FDA.report

NuSmile BioCem

Primary DI
00862487000337
Brand
NuSmile BioCem
Company
NUSMILE, LTD.
Model
BCK425XL
Device description
NuSmile Biocem 2.5 ml (12) mixing tip (blue)
Published
2017-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMACement, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00862487000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00862487000337008624870003378624870003370862487000337

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.

Device Sizes

TypeValueUnit
Total Volume2.5Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool dry place

Sterilization Methods

Method

Contacts

PhoneEmail
1800-346-5133info@nusmilecrowns.com

Regulatory Flags

DUNS number
185497372
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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