FDA.report

Resilience

Primary DI
00190730000170
Brand
Resilience
Company
ORTHO TECHNOLOGY, INC.
Model
FC-GRAN-061
Device description
Paste/Paste Ionomer Econo Kit 4x 5gm base/4x 5gm catalyst
Published
2016-09-24
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

Product Codes

CodeName
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190730000170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730000170001907300001701907300001700190730000170

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature35 Degrees Fahrenheit50 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
781772017
Device count
1
DM exempt
true
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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