology (Shenzhen) Co., Ltd.
Model
138972
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
EJHAlloy, Metal, Base

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0202530004 ALL (DW286A)Ivoclar Vivadent, Inc.2002-04-17EJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970553800003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970553800003069705538000036970553800003

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, metal-ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421194088
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970553800010Prodent16012902C2016-08-26
06970553800017Prodent20/40412B2016-08-26
06970553800024Prodent20/40412B2016-08-26
06970553800027ProdentV127072016-08-26
06970553800031Prodent1601272016-08-26
06970553800034Prodent20/40412B2016-08-26
06970553800041Prodent1602203B2016-08-26
06970553800055ProdentN/A2016-09-06
06970553800058Prodent1601272016-08-26
06970553800062ProdentN/A2016-09-06
06970553800065Prodent20/40412C2016-08-26
06970553800072ProdentN/A2016-08-26
06970553800079ProdentN/A2016-09-06
06970553800086ProdentN/A2016-09-06
06970553800089ProdentN/A2016-08-26
06970553800093ProdentN/A2016-08-26
06970553800096ProdentN/A2016-08-26
06970553800102ProdentN/A2016-08-26
06970553800109ProdentN/A2016-09-06
06970553800116ProdentN/A2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760357974917Prime V Disc 98.5 x13.5 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974924Prime V Disc 98.5 x12 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974931Prime V Disc 98.5 x16 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974948Prime V Disc 98.5 x18 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974955Prime V Disc 98.5 x20 mmBERNARD CERVOS SOCIETEEJH2026-06-09
EYET96300010SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET96390120Solibond N Alloy Blank (98,5), 12mm, 1 diskYeti Dentalprodukte GmbHEJH2026-05-11
EYET96900010SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET6050060M0Bite regist. Metal foil wax, brown,SampleYeti Dentalprodukte GmbHEJH2026-04-16
EYET9600100A0Solidur CoCr Partial Denture Alloys 100gYeti Dentalprodukte GmbHEJH2026-04-16
EYET9630001M0Sample SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9690001M0Sample SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9600001M0Sample SOLIDUR CoCr Alloy 30gYeti Dentalprodukte GmbHEJH2026-04-13
EBGO505321Mediloy RPDBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2023-05-12
08050612201229Magnum Vip-AMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202103Magnum Saldatura BMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202110Magnum Saldatura CoMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202455Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
08050612202462Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
J011102403890remanium®DENTAURUM GmbH & Co.KGEJH2019-11-20
07630031703088Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703095Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703101Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703118Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703125Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703132Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703149Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703156Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703163Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703170Base metal alloyInstitut Straumann AGEJH2019-08-31