FDA.reportPublic FDA data

PMMA BLOCK

Primary DI
06975187610035
Brand
PMMA BLOCK
Company
Huliang(Shanghai) Biotech Co., Ltd.
Model
Shade: A2; Spec:98*10mm; Net Weight:87g
Published
2023-12-28
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
K223706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223706000PMMA BLOCKHuliang(Shanghai) Bio-Tech Co., Ltd.2023-05-12EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975187610035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975187610035069751876100356975187610035

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
412706288
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975187610004PMMA BLOCKShade: A1; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610011PMMA BLOCKShade: BL; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610042PMMA BLOCKShade: A3; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610059PMMA BLOCKShade: A3.5; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610066PMMA BLOCKShade: A4; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610073PMMA BLOCKShade: B1; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610080PMMA BLOCKShade: B2; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610097PMMA BLOCKShade: B3; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610110PMMA BLOCKShade: B4; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610127PMMA BLOCKShade: C1; Spec:98*10mm; Net Weight:87g2023-12-28
06975187610134PMMA BLOCKShade: C2; Spec:98*10mm; Net Weight:87g2023-12-28
06975187611315PMMA BLOCKShade:ML A1; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611322PMMA BLOCKShade:ML B1; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611339PMMA BLOCKShade:ML A2; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611346PMMA BLOCKShade:ML A3; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611377PMMA BLOCKShade:ML B2; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611407PMMA BLOCKShade:ML C1; Spec:98*16mm; Net Weight:140g2023-07-20
06975187611414PMMA BLOCKShade:ML C2; Spec:98*16mm; Net Weight:140g2023-07-20
06975187612008PMMA BLOCKShade:Pink; Spec:98*20mm; Net Weight:175g2023-07-20
06975187612015PMMA BLOCKShade:Clear; Spec:98*20mm; Net Weight:175g2023-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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