PORTUX CAD/CAM Disc. 98.5X18mm A3. MN 0022093

GUDID 07701126712220

PORTUX CAD/CAM Disc. 98.5X18mm A3. MN

PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Temporary dental crown/bridge resin
Primary Device ID07701126712220
NIH Device Record Key1cd6467c-2379-48a1-8088-4a5086899b87
Commercial Distribution StatusIn Commercial Distribution
Brand NamePORTUX CAD/CAM Disc. 98.5X18mm A3. MN
Version Model Number0022093
Catalog Number0022093
Company DUNS880141023
Company NamePRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107701126712220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-15
Device Publish Date2024-03-07

Devices Manufactured by PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

00770112663119 - Opti-Cryl Pour Acrylic Original X 22 lb2024-05-16 Opti-Cryl Pour Acrylic Original X 22 lb
07701126615842 - Opti-Cryl Pour Acrylic Liquid X 8 oz2024-05-16 Opti-Cryl Pour Acrylic Liquid X 8 oz
07701126615897 - Novacryl Self Curing Acrylic Liquid X 8 oz2024-05-16 Novacryl Self Curing Acrylic Liquid X 8 oz
07701126626336 - O-Cryl Self Curing Acrylic Shade White X 1 lb2024-05-16 O-Cryl Self Curing Acrylic Shade White X 1 lb
07701126626343 - O-Cryl Self Curing Acrylic Shade Clear X 1 lb2024-05-16 O-Cryl Self Curing Acrylic Shade Clear X 1 lb
07701126626350 - O-Cryl Self Curing Acrylic Liquid X 8 oz2024-05-16 O-Cryl Self Curing Acrylic Liquid X 8 oz
07701126626374 - O-Cryl Self Curing Acrylic Shade Clear X 5 lb2024-05-16 O-Cryl Self Curing Acrylic Shade Clear X 5 lb
07701126631156 - Opti-Cryl Pour Acrylic Original X 1 lb2024-05-16 Opti-Cryl Pour Acrylic Original X 1 lb

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.