FDA.report

Dental Lithium Disilicate Glass Ceramic Block(Up.Press Series)

Primary DI
06941382264007
Brand
Dental Lithium Disilicate Glass Ceramic Block(Up.Press Series)
Company
Liaoning Upcera Co.,Ltd.
Model
HT C1-D(13-10)
Published
2025-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06941382264007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06941382264007069413822640076941382264007

GMDN Terms

TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
548214192
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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