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Opti-Cryl High Impact Acrylic Original x 5 lb

FDA UDI

Class II (US FDA UDI)

by Productora Y Comercializadora Odontologica New Stetic S A

Identity

Trade Name
Opti-Cryl High Impact Acrylic Original x 5 lb FDA UDI
Generic Name
Dental appliance fabrication material, resin FDA UDI
Device Name
Opti-Cryl High Impact Acrylic Original x 5 lb FDA UDI
Model / Reference
83268 FDA UDI
Description
Opti-Cryl High Impact Acrylic Original x 5 lb FDA UDI

Identifiers

Catalog Number
83268 FDA UDI
Primary DI / UDI-DI
07701126643050 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, resin

Opti-Cryl High Impact Acrylic Original x 5 lb by Productora Y Comercializadora Odontologica New Stetic S A — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental appliance fabrication material, resin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 46464f8d-d638-4975-85c3-154fd7e48676 34 fields · synced Jun 8, 2026