Pink CAD/CAM Disc PMMP.483

GUDID EPOLPMMP48303

Denture base resin heat-cured

POLIDENT d.o.o.

Custom-made dental crown, polymer
Primary Device IDEPOLPMMP48303
NIH Device Record Keyddaaa967-4cbd-42ce-b2e8-fe4e6efb4203
Commercial Distribution StatusIn Commercial Distribution
Brand NamePink CAD/CAM Disc
Version Model NumberPMMP.483
Catalog NumberPMMP.483
Company DUNS644778409
Company NamePOLIDENT d.o.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si
Phone+38653304840
Emailpolident@polident.si

Device Dimensions

Device Size Text, specify0
Outer Diameter3 Meter
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Storage Environment TemperatureBetween -30 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPOLPMMP483 [Primary]
HIBCCEPOLPMMP48303 [Package]
Contains: EPOLPMMP483
Package: plastic card [1 Units]
Discontinued: 2021-06-15
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EPOLPMMP48303]

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[EPOLPMMP48303]

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[EPOLPMMP48303]

Dry Heat Sterilization


[EPOLPMMP48303]

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[EPOLPMMP48303]

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[EPOLPMMP48303]

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[EPOLPMMP48303]

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[EPOLPMMP48303]

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[EPOLPMMP48303]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-23
Device Publish Date2021-06-15

On-Brand Devices [Pink CAD/CAM Disc]

EPOLPMMP67903Denture base resin heat-cured
EPOLPMMP66203Denture base resin heat-cured
EPOLPMMP66003Denture base resin heat-cured
EPOLPMMP49003Denture base resin heat-cured
EPOLPMMP48903Denture base resin heat-cured
EPOLPMMP48803Denture base resin heat-cured
EPOLPMMP48703Denture base resin heat-cured
EPOLPMMP48603Denture base resin heat-cured
EPOLPMMP48503Denture base resin heat-cured
EPOLPMMP48403Denture base resin heat-cured
EPOLPMMP48303Denture base resin heat-cured
EPOLPMMP48203Denture base resin heat-cured
EPOLPMMP48103Denture base resin heat-cured

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