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Shatkin FIRST Resin Cement Self-Cure

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name
Shatkin FIRST Resin Cement Self-Cure FDA UDI
Generic Name
Glass ionomer dental cement FDA UDI
Device Name
Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhesive. 6 gram Dual Barrel. Boxed. FDA UDI
Model / Reference
SFRC FDA UDI
Description
Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhesive. 6 gram Dual Barrel. Boxed. FDA UDI

Identifiers

Catalog Number
SFRC FDA UDI
Primary DI / UDI-DI
D801SFRC1 FDA UDI
510(k) Number
K884081 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Glass ionomer dental cement FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Shatkin FIRST Resin Cement Self-Cure by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K884081 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA UDI 0102f0c9-7810-4312-bfcf-88e9dd65287a 38 fields · synced Jun 8, 2026