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Affordable

FDA UDI

Class II (US FDA UDI)

by Keystone Industries

Identity

Trade Name
Affordable FDA UDI
Generic Name
Dental appliance fabrication material, resin FDA UDI
Device Name
Pour Powder Lt. Fib Orig 1 lb FDA UDI
Model / Reference
1014230 FDA UDI
Description
Pour Powder Lt. Fib Orig 1 lb FDA UDI

Identifiers

Catalog Number
1014230 FDA UDI
Primary DI / UDI-DI
H66810142301 FDA UDI
510(k) Number
K983876 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
Not 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

Dimensions & Sizes

Size
Weight — 1 Pound FDA UDI

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

Cleared under the same submission

K983876 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Keystone Industries

Sources (1)

  • FDA UDI f8ff8e75-0d56-454c-8117-9e5d1234d32f 39 fields · synced Jun 9, 2026