FDA.reportPublic FDA data

EdgeTemp™ Plus Hydraulic Temporary Restorative Material

Primary DI
00818365021031
Brand
EdgeTemp™ Plus Hydraulic Temporary Restorative Material
Company
EDGE ENDO LLC
Model
ETEMPPLUS
Device description
EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is individually boxed. EdgeTemp™ Plus is a water-based temporary filling material used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190724000MD-Temp PlusMeta Biomed Co., Ltd.2019-07-03EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365021031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365021031008183650210318183650210310818365021031

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used 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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight40Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078474365
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818365020027EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-01-25
D858EETEMP0LEdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-12
D858EETEMP1230EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-11
10818365020994Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021014Edge™ EarLoop Procedure Masks572201657220162020-02-06
10818365020932Edge™ EarLoop Procedure Masks”572200957220092020-02-06
10818365020949Edge™ EarLoop Procedure Masks572200857220082020-02-06
10818365020956Edge™ EarLoop Procedure Masks572200657220062020-02-06
10818365020963Edge™ EarLoop Procedure Masks572235257223522020-02-06
10818365020970Edge™ EarLoop Procedure Masks572201357220132020-02-06
10818365020987Edge™ EarLoop Procedure Masks572201157220112020-02-06
20818365020991Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021007Edge™ EarLoop Procedure Masks572201557220152020-02-06
20818365021011Edge™ EarLoop Procedure Masks572201657220162020-02-06
00818365020096EdgeSurgicalTip™ #1AS3D12018-06-10
00818365020102EdgeSurgicalTip™ #2AS3D22018-06-10
00818365020119EdgeSurgical Tip™ #3P15LD2018-06-10
00818365020126EdgeSurgicalTip™ #4ASLD2018-06-10
00818365020133EdgeSurgicalTip™ #5P15RD2018-06-10
00818365020140EdgeSurgicalTip™ #6ASRD2018-06-10

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Primary DI, Brand, Company table
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