Pink CAD/CAM Disc PMMP.488

GUDID EPOLPMMP48803

Denture base resin heat-cured

POLIDENT d.o.o.

Custom-made dental crown, polymer
Primary Device IDEPOLPMMP48803
NIH Device Record Key3843021d-0a68-4c29-bd18-54525c26000a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePink CAD/CAM Disc
Version Model NumberPMMP.488
Catalog NumberPMMP.488
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

Outer Diameter3 Meter
Device Size Text, specify0
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
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Outer Diameter3 Meter
Device Size Text, specify0

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
HIBCCEPOLPMMP488 [Primary]
HIBCCEPOLPMMP48803 [Package]
Contains: EPOLPMMP488
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

[EPOLPMMP48803]

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[EPOLPMMP48803]

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[EPOLPMMP48803]

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[EPOLPMMP48803]

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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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