Carbon

FDA UDI

Class II (US FDA UDI)

by Keystone Industries

Identity

Trade Name: Carbon FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: FP3D Light Reddish Pink FDA UDI
Model / Reference: 4220441 FDA UDI
Description: FP3D Light Reddish Pink FDA UDI

Identifiers

Catalog Number: 4230441 FDA UDI
Primary DI / UDI-DI: H66842204410 FDA UDI
510(k) Number: K250489 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 16 Fluid Ounce FDA UDI

Category: Dental appliance fabrication material, resin

Carbon by Keystone Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental appliance fabrication material, resin.

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Cleared under the same submission

K250489 also covers:

Carbon — Keystone Industries
Carbon — Keystone Industries

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Keystone Industries

Sources (1)

FDA UDI 078c042f-4512-48f4-85a7-528b7b745232 38 fields · synced Jun 9, 2026