FDA.reportPublic FDA data

PMMA BLOCK

Primary DI
06970402677176
Brand
PMMA BLOCK
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Monolayer
Catalog number
13*1/BOX
Published
2021-10-22
Public version status
New
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
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201683000PMMA BlockHuge Dental Material Co., Ltd.2020-11-03EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970402677176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402677176069704026771766970402677176

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528184691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412319455Dental ModelM 2.01.0 kg/bottle2026-05-19
06909412319929Porcelain PowdersPowderA/10g2026-05-19
06909412319936Porcelain PowdersPowderB/10g2026-05-19
06909412320024Porcelain PowdersBlending LiquidL1/20mL2026-05-19
06909412320031Porcelain PowdersBlending LiquidL2/20mL2026-05-19
06909412320048Porcelain PowdersStain/GlazeA/5g2026-05-19
06909412320055Porcelain PowdersStain/GlazeB/5g2026-05-19
06909412320246Porcelain Powders/K-001-162026-05-19
06909412327825Dental ModelM 3.01.0 kg/bottle2026-05-19
06909412327900Denture BaseDB2S/500 g/bottle2026-05-19
06909412327917Denture BaseDB2S/1.0 kg/bottle2026-05-19
06909412327924Denture BaseDBPink/500 g/bottle2026-05-19
06909412327931Denture BaseDBPink/1.0 kg/bottle2026-05-19
06909412327948Denture BaseDBPink1/500 g/bottle2026-05-19
06909412327955Denture BaseDBPink1/1.0 kg/bottle2026-05-19
06909412327962Denture BaseDBPink2/500 g/bottle2026-05-19
06909412327979Denture BaseDBPink2/1.0 kg/bottle2026-05-19
06909412327986Denture BaseDBPink3/500 g/bottle2026-05-19
06909412327993Denture BaseDBPink3/1.0 kg/bottle2026-05-19
06909412328006Denture BaseDBPink4/500 g/bottle2026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
D9821716301LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
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D9821716331LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716341LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716351LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716361LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716371LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21