FDA.reportPublic FDA data

Denture Base Polymers

Primary DI
06970402678036
Brand
Denture Base Polymers
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Type 2 class 1
Catalog number
(powder) 1kg
Published
2025-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K220680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220680000Denture Base PolymersShandong Huge Dental Material Corporation2022-08-12EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970402678036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402678036069704026780366970402678036

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
528184691
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412314672Milling Disc98×16mm/2S/Clear/1×12026-10-25
06909412314689Milling Disc98×16mm/2S/Pink/1×12026-10-25
06909412314696Milling Disc98×16mm/2S/Red/1×12026-10-25
06909412314702Milling Disc98×16mm/2S/Blue/1×12026-10-25
06909412314719Milling Disc98×16mm/2S/Orange/1×12026-10-25
06909412314726Milling Disc98×18mm/2S/Clear/1×12026-10-25
06909412314733Milling Disc98×18mm/2S/Pink/1×12026-10-25
06909412314740Milling Disc98×18mm/2S/Red/1×12026-10-25
06909412314757Milling Disc98×18mm/2S/Blue/1×12026-10-25
06909412314764Milling Disc98×18mm/2S/Orange/1×12026-10-25
06909412314771Milling Disc98×20mm/2S/Clear/1×12026-10-25
06909412314788Milling Disc98×20mm/2S/Pink/1×12026-10-25
06909412314795Milling Disc98×20mm/2S/Red/1×12026-10-25
06909412314801Milling Disc98×20mm/2S/Blue/1×12026-10-25
06909412314818Milling Disc98×20mm/2S/Orange/1×12026-10-25
06970402677596Denture Base PolymersType 1 class 1(A) Traditional Heat Curing/Powder 12026-10-25
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

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