FDA.reportPublic FDA data

Zirconia Block

Primary DI
06909412358546
Brand
Zirconia Block
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
MM-4D
Catalog number
/
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909412358546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909412358546069094123585466909412358546

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Regulatory Flags#

DUNS number
528184691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
06970402679958Elastomeric Impression MaterialType 0 (Putty Hand-Mix)25g Catalyst*402026-10-26

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