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Nature-Cryl®

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
NATURE-CRYL® FDA UDI
Generic Name
Denture base resin, heat-cured FDA UDI
Device Name
NATURE-CRYL® MC LIGHT 1:1 PKG (1Ib powder, 8oz liquid) FDA UDI
Model / Reference
349664 FDA UDI
Description
NATURE-CRYL® MC LIGHT 1:1 PKG (1Ib powder, 8oz liquid) FDA UDI

Identifiers

Catalog Number
349664 FDA UDI
Primary DI / UDI-DI
D6583496641 FDA UDI
510(k) Number
K991774 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture base resin, heat-cured 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

No

FDA UDI

Category: Denture base resin, heat-cured

Nature-Cryl® by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture base resin, heat-cured.

Cleared under the same submission

K991774 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI 3ed4b768-93bd-4bc7-a084-abd823b8c99a 37 fields · synced Jun 8, 2026