FDA.reportPublic FDA data

Synthetic Polymer Teeth

Primary DI
06970402660338
Brand
Synthetic Polymer Teeth
Company
Huge Dental Material Co., Ltd.
Model
BLUEBELL
Catalog number
1*8*12
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101029000KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHHuge Dental Material Co., Ltd.2010-08-16ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970402660338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402660338069704026603386970402660338

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420283541
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970402660482PMMA BLOCKMonolayer1*1/BOX2016-09-09
06970402660499PMMA BLOCKMonolayer2*1/BOX2016-09-09
06970402660505PMMA BLOCKMonolayer3*1/BOX2016-09-09
06970402660512PMMA BLOCKMonolayer4*1/BOX2016-09-09
06970402660529PMMA BLOCKMonolayer5*1/BOX2016-09-09
06970402660536PMMA BLOCKMonolayer10*1/BOX2016-09-09
06970402660543PMMA BLOCKMultilayer1*1/BOX2016-09-09
06970402660550PMMA BLOCKMultilayer2*1/BOX2016-09-09
06970402660567PMMA BLOCKMultilayer3*1/BOX2016-09-09
06970402660574PMMA BLOCKMultilayer4*1/BOX2016-09-09
06970402660581PMMA BLOCKMultilayer5*1/BOX2016-09-09
06970402660598PMMA BLOCKMultilayer10*1/BOX2016-09-09
06970402660604PMMA BLOCKClear1*1/BOX2016-09-09
06970402660611PMMA BLOCKClear5*1/BOX2016-09-09
06970402661281PMMA BLOCKClear2*1/BOX2017-06-27
06970402661298PMMA BLOCKClear3*1/BOX2017-06-27
06970402661304PMMA BLOCKClear4*1/BOX2017-06-27
06970402661311PMMA BLOCKClear6*1/BOX2017-06-27
06970402661328PMMA BLOCKClear10*1/BOX2017-06-27
06970402661335PMMA BLOCKClear20*1/BOX2017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
EPOLCL02B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10