FDA.report

Opti-Cryl Heat Curing Acrylic Meharry X 1 lb

Primary DI
07701126642190
Brand
Opti-Cryl Heat Curing Acrylic Meharry X 1 lb
Company
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Model
81152
Catalog number
81152
Device description
Opti-Cryl Heat Curing Acrylic Meharry X 1 lb
Published
2017-05-22
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07701126642190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07701126642190077011266421907701126642190

GMDN Terms

TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
880141023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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07701126900962Portux 3D Printing Resin Try-In 002611000289612025-08-11
07701126900979Portux 3D Printing Resin Try-In.002896700289672025-08-11
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07701126901174PORTUX 3D Printing Resin Try-In A1002896000289602025-08-11
07701126901204Portux 3D Printing Resin Dental Models002007500200752025-08-11
07701126901211Portux 3D Printing Resin SG x 1000g0027364 0027364 2025-08-11
07701126901228Portux 3D Printing Resin Cast002736600273662025-08-11
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07701126615842Opti-Cryl Pour Acrylic Liquid X 8 oz1087451087452024-05-08
07701126615897Novacryl Self Curing Acrylic Liquid X 8 oz002570700257072024-05-08
07701126626336O-Cryl Self Curing Acrylic Shade White X 1 lb002010300201032024-05-08
07701126626343O-Cryl Self Curing Acrylic Shade Clear X 1 lb002319400231942024-05-08
07701126626350O-Cryl Self Curing Acrylic Liquid X 8 oz002319600231962024-05-08
07701126626374O-Cryl Self Curing Acrylic Shade Clear X 5 lb0024452 00244522024-05-08
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