FDA.reportPublic FDA data

Flexible Block

Primary DI
06909412305847
Brand
Flexible Block
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Monolayer
Catalog number
98*20 2S/Pink/1x1/Box
Published
2025-10-26
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213994000Flexible BlockShandong Huge Dental Material Corporation2022-03-04EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909412305847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909412305847069094123058476909412305847

Regulatory Flags#

DUNS number
528184691
Device count
1
Lot or batch
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
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
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480719567FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720396FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720402FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720617FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720624FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBI2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09