FDA.reportPublic FDA data

Prodent

Primary DI
06970553800079
Brand
Prodent
Company
Prodent Dental Technology (Shenzhen) Co., Ltd.
Model
N/A
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
EJHAlloy, Metal, Base
ELLTeeth, Porcelain
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2
ELLTeeth, PorcelainDental2
ELMDenture, Plastic, TeethDental2

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
06970553800079PrimaryGS10
10697055380007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970553800079069705538000796970553800079
1069705538000710697055380007

GMDN Terms#

Term, Definition table
TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421194088
Device count
3
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
06970553800003Prodent1389722016-08-26
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
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
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
07630813462639TCR MultiCandulor AGELM2026-07-28
07630813462646TCR MultiCandulor AGELM2026-07-28
07630813462653TCR MultiCandulor AGELM2026-07-28
07630813462660TCR MultiCandulor AGELM2026-07-28
07630813462677TCR MultiCandulor AGELM2026-07-28
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
03760357974917Prime V Disc 98.5 x13.5 mmBERNARD CERVOS SOCIETEEJH2026-06-09