FDA.reportPublic FDA data

Prodent

Primary DI
06970553800178
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
06970553800178PrimaryGS10
10697055380017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970553800178069705538001786970553800178
1069705538001710697055380017

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
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

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
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03
EBGO505321Mediloy RPDBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2023-05-12
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01L3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10