FDA.reportPublic FDA data

PMMA BLOCK

Primary DI
06970402677244
Brand
PMMA BLOCK
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Multilayer
Catalog number
4*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
06970402677244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402677244069704026772446970402677244

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
06909412304789Elastomeric Impression MaterialType 0 (Putty Hand-Mix Fast Set)400g base+400g catalyst/box2026-10-26
06909412313088Light Curing Tray/Mint/Blue, 2.3mm, 2 pieces*12026-10-26
06909412313095Light Curing Tray/Mint/Blue, 2.3mm, 50 pieces*12026-10-26
06909412313163Elastomeric Impression MaterialType 3 (Light Body Dispenser-Mix Fast Set)50ml/bio-cartridge, 2 bio-cartridges/box2026-10-26
06909412313170Elastomeric Impression MaterialType 1 (Heavy Body Dispenser-Mix Fast Set)50ml/bio-cartridge, 2 bio-cartridges/box/Mixer(Whi2026-10-26
06909412313187Elastomeric Impression MaterialType 1 (Heavy Body Dispenser-Mix Normal Set)50ml/bio-cartridge, 2 bio-cartridges/box/Mixer(Whi2026-10-26
06909412319448Firing Paste/10mL2026-10-26
06909412320192Light Curing Tray/Mint/Pink, 1.6mm, 50 pieces*12026-10-26
06909412320222Light Curing Tray/Mint/Blue, 1.6mm, 50 pieces*12026-10-26
06909412320413Light Curing Tray/Mint/Pink, 1.6mm, 2 pieces*12026-10-26
06909412320420Light Curing Tray/Mint/Pink, 2.0mm, 2 pieces*12026-10-26
06909412320437Light Curing Tray/Mint/Blue, 2.0mm, 2 pieces*12026-10-26
06909412358546Zirconia BlockMM-4D/2026-10-26
06970402679033Light Curing Tray/Mint/Pink, 2.0mm, 50 pieces*12026-10-26
06970402679040Light Curing Tray/Mint/Blue, 2.0mm, 50 pieces*12026-10-26
06970402679057Light Curing Tray/Mint/Pink, 1.4mm, 50 pieces*12026-10-26
06970402679064Light Curing Tray/Mint/Blue, 1.4mm, 50 pieces*12026-10-26
06970402679309Light Curing Tray/Mint/Pink, 2.3mm, 2 pieces*12026-10-26
06970402679927Light Curing Tray/Mint/Pink, 2.3mm, 50 pieces*12026-10-26
06970402679941Elastomeric Impression MaterialType 0 (Putty Hand-Mix)25g Base*402026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314788Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06970402677596Denture Base PolymersSHANDONG HUGE DENTAL MATERIAL CORPORATIONEBI2026-10-25
00842326128132DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128149DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128156DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
06942480706086FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707618FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707632FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707649FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707724FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707809FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707823FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707830FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19